You cannot select more than 25 topics
Topics must start with a letter or number, can include dashes ('-') and can be up to 35 characters long.
2892 lines
181 KiB
HTML
2892 lines
181 KiB
HTML
<!DOCTYPE html>
|
|
<html xmlns="http://www.w3.org/1999/xhtml" lang='en'>
|
|
|
|
<head>
|
|
<meta charset="UTF-8">
|
|
<title>History of Changes for Study: NCT00658567</title>
|
|
<script src="html/images/../jquery/js/jquery.min.js?v=3.5.1"></script><noscript></noscript>
|
|
<link rel="stylesheet" type="text/css" href="html/css/HistoryDiffsStyle.css?v=b40">
|
|
<link rel="stylesheet" type="text/css" href="html/css/w3-ct.css?v=b36">
|
|
<meta name="viewport" content="width=device-width, initial-scale=1">
|
|
<meta name="ncbi_app" content="ctgov-archive" />
|
|
<meta name="ncbi_db" content="ctgov" />
|
|
<meta name="ncbi_pdid" content="HomePage" />
|
|
</head>
|
|
|
|
<body>
|
|
<div id="ArchiveHeader" class="wrapper"><img class="responsive-image"
|
|
src="html/images/ct.gov-nlm-nih-archive-logo.png" alt="ClinicalTrials.gov" style="margin:2px;">
|
|
</div>
|
|
<hr class="fancyDivider" style="clear:both;">
|
|
<div id="controls" class="wrapper">
|
|
<div style="text-align:center;font-size:larger;font-weight:bold;padding:14px 10px 0;">History of Changes for Study:
|
|
NCT00658567</div>
|
|
<div style="text-align:center;font-size:larger;font-weight:bold;padding:14px 10px;">A Study of Safety and Efficacy
|
|
of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis</div>
|
|
<div style="text-align:center;font-size:smaller;margin-bottom:10px;"><a
|
|
href="https://clinicaltrials.gov/ct2/show/NCT00658567">Latest version (submitted April 18, 2017) on
|
|
ClinicalTrials.gov</a></div>
|
|
<div style="clear:both;"></div>
|
|
<div class="w3-container">
|
|
<div class="w3-row">
|
|
<div class="w3-col l4" style="float:right;">
|
|
<div style="font-size:smaller;padding:10px; color:navy;">
|
|
<ul class="instructions">
|
|
<li>A study version is represented by a row in the table.</li>
|
|
<li>Select two study versions to compare. One each from columns A and B.</li>
|
|
<li>Choose either the "Merged" or "Side-by-Side" comparison format to specify how the
|
|
two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of
|
|
the study.</li>
|
|
<li>Click "Compare" to do the comparison and show the differences.</li>
|
|
<li>Select a version's Submitted Date link to see a rendering of the study for that version.</li>
|
|
<li>The <span style="background-color: lightyellow;"> yellow A/B </span>choices in the table indicate the
|
|
study versions currently compared below. A<span style="background-color: lightyellow;"> yellow
|
|
</span>table row indicates the study version currently being viewed.</li>
|
|
<li>Hover over the "<span class="recruitmentStatus">Recruitment Status</span>" to see how the
|
|
study's recruitment status changed.</li>
|
|
<li>Study edits or deletions are displayed in <span class="drop_hilite">red</span>.</li>
|
|
<li>Study additions are displayed in <span class="add_hilite">green</span>.</li>
|
|
</ul>
|
|
</div>
|
|
</div>
|
|
<div class="w3-col l8" style="float:left;">
|
|
<form action="#StudyPageTop" data-ncbi-sg-search="true" onsubmit="sendSearchPing();" method="GET">
|
|
<div class="w3-responsive">
|
|
<fieldset class="releases ct-StdBackground">
|
|
<legend class="releases">Study Record Versions</legend>
|
|
<table class="w3-bordered releases">
|
|
<thead>
|
|
<tr>
|
|
<th style="text-align:center;border-right:1px solid dimgrey;" id="VersionNumber">Version</th>
|
|
<th style="text-align:center;border-right:1px solid dimgrey;" id="ColumnA">A</th>
|
|
<th style="text-align:center;border-right:1px solid dimgrey;" id="ColumnB">B</th>
|
|
<th style="text-align:center;border-right:1px solid dimgrey;white-space:nowrap;" id="VersionDate">
|
|
Submitted Date</th>
|
|
<th style="text-align:center; width:100%;" id="Changes">Changes</th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td headers="VersionNumber">1</td>
|
|
<td headers="ColumnA" class="currentChoice"><input type="radio" name="A"
|
|
title="Column A, study version 1" value="1" checked></td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 1" value="1">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_1=View#StudyPageTop" title="View study version (1) dated April 10, 2008">April 10,
|
|
2008</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">None (earliest Version on record)
|
|
<tr>
|
|
<td headers="VersionNumber">2</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 2" value="2">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 2" value="2">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_2=View#StudyPageTop" title="View study version (2) dated May 19, 2008">May 19,
|
|
2008</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">3</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 3" value="3">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 3" value="3">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_3=View#StudyPageTop" title="View study version (3) dated August 25, 2008">August 25,
|
|
2008</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">4</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 4" value="4">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 4" value="4">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_4=View#StudyPageTop"
|
|
title="View study version (4) dated September 24, 2008">September 24, 2008</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">5</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 5" value="5">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 5" value="5">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_5=View#StudyPageTop" title="View study version (5) dated October 20, 2008">October
|
|
20, 2008</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">6</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 6" value="6">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 6" value="6">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_6=View#StudyPageTop" title="View study version (6) dated November 17, 2008">November
|
|
17, 2008</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">7</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 7" value="7">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 7" value="7">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_7=View#StudyPageTop" title="View study version (7) dated December 17, 2008">December
|
|
17, 2008</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Contacts/Locations, Study Status and Eligibility
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">8</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 8" value="8">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 8" value="8">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_8=View#StudyPageTop" title="View study version (8) dated February 16, 2009">February
|
|
16, 2009</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">9</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 9" value="9">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 9" value="9">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_9=View#StudyPageTop" title="View study version (9) dated March 26, 2009">March 26,
|
|
2009</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">10</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 10" value="10">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 10" value="10">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_10=View#StudyPageTop" title="View study version (10) dated April 16, 2009">April 16,
|
|
2009</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">11</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 11" value="11">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 11" value="11">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_11=View#StudyPageTop" title="View study version (11) dated June 16, 2009">June 16,
|
|
2009</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">12</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 12" value="12">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 12" value="12">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_12=View#StudyPageTop" title="View study version (12) dated July 16, 2009">July 16,
|
|
2009</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">13</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 13" value="13">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 13" value="13">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_13=View#StudyPageTop" title="View study version (13) dated August 4, 2010">August 4,
|
|
2010</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes"><span class="recruitmentStatus"
|
|
title="Recruiting --> Completed">Recruitment Status</span>, Study Status, Contacts/Locations
|
|
and Sponsor/Collaborators</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">14</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 14" value="14">
|
|
</td>
|
|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 14" value="14">
|
|
</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_14=View#StudyPageTop" title="View study version (14) dated August 29, 2014">August
|
|
29, 2014</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Study Status, Outcome Measures,
|
|
Sponsor/Collaborators, Arms and Interventions, Study Design, Results and Eligibility</td>
|
|
</tr>
|
|
<tr>
|
|
<td headers="VersionNumber">15</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 15" value="15">
|
|
</td>
|
|
<td headers="ColumnB" class="currentChoice"><input type="radio" name="B"
|
|
title="Column B, study version 15" value="15" checked></td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_15=View#StudyPageTop" title="View study version (15) dated April 18, 2017">April 18,
|
|
2017</a>
|
|
</td>
|
|
<td style="text-align:left;" headers="Changes">Oversight, Study Status, IPDSharing and
|
|
Contacts/Locations</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
<div class="w3-left-align" style="margin-top:10px;">
|
|
<input type="submit" class="compareButton" value="Compare" title="Compare" autofocus />
|
|
<div class="controls">
|
|
<span style="white-space:nowrap;">Comparison Format:</span>
|
|
<ul class="format w3-left-align">
|
|
<li><label for="mergedCB" title="Use merged format everywhere">
|
|
<input type="radio" id="mergedCB" name="C" value="merged" checked> Merged
|
|
</label></li>
|
|
<li><label for="sbsCB" title="Side-by-Side (applies only to Protocol Section)">
|
|
<input type="radio" id="sbsCB" name="C" value="Side-by-Side"> Side-by-Side
|
|
</label></li>
|
|
</ul>
|
|
</div>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</div>
|
|
</div>
|
|
</div>
|
|
</div>
|
|
<a id="StudyPageTop"></a>
|
|
<hr class="fancyDivider" style="margin:2px auto;">
|
|
<div style="padding:3px;text-align:center;font-size:smaller;color:grey;"><a href="javascript:;"
|
|
onClick="document.getElementById('controls').scrollIntoView();">Scroll up to access the controls</a></div>
|
|
<hr class="fancyDivider" style="margin:2px auto 6px auto;">
|
|
<div class="wrapper" style="text-align:center;font-weight:bold;">
|
|
Changes (Merged) for Study: NCT00658567<br>
|
|
April 10, 2008 (v1) -- April 18, 2017 (v15)<br><br>Changes in: <a href="#StudyStatus" target="_self"
|
|
title="Jump to the Study Status module" style="white-space:nowrap;">Study Status</a>, <a
|
|
href="#SponsorCollaborators" target="_self" title="Jump to the Sponsor/Collaborators module"
|
|
style="white-space:nowrap;">Sponsor/Collaborators</a>, <a href="#Oversight" target="_self"
|
|
title="Jump to the Oversight module" style="white-space:nowrap;">Oversight</a>, <a href="#StudyDesign"
|
|
target="_self" title="Jump to the Study Design module" style="white-space:nowrap;">Study Design</a>, <a
|
|
href="#ArmsandInterventions" target="_self" title="Jump to the Arms and Interventions module"
|
|
style="white-space:nowrap;">Arms and Interventions</a>, <a href="#ROutcomeMeasures" target="_self"
|
|
title="Jump to the Outcome Measures module" style="white-space:nowrap;">Outcome Measures</a>, <a
|
|
href="#Eligibility" target="_self" title="Jump to the Eligibility module"
|
|
style="white-space:nowrap;">Eligibility</a>, <a href="#ContactsLocations" target="_self"
|
|
title="Jump to the Contacts/Locations module" style="white-space:nowrap;">Contacts/Locations</a>, <a
|
|
href="#IPDSharing" target="_self" title="Jump to the IPDSharing module" style="white-space:nowrap;">IPDSharing</a>
|
|
and <a href="#Results" target="_self" title="Jump to the Results module" style="white-space:nowrap;">Results</a>
|
|
<script type="text/javascript">
|
|
$(window).on("load", function () {
|
|
var hash = window.location.hash;
|
|
if (hash !== null && hash != "") {
|
|
$(hash).get(0).scrollIntoView(true);
|
|
}
|
|
}); function toggleModule(theModuleId) {
|
|
var theModuleBody = $('#' + theModuleId + 'Body');
|
|
$('#' + theModuleId + 'Img').attr("src", (theModuleBody.css("display") == "none") ?
|
|
"html/images/collapse.png" : "html/images/expand.png");
|
|
theModuleBody.fadeToggle('slow');
|
|
};
|
|
</script><noscript></noscript>
|
|
<div style="margin-top:1ex;padding:4px;"><label for="OpenOnlyChangedModules">
|
|
<input type="checkbox" id="OpenOnlyChangedModules" style="vertical-align:text-bottom;"
|
|
onchange="setOpenOnlyChangedModules()"> Show only changed modules</label></div>
|
|
<script type="text/javascript">
|
|
var ChangedModules = [];
|
|
var theModule = "StudyStatus"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
var theModule = "SponsorCollaborators"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
var theModule = "Oversight"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
var theModule = "StudyDesign"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
var theModule = "ArmsandInterventions"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
var theModule = "ROutcomeMeasures"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
var theModule = "Eligibility"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
var theModule = "ContactsLocations"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
var theModule = "IPDSharing"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
var theModule = "Results"; ChangedModules.push(theModule);
|
|
if (theModule === "ROutcomeMeasures") ChangedModules.push("ProtocolOutcomeMeasures");
|
|
ChangedModules.push("ParticipantFlow");
|
|
ChangedModules.push("BaselineCharacteristics");
|
|
ChangedModules.push("ROutcomeMeasures");
|
|
ChangedModules.push("ProtocolOutcomeMeasures");
|
|
ChangedModules.push("AdverseEvents");
|
|
ChangedModules.push("LimitationsandCaveats");
|
|
ChangedModules.push("MoreInformation");
|
|
var OpenOnlyChangedModules = false;
|
|
function getIndexOf(theArray, theValue) {
|
|
if (theArray === null || theValue === null) return -1;
|
|
for (var i = 0; i < theArray.length; ++i) {
|
|
if (theArray[i] == theValue) return i;
|
|
}
|
|
return -1;
|
|
};
|
|
function setOpenOnlyChangedModules() {
|
|
var cbChecked = $('#OpenOnlyChangedModules').is(':checked'); if (cbChecked === OpenOnlyChangedModules) return;
|
|
OpenOnlyChangedModules = cbChecked;
|
|
localStorage.setItem('CT_Archive_OpenOnlyChangedModules', JSON.stringify(OpenOnlyChangedModules));
|
|
resetAllModules();
|
|
};
|
|
function resetAllModules() {
|
|
var theModules = $(".moduleBody");
|
|
theModules.each(function () {
|
|
var myIdBody = $(this).attr("id");
|
|
var myId = myIdBody.slice(0, myIdBody.indexOf('Body'));
|
|
if (!OpenOnlyChangedModules) {
|
|
forceOpenModule(myId);
|
|
} else {
|
|
(getIndexOf(ChangedModules, myId) >= 0) ?
|
|
forceOpenModule(myId) : forceCloseModule(myId);
|
|
};
|
|
});
|
|
};
|
|
function closeModuleIfNotChanged(theModuleId) {
|
|
if (!OpenOnlyChangedModules) return;
|
|
if (getIndexOf(ChangedModules, theModuleId) < 0) {
|
|
forceCloseModule(theModuleId);
|
|
}
|
|
}
|
|
$(document).ready(function () {
|
|
try {
|
|
OpenOnlyChangedModules = JSON.parse(localStorage.getItem('CT_Archive_OpenOnlyChangedModules'));
|
|
if (OpenOnlyChangedModules === null) { OpenOnlyChangedModules = false; };
|
|
} catch (e) { OpenOnlyChangedModules = false; };
|
|
if (!OpenOnlyChangedModules) return;
|
|
$('#OpenOnlyChangedModules').prop('checked', true);
|
|
resetAllModules();
|
|
var theModules = $(".moduleBody");
|
|
theModules.each(function () {
|
|
var myIdBody = $(this).attr("id");
|
|
var myId = myIdBody.slice(0, myIdBody.indexOf('Body'));
|
|
closeModuleIfNotChanged(myId);
|
|
});
|
|
});
|
|
function forceCloseModule(theModuleId) {
|
|
var theModuleBody = $('#' + theModuleId + 'Body');
|
|
$('#' + theModuleId + 'Img').attr("src", "html/images/expand.png");
|
|
theModuleBody.fadeOut('fast');
|
|
};
|
|
function forceOpenModule(theModuleId) {
|
|
var theModuleBody = $('#' + theModuleId + 'Body');
|
|
$('#' + theModuleId + 'Img').attr("src", "html/images/collapse.png");
|
|
theModuleBody.fadeIn('fast');
|
|
};
|
|
</script><noscript></noscript>
|
|
</div>
|
|
<hr>
|
|
<table class="history">
|
|
<thead>
|
|
<tr>
|
|
<th></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td colspan="2"><a id="Protocol"></a></td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyIdentification">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="StudyIdentification"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyIdentificationImg" class="toggleImage"
|
|
onclick="toggleModule('StudyIdentification');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Study Identification</legend>
|
|
<div id="StudyIdentificationBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Unique Protocol ID:</td>
|
|
<td>ACP-103-014 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Brief Title:</td>
|
|
<td>A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's
|
|
Disease Psychosis </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Official Title:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Secondary IDs:</td>
|
|
<td></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyStatus">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="StudyStatus"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyStatusImg" class="toggleImage"
|
|
onclick="toggleModule('StudyStatus');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Study Status</legend>
|
|
<div id="StudyStatusBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Record Verification:</td>
|
|
<td>April <span class="drop_hilite">2008</span> <span class="add_hilite">2017</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Overall Status:</td>
|
|
<td><span class="drop_hilite">Recruiting</span> <span class="add_hilite">Completed</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Start:</td>
|
|
<td>March 2008 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Primary Completion:</td>
|
|
<td> <span class="add_hilite">December 2009 [Actual]</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Completion:</td>
|
|
<td>December 2009 [ <span class="drop_hilite">Anticipated</span> <span
|
|
class="add_hilite">Actual</span>] </td>
|
|
</tr>
|
|
<tr style="border-bottom:1px solid lightgray">
|
|
<td colspan="3"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">First Submitted:</td>
|
|
<td>April 10, 2008 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">First Submitted that<br />Met QC Criteria:</td>
|
|
<td>April 10, 2008 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">First Posted:</td>
|
|
<td>April 15, 2008 [Estimate] </td>
|
|
</tr>
|
|
<tr style="border-bottom:1px solid lightgray">
|
|
<td colspan="3"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Results First Submitted:</td>
|
|
<td> <span class="add_hilite">February 6, 2014</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Results First Submitted that<br />Met QC
|
|
Criteria:</td>
|
|
<td> <span class="add_hilite">August 29, 2014</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Results First Posted:</td>
|
|
<td> <span class="add_hilite">September 9, 2014 [Estimate]</span> </td>
|
|
</tr>
|
|
<tr style="border-bottom:1px solid lightgray">
|
|
<td colspan="3"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Last Update Submitted that<br />Met QC Criteria:
|
|
</td>
|
|
<td>April <span class="drop_hilite">10</span> <span class="add_hilite">18</span>, <span
|
|
class="drop_hilite">2008</span> <span class="add_hilite">2017</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Last Update Posted:</td>
|
|
<td><span class="drop_hilite">April 15, 2008 [Estimate]</span> <span class="add_hilite">May 19,
|
|
2017 [Actual]</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_SponsorCollaborators">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="SponsorCollaborators"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="SponsorCollaboratorsImg" class="toggleImage"
|
|
onclick="toggleModule('SponsorCollaborators');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Sponsor/Collaborators</legend>
|
|
<div id="SponsorCollaboratorsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Sponsor:</td>
|
|
<td>ACADIA Pharmaceuticals Inc. </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Responsible Party:</td>
|
|
<td> <span class="add_hilite">Sponsor</span> </td>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Collaborators:</td>
|
|
<td></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_Oversight">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="Oversight"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="OversightImg" class="toggleImage"
|
|
onclick="toggleModule('Oversight');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Oversight</legend>
|
|
<div id="OversightBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">U.S. FDA-regulated Drug:</td>
|
|
<td> <span class="add_hilite">Yes</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">U.S. FDA-regulated Device:</td>
|
|
<td> <span class="add_hilite">No</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Data Monitoring:</td>
|
|
<td> <span class="add_hilite">No</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyDescription">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="StudyDescription"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyDescriptionImg" class="toggleImage"
|
|
onclick="toggleModule('StudyDescription');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Study Description</legend>
|
|
<div id="StudyDescriptionBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Brief Summary:</td>
|
|
<td>This study will evaluate the safety and efficacy of two dose levels of pimavanserin
|
|
(ACP-103) compared to placebo in patients with Parkinson's disease psychosis. </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Detailed Description:</td>
|
|
<td></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_Conditions">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="Conditions"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ConditionsImg" class="toggleImage"
|
|
onclick="toggleModule('Conditions');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Conditions</legend>
|
|
<div id="ConditionsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Conditions:</td>
|
|
<td>Parkinson's Disease Psychosis </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Keywords:</td>
|
|
<td></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyDesign">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="StudyDesign"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyDesignImg" class="toggleImage"
|
|
onclick="toggleModule('StudyDesign');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Study Design</legend>
|
|
<div id="StudyDesignBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Type:</td>
|
|
<td>Interventional</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Primary Purpose:</td>
|
|
<td>Treatment</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Phase:</td>
|
|
<td>Phase 3</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Interventional Study Model:</td>
|
|
<td>Parallel Assignment </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Number of Arms:</td>
|
|
<td>3</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Masking:</td>
|
|
<td>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Allocation:</td>
|
|
<td>Randomized</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Enrollment:</td>
|
|
<td><span class="drop_hilite">240 [Anticipated]</span> <span class="add_hilite">123
|
|
[Actual]</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_ArmsandInterventions">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="ArmsandInterventions"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ArmsandInterventionsImg" class="toggleImage"
|
|
onclick="toggleModule('ArmsandInterventions');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Arms and Interventions</legend>
|
|
<div id="ArmsandInterventionsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td colspan="2">
|
|
<table class="ArmsInterv">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:60%;">Arms</th>
|
|
<th>Assigned Interventions</th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr style="border:1px solid gray">
|
|
<td>Experimental: 2<div class="indent1">pimavanserin tartrate (ACP-103) 20 mg, tablet,
|
|
once daily by mouth, 6 weeks</div>
|
|
</td>
|
|
<td>Drug: Pimavanserin tartrate (ACP-103)<div class="indent1">20 mg, tablet, once daily
|
|
by mouth, for six weeks</div>
|
|
</td>
|
|
</tr>
|
|
<tr style="border:1px solid gray">
|
|
<td>Placebo Comparator: <span class="drop_hilite">3</span> <span
|
|
class="add_hilite">Placebo</span>
|
|
<div class="indent1">Placebo tablet, once daily by mouth, 6 weeks</div>
|
|
</td>
|
|
<td>Drug: Pimavanserin tartrate (ACP-103)<div class="indent1">Placebo, tablet, once
|
|
daily by mouth, for six weeks</div>
|
|
</td>
|
|
</tr>
|
|
<tr style="border:1px solid gray">
|
|
<td>Experimental: 1<div class="indent1">pimavanserin tartrate (ACP-103) 10 mg, tablet,
|
|
once daily by mouth, 6 weeks</div>
|
|
</td>
|
|
<td>Drug: Pimavanserin tartrate (ACP-103)<div class="indent1">10 mg, tablet, once daily
|
|
by mouth, for six weeks</div>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_ProtocolOutcomeMeasures">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="ProtocolOutcomeMeasures"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ProtocolOutcomeMeasuresImg" class="toggleImage"
|
|
onclick="toggleModule('ProtocolOutcomeMeasures');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Outcome Measures</legend>
|
|
<div id="ProtocolOutcomeMeasuresBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:3em;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr><a href="#ROutcomeMeasures" class="indent1" style="white-space:nowrap;"
|
|
title="See Results Section Outcome Measures"> <span class="add_hilite">[See Results
|
|
Section.]</span></a>
|
|
<tr>
|
|
<td class="rowLabel" style="white-space:nowrap;width: 3em;">Primary Outcome Measures:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">1.</td>
|
|
<td><span class="drop_hilite">Antipsychotic efficacy will be assessed using the scale for the
|
|
assessment of Positive Symptoms (SAPS)</span> <span class="add_hilite">Antipsychotic
|
|
Efficacy</span><br>[ Time Frame: <span class="drop_hilite">6 weeks</span> <span
|
|
class="add_hilite">Each study visit (i.e. Days 1, 8, 15, 29 and 42)</span> ]<br><br>
|
|
<p><span class="add_hilite">Antipsychotic efficacy was defined as a decrease in the severity
|
|
and/or frequency of hallucinations and/or delusions. This is measured as the change from
|
|
baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms -
|
|
Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The
|
|
possible total score is 1 to 100 and a negative change in score indicates improvement.
|
|
</span></p>
|
|
|
|
<p><span class="add_hilite">Analysis Method: Analysis of Covariance (ANCOVA) and missing data
|
|
was imputed using Last Observation Carried Forward (LOCF) method.
|
|
</span>
|
|
</p>
|
|
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="white-space:nowrap;width: 3em;">Secondary Outcome Measures:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;"> <span class="add_hilite">1</span>.
|
|
</td>
|
|
<td> <span class="add_hilite">Motor Symptoms Change From Baseline (Negative =
|
|
Improvement)</span><br>[ Time Frame: <span class="add_hilite">Each study visit (i.e. Days 1,
|
|
8, 15, 29 and 42)</span> ]<br><br>
|
|
<p><span class="add_hilite">Motor symptoms were measured using the change from baseline (Day
|
|
1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale
|
|
(UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The total
|
|
possible score is 0 to 160 and a negative change in score indicates improvement.
|
|
</span></p>
|
|
|
|
<p><span class="add_hilite">Analysis Method: ANCOVA, and missing data was imputed using LOCF
|
|
method. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence
|
|
intervals (CIs) on the difference between each pimavanserin dose group and placebo mean
|
|
change from baseline. Non-inferiority was concluded if the upper limit of the CI was less
|
|
than or equal to 5.
|
|
</span></p>
|
|
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_Eligibility">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="Eligibility"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="EligibilityImg" class="toggleImage"
|
|
onclick="toggleModule('Eligibility');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Eligibility</legend>
|
|
<div id="EligibilityBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Minimum Age:</td>
|
|
<td>40 Years </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Maximum Age:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Sex:</td>
|
|
<td>All </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Gender Based:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Accepts Healthy Volunteers:</td>
|
|
<td>No</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Criteria:</td>
|
|
<td>
|
|
<p>Inclusion Criteria:</p>
|
|
<ul>
|
|
<li>A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year</li>
|
|
<li>Presence of visual and/or auditory hallucinations, and/or delusions, occurring during
|
|
the four weeks prior to study screening</li>
|
|
<li>Psychotic symptoms must have developed after Parkinson's disease diagnosis was
|
|
established</li>
|
|
<li>Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to
|
|
Study Day 1 (Baseline) and during the trial</li>
|
|
<li>Subject that has received stereotaxic surgery for subthalamic nucleus deep brain
|
|
stimulation must be at least 6 months post surgery and the stimulator settings must have
|
|
been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable
|
|
during the trial</li>
|
|
<li>The subject is willing and able to provide consent</li>
|
|
<li>Caregiver is willing and able to accompany the subject to all visits</li>
|
|
</ul>
|
|
<p>Exclusion Criteria:</p>
|
|
<ul>
|
|
<li>Subject has a history of significant psychotic disorders prior to or concomitantly with
|
|
the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or
|
|
bipolar disorder</li>
|
|
<li>Subject has received previous ablative stereotaxic surgery ( <span
|
|
class="drop_hilite">is</span> <span class="add_hilite">i</span>.<span
|
|
class="add_hilite">e.</span>, pallidotomy and thalamotomy) to treat Parkinson's
|
|
disease</li>
|
|
<li>Subject has current evidence of a serious and or unstable cardiovascular, respiratory,
|
|
gastrointestinal, renal, <span class="drop_hilite">mematologic </span> <span
|
|
class="add_hilite">hematologic </span>or other medical disorder</li>
|
|
<li>Subject has had a myocardial infarction in last six months</li>
|
|
<li>Subject has any surgery planned during the screening, treatment or follow-up periods
|
|
</li>
|
|
</ul>
|
|
<p>Patients will be evaluated at screening to ensure that all criteria for study participation
|
|
are met. These evaluations will include specific measures of psychosis severity, delirium,
|
|
dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the
|
|
study based on these assessments (and specifically if it is determined that their baseline
|
|
health and psychiatric condition do not meet all protocol-specified entry criteria).</p>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_ContactsLocations">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="ContactsLocations"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ContactsLocationsImg" class="toggleImage"
|
|
onclick="toggleModule('ContactsLocations');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Contacts/Locations</legend>
|
|
<div id="ContactsLocationsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Central Contact Person:</td>
|
|
<td><span class="drop_hilite">Kimberly Wilson<br><span class="indent1">Email:
|
|
ACP-103clintrials@acadia-pharm.com</span></span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Locations:</td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
California</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">
|
|
</td>
|
|
<td> <span class="add_hilite"><span class="indent1">La Habra, California, United States,
|
|
90631</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Laguna Hills, California, United States,
|
|
92653</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span class="drop_hilite"><span style="font-weight:bold;">United States,
|
|
California</span></span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="drop_hilite">[Recruiting]<br></span> <span class="indent1">Reseda, California,
|
|
United States</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Ventura, California, United States,
|
|
93003</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Colorado</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Englewood, Colorado, United States,
|
|
80113</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Connecticut</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Farmington, Connecticut, United States,
|
|
06030</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Florida</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Deerfield Beach, Florida, United States,
|
|
33064</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Panama City, Florida, United States,
|
|
32405</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Sarasota, Florida, United States,
|
|
34233</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Massachusetts</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Boston, Massachusetts, United States,
|
|
02215</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Worcester, Massachusetts, United States,
|
|
01655</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Michigan</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Clinton, Michigan, United States,
|
|
48035</span>
|
|
</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Detroit, Michigan, United States,
|
|
48201</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">East Lansing, Michigan, United States,
|
|
48824</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Missouri</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Columbia, Missouri, United States,
|
|
65201</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Nebraska</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Omaha, Nebraska, United States,
|
|
68131</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, New
|
|
York</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Albany, New York, United States,
|
|
12208</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Commack, New York, United States,
|
|
11725</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, North
|
|
Carolina</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Charlotte, North Carolina, United States,
|
|
28204</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Durham, North Carolina, United States,
|
|
27705</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span class="drop_hilite"><span style="font-weight:bold;">United States, North
|
|
Carolina</span></span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="drop_hilite">[Recruiting]<br></span> <span class="indent1">New Bern, North
|
|
Carolina, United States</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Ohio</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Toledo, Ohio, United States,
|
|
43614</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Pennsylvania</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Philadelphia, Pennsylvania, United States,
|
|
19131</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Philadelphia, Pennsylvania, United States,
|
|
19141</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Texas</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Houston, Texas, United States,
|
|
77030</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Vermont</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Burlington, Vermont, United States,
|
|
05401</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Austria</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Innsbruck, Austria, 6020</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Belgium</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Brussels, Belgium, 1090</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Ottignies, Belgium, 1340</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Roeselare, Belgium, 8800</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Chieti Scalo, Italy, 66013</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Grossetto, Italy, 58100</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Roma, Italy, 00163</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Roma, Italy, 00185</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Poland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Bydgoszcz, Poland, 85-096</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Katowice, Poland, 40-752</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Lodz, Poland, 90-130</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Lublin, Poland, 20-090</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Portugal</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Coimbra, Portugal, 3000-548</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Lisboa, Portugal, 1649-028</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Porto, Portugal, 4099-001</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Serbia</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Belgrade, Serbia, 11000</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Barcelona, Spain, 08003</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Barcelona, Spain, 08036</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Barcelona, Spain, 08195</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">San Sebastian, Spain, 20009</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Santiago De Compostela, Spain,
|
|
15706</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Sweden</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Jonkoping, Sweden, SE-551 85</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Linkoping, Sweden, SE-581 85</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span class="indent1">Stockholm, Sweden, SE-112 45</span></span>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_IPDSharing">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="IPDSharing"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="IPDSharingImg" class="toggleImage"
|
|
onclick="toggleModule('IPDSharing');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
IPDSharing</legend>
|
|
<div id="IPDSharingBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Plan to Share IPD:</td>
|
|
<td> <span class="add_hilite">No</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_References">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="References"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ReferencesImg" class="toggleImage"
|
|
onclick="toggleModule('References');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
References</legend>
|
|
<div id="ReferencesBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Citations:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Links:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Available IPD/Information:</td>
|
|
<td></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="3"><a id="Results"></a>
|
|
<div class="sectionDivider">Study Results</div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_ParticipantFlow"><a id="ParticipantFlow"></a>
|
|
<div>
|
|
<fieldset class="entryReq"
|
|
style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;background-color:#F7F7F7;">
|
|
<legend class="moduleLabel"> <img id="ParticipantFlowImg" class="toggleImage"
|
|
onclick="toggleModule('ParticipantFlow');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Participant Flow</legend>
|
|
<div id="ParticipantFlowBody" class="moduleBody">
|
|
<table class="moduleTable resultTable" style="margin-top:0.5em;">
|
|
<thead>
|
|
<tr style="display:none;">
|
|
<th style="width:250px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight popFlowLabelCell" style="min-width: 250px;">Recruitment Details
|
|
</td>
|
|
<td class="resultValueCell" style="text-align:left;width:100%"></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight popFlowLabelCell" style="min-width: 250px;">Pre-assignment
|
|
Details</td>
|
|
<td class="resultValueCell" style="text-align:left;width:100%"></td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2" style="margin-top:1em;"> </td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2" style="padding:0;">
|
|
<table class="resultTable" style="margin-top:1em;width:100%;empty-cells:show;">
|
|
<tbody>
|
|
<tr>
|
|
<th class="resultLabelCellRight popFlowLabelCell" style="min-width:250px;">Arm/Group
|
|
Title</th>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:center;width:33%;"> <span
|
|
class="add_hilite">Placebo</span>
|
|
</td>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:center;width:33%;"> <span
|
|
class="add_hilite">Pimavanserin 10 mg</span>
|
|
</td>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:center;width:33%;"> <span
|
|
class="add_hilite">Pimavanserin 20 mg</span></td>
|
|
</tr>
|
|
<tr>
|
|
<th class="resultLabelCellRight popFlowLabelCell">Arm/Group Description</th>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:left; width:33%;"><span
|
|
class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</th>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:left; width:33%;"><span
|
|
class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</th>
|
|
<th class="resultLabelCell popFlowLabelCell" style="text-align:left; width:33%;"><span
|
|
class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</th>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="4">
|
|
<tr>
|
|
<td style="padding-top: 1em;" colspan="4">Period Title: <span style="font-weight:bold;"> <span
|
|
class="add_hilite">Overall Study</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight popFlowLabelCell popFlowLabelCompleted"> <span class="add_hilite">Started</span>
|
|
</td>
|
|
<td class="resultValueCell"> <span class="add_hilite">40</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">42</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">41</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight popFlowLabelCell popFlowLabelCompleted"> <span
|
|
class="add_hilite">Completed</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">32</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">35</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight popFlowLabelCell popFlowLabelCompleted"> <span class="add_hilite">Not
|
|
Completed</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">8</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">4</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">6</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight popFlowLabelCell"><span
|
|
style="margin-left:1em;opacity:50%;font-weight:bold;">Reason Not Completed</span></td>
|
|
<td class="resultValueCell"></td>
|
|
<td class="resultValueCell"></td>
|
|
<td class="resultValueCell"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight popFlowLabelCell" style="padding-left: 2em;"> <span class="add_hilite">Adverse
|
|
Event</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">5</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">2</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">3</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight popFlowLabelCell" style="padding-left: 2em;"> <span class="add_hilite">Voluntary
|
|
Withdrawal of Consent</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">2</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">2</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight popFlowLabelCell" style="padding-left: 2em;"> <span class="add_hilite">Physician
|
|
Decision</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">0</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight popFlowLabelCell" style="padding-left: 2em;"> <span class="add_hilite">At
|
|
Discretion of Sponsor</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell popFlowValueNotCompleted"> <span class="add_hilite">1</span></td>
|
|
</tr>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_BaselineCharacteristics"><a id="BaselineCharacteristics"></a>
|
|
<div>
|
|
<fieldset class="entryReq"
|
|
style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;background-color:#F7F7F7;">
|
|
<legend class="moduleLabel"> <img id="BaselineCharacteristicsImg" class="toggleImage"
|
|
onclick="toggleModule('BaselineCharacteristics');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Baseline Characteristics</legend>
|
|
<div id="BaselineCharacteristicsBody" class="moduleBody">
|
|
<table class="moduleTable resultTable" style="margin-top:0.5em;">
|
|
<thead>
|
|
<tr style="display:none;">
|
|
<th style="width:250px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td colspan="2" style="padding:0;">
|
|
<table class="resultTable" style="width:100%;empty-cells:show;">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:15%;"></th>
|
|
<th style="width:10%;"></th>
|
|
<th style="width:18%;"></th>
|
|
<th style="width:18%;"></th>
|
|
<th style="width:18%;"></th>
|
|
<th style="width:18%;"></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="resultLabelCellRight baselineLabelCell resultTopCell" style="min-width:350px;"
|
|
colspan="2">Arm/Group Title</td>
|
|
<td class="resultLabelCell baselineLabelCell resultTopCell" style="text-align:center;">
|
|
<span class="add_hilite">Placebo</span></td>
|
|
<td class="resultLabelCell baselineLabelCell resultTopCell" style="text-align:center;">
|
|
<span class="add_hilite">10 mg</span></td>
|
|
<td class="resultLabelCell baselineLabelCell resultTopCell" style="text-align:center;">
|
|
<span class="add_hilite">20 mg</span></td>
|
|
<td class="resultLabelCell baselineLabelCell resultTopCell" style="text-align:center;">
|
|
<span class="add_hilite">Total</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight baselineLabelCell resultBottomCell" colspan="2">Arm/Group
|
|
Description</td>
|
|
<td class="resultLabelCell baselineLabelCell resultBottomCell" style="text-align:left;">
|
|
<span class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultLabelCell baselineLabelCell resultBottomCell" style="text-align:left;">
|
|
<span class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by
|
|
mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultLabelCell baselineLabelCell resultBottomCell" style="text-align:left;">
|
|
<span class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by
|
|
mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultLabelCell baselineLabelCell resultBottomCell" style="text-align:left;">
|
|
<span class="add_hilite">Total of all reporting groups
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight baselineLabelCell resultTopCell" colspan="2">Overall Number
|
|
of Baseline <span class="add_hilite">Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell"> <span class="add_hilite">39</span></td>
|
|
<td class="baselineValueCell resultTopCell"> <span class="add_hilite">41</span></td>
|
|
<td class="baselineValueCell resultTopCell"> <span class="add_hilite">41</span></td>
|
|
<td class="baselineValueCell resultTopCell"> <span class="add_hilite">121</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2" class=" resultLabelCellRight baselineLabelCell resultBottomCell">Baseline
|
|
Analysis Population Description</td>
|
|
<td colspan="4" class="resultValueCellLeft baselineValueCell resultBottomCell">
|
|
[Not Specified]</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell baselineLabelCell resultTopCell resultBottomCell" rowspan="4">
|
|
<span style="font-weight:bold;"> <span class="add_hilite">Age, Categorical</span></span>
|
|
<div style="font-size:smaller;padding-left:1em;margin-top:0.5em;">Measure Type: <span
|
|
class="add_hilite">Count of Participants</span><br>Unit of measure: <span
|
|
class="add_hilite">Participants</span></div>
|
|
</td>
|
|
<td class="resultLabelCellRight baselineLabelCell resultTopCell" style="font-size:smaller;">
|
|
Number Analyzed</td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">39 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">41 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">41 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">121 Participants</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight baselineLabelCell" style="font-size:smaller;"> <span
|
|
class="add_hilite"><=18 years</span></td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">0</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">0%</span></div>
|
|
</td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">0</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">0%</span></div>
|
|
</td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">0</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">0%</span></div>
|
|
</td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">0</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">0%</span></div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight baselineLabelCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">Between 18 and 65 years</span></td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">7</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">17.95%</span></div>
|
|
</td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">7</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">17.07%</span></div>
|
|
</td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">7</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">17.07%</span></div>
|
|
</td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">21</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">17.36%</span></div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight baselineLabelCell resultBottomCell"
|
|
style="font-size:smaller;"> <span class="add_hilite">>=65 years</span></td>
|
|
<td class="resultValueCell resultBottomCell">
|
|
<div class="percentHalf"> <span class="add_hilite">32</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">82.05%</span></div>
|
|
</td>
|
|
<td class="resultValueCell resultBottomCell">
|
|
<div class="percentHalf"> <span class="add_hilite">34</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">82.93%</span></div>
|
|
</td>
|
|
<td class="resultValueCell resultBottomCell">
|
|
<div class="percentHalf"> <span class="add_hilite">34</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">82.93%</span></div>
|
|
</td>
|
|
<td class="resultValueCell resultBottomCell">
|
|
<div class="percentHalf"> <span class="add_hilite">100</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">82.64%</span></div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell baselineLabelCell resultTopCell resultBottomCell" rowspan="2">
|
|
<span style="font-weight:bold;"> <span class="add_hilite">Age, Continuous</span></span>
|
|
<div style="font-size:smaller;padding-left:1em;margin-top:0.5em;"> <span
|
|
class="add_hilite">Mean</span> ( <span class="add_hilite">Standard
|
|
Deviation</span>)<br>Unit of measure: <span class="add_hilite">years</span></div>
|
|
</td>
|
|
<td class="resultLabelCellRight baselineLabelCell resultTopCell" style="font-size:smaller;">
|
|
Number Analyzed</td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">39 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">41 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">41 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">121 Participants</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight baselineLabelCell resultBottomCell"
|
|
style="font-size:smaller;"></td>
|
|
<td class="resultValueCell resultBottomCell"> <span class="add_hilite">73.0</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(7.91)</span></span></td>
|
|
<td class="resultValueCell resultBottomCell"> <span class="add_hilite">71.0</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(7.44)</span></span></td>
|
|
<td class="resultValueCell resultBottomCell"> <span class="add_hilite">72.1</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(8.15)</span></span></td>
|
|
<td class="resultValueCell resultBottomCell"> <span class="add_hilite">72.0</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(7.82)</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell baselineLabelCell resultTopCell resultBottomCell" rowspan="3">
|
|
<span style="font-weight:bold;"> <span class="add_hilite">Sex: Female, Male</span></span>
|
|
<div style="font-size:smaller;padding-left:1em;margin-top:0.5em;">Measure Type: <span
|
|
class="add_hilite">Count of Participants</span><br>Unit of measure: <span
|
|
class="add_hilite">Participants</span></div>
|
|
</td>
|
|
<td class="resultLabelCellRight baselineLabelCell resultTopCell" style="font-size:smaller;">
|
|
Number Analyzed</td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">39 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">41 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">41 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">121 Participants</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight baselineLabelCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">Female</span></td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">12</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">30.77%</span></div>
|
|
</td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">15</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">36.59%</span></div>
|
|
</td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">17</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">41.46%</span></div>
|
|
</td>
|
|
<td class="resultValueCell">
|
|
<div class="percentHalf"> <span class="add_hilite">44</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">36.36%</span></div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight baselineLabelCell resultBottomCell"
|
|
style="font-size:smaller;"> <span class="add_hilite">Male</span></td>
|
|
<td class="resultValueCell resultBottomCell">
|
|
<div class="percentHalf"> <span class="add_hilite">27</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">69.23%</span></div>
|
|
</td>
|
|
<td class="resultValueCell resultBottomCell">
|
|
<div class="percentHalf"> <span class="add_hilite">26</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">63.41%</span></div>
|
|
</td>
|
|
<td class="resultValueCell resultBottomCell">
|
|
<div class="percentHalf"> <span class="add_hilite">24</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">58.54%</span></div>
|
|
</td>
|
|
<td class="resultValueCell resultBottomCell">
|
|
<div class="percentHalf"> <span class="add_hilite">77</span></div>
|
|
<div class="percentHalf percentValue"> <span class="add_hilite">63.64%</span></div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell baselineLabelCell resultTopCell" rowspan="1"><span
|
|
style="font-weight:bold;"> <span class="add_hilite">Region of Enrollment</span></span>
|
|
<div style="font-size:smaller;padding-left:1em;margin-top:0.5em;">Measure Type: <span
|
|
class="add_hilite">Number</span><br>Unit of measure: <span
|
|
class="add_hilite">participants</span></div>
|
|
</td>
|
|
<td class="resultLabelCellRight baselineLabelCell resultTopCell" style="font-size:smaller;">
|
|
Number Analyzed</td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">39 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">41 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">41 Participants</span></td>
|
|
<td class="baselineValueCell resultTopCell" style="font-size:smaller;"> <span
|
|
class="add_hilite">121 Participants</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell baselineLabelCell">
|
|
<div style="text-align:right"> <span class="add_hilite">United States</span></div>
|
|
</td>
|
|
<td class="resultLabelCellRight baselineLabelCell" style="font-size:smaller;"></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">18</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">17</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">18</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">53</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell baselineLabelCell resultBottomCell">
|
|
<div style="text-align:right"> <span class="add_hilite">Europe</span></div>
|
|
</td>
|
|
<td class="resultLabelCellRight baselineLabelCell resultBottomCell"
|
|
style="font-size:smaller;"></td>
|
|
<td class="resultValueCell resultBottomCell"> <span class="add_hilite">21</span></td>
|
|
<td class="resultValueCell resultBottomCell"> <span class="add_hilite">24</span></td>
|
|
<td class="resultValueCell resultBottomCell"> <span class="add_hilite">23</span></td>
|
|
<td class="resultValueCell resultBottomCell"> <span class="add_hilite">68</span></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_ROutcomeMeasures"><a id="ROutcomeMeasures"></a>
|
|
<div>
|
|
<fieldset class="entryReq"
|
|
style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;background-color:#F7F7F7;">
|
|
<legend class="moduleLabel"> <img id="ROutcomeMeasuresImg" class="toggleImage"
|
|
onclick="toggleModule('ROutcomeMeasures');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Outcome Measures</legend>
|
|
<div id="ROutcomeMeasuresBody" class="moduleBody">
|
|
<table class="moduleTable resultTable" style="margin-top:0.5em;">
|
|
<thead>
|
|
<tr style="display:none;">
|
|
<th style="width:250px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td colspan="2">
|
|
<fieldset class="resultOMFieldset">
|
|
<legend class="resultOMLegend"> <span class="add_hilite">1. Primary</span> Outcome:</legend>
|
|
<div style="padding:1em;overflow-x:auto;background-color:#FFFFFF;">
|
|
<table class="moduleTable resultTable" style="width:100%;">
|
|
<thead>
|
|
<tr style="display:none;">
|
|
<th style="width:250px;"></th>
|
|
<th style="width:100%;"></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Title</td>
|
|
<td class="resultCell" style="width:100%"> <span class="add_hilite">Antipsychotic
|
|
Efficacy</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Description
|
|
</td>
|
|
<td class="resultValueCellLeft" style="text-align:left;width:100%">
|
|
<p><span class="add_hilite">Antipsychotic efficacy was defined as a decrease in the
|
|
severity and/or frequency of hallucinations and/or delusions. This is measured as
|
|
the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of
|
|
Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the
|
|
ITT Analysis Set. The possible total score is 1 to 100 and a negative change in
|
|
score indicates improvement.
|
|
</span></p>
|
|
|
|
<p><span class="add_hilite">Analysis Method: Analysis of Covariance (ANCOVA) and
|
|
missing data was imputed using Last Observation Carried Forward (LOCF) method.
|
|
</span></p>
|
|
|
|
</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Time Frame
|
|
</td>
|
|
<td class="resultValueCellLeft" style="text-align:left;width:100%"> <span
|
|
class="add_hilite">Each study visit (i.e. Days 1, 8, 15, 29 and 42)</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td style="padding:1em 0;" colspan="2">Outcome Measure Data</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell outcomeLabelCell" colspan="2">Analysis Population Description
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultCell" colspan="2"><span class="add_hilite">This is the "Intent to
|
|
Treat" population, defined as patients who received at least one dose of study
|
|
drug and had both the baseline SAPS assessment and at least one post-baseline SAPS
|
|
assessment.
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2" style="padding:0;">
|
|
<div class="BigTableWrapper">
|
|
<table class="resultTable" style="margin-top:1em;empty-cells:show;width:99.9%;">
|
|
<thead>
|
|
<tr style="visibility:hidden;">
|
|
<th class="resultLabelCell" style="width:15%;max-width:250px;border-width:0;">
|
|
</th>
|
|
<th></th>
|
|
<th></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width:250px"
|
|
colspan="1">Arm/Group Title</td>
|
|
<td class="resultLabelCell outcomeLabelCell"
|
|
style="text-align:center;width:25%;"> <span
|
|
class="add_hilite">Placebo</span></td>
|
|
<td class="resultLabelCell outcomeLabelCell"
|
|
style="text-align:center;width:25%;"> <span class="add_hilite">Pimavanserin
|
|
10 mg</span></td>
|
|
<td class="resultLabelCell outcomeLabelCell"
|
|
style="text-align:center;width:25%;"> <span class="add_hilite">Pimavanserin
|
|
20 mg</span></td>
|
|
<tr>
|
|
<td class="resultLabelCellRight outcomeLabelCell" colspan="1">Arm/Group
|
|
Description</td>
|
|
<td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span
|
|
class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span
|
|
class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once
|
|
daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span
|
|
class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once
|
|
daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight outcomeLabelCell" colspan="1">Overall Number
|
|
of Participants Analyzed</td>
|
|
<td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">41</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight outcomeLabelCell" rowspan="1">
|
|
<div style="font-size:smaller;"> <span class="add_hilite">Least Squares Mean
|
|
(95% Confidence Interval)</span><br>Unit of Measure: <span
|
|
class="add_hilite">Scores on the SAPS H+D scale</span></div>
|
|
</td>
|
|
<td class="resultValueCell"></td>
|
|
<td class="resultValueCell"></td>
|
|
<td class="resultValueCell"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell outcomeLabelCell">
|
|
<div style="text-align:right"> <span class="add_hilite">Change from
|
|
Baseline</span></div>
|
|
</td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-4.4</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(-6.5 to
|
|
-2.3)</span></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup
|
|
class="commentOutcomeIndex"> [1]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-6.5</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(-8.5 to
|
|
-4.5)</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell outcomeLabelCell">
|
|
<div style="text-align:right"> <span class="add_hilite">Difference of Least
|
|
Squares Mean versus Placebo</span></div>
|
|
</td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup
|
|
class="commentOutcomeIndex"> [2]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup
|
|
class="commentOutcomeIndex"> [1]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-2.1</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(-4.9 to
|
|
0.8)</span></span></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="4">
|
|
<table style="border-collapse:collapse;border-width:0;table-layout:fixed;width:100%;">
|
|
<tbody>
|
|
<tr>
|
|
<td style="width:3em;text-align:center;vertical-align:text-top;"><span
|
|
class="commentOutcomeIndex">[1]</span></td>
|
|
<td style="text-align:left;"> <span class="add_hilite">NA
|
|
Explanation: </span><span class="add_hilite">Only the high dose
|
|
comparison was incorporated in the ANCOVA model analysis following the early
|
|
termination of the study. The prospective SAP eliminated the analysis of the
|
|
low dose, 10 mg arm.
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td style="width:3em;text-align:center;vertical-align:text-top;"><span
|
|
class="commentOutcomeIndex">[2]</span></td>
|
|
<td style="text-align:left;"> <span class="add_hilite">NA
|
|
Explanation: </span><span class="add_hilite">Calculation is a
|
|
comparison of active arm versus placebo.
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<fieldset class="resultOMFieldset">
|
|
<legend class="resultOMLegend"> <span class="add_hilite">2. Secondary</span> Outcome:</legend>
|
|
<div style="padding:1em;overflow-x:auto;background-color:#FFFFFF;">
|
|
<table class="moduleTable resultTable" style="width:100%;">
|
|
<thead>
|
|
<tr style="display:none;">
|
|
<th style="width:250px;"></th>
|
|
<th style="width:100%;"></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Title</td>
|
|
<td class="resultCell" style="width:100%"> <span class="add_hilite">Motor Symptoms
|
|
Change From Baseline (Negative = Improvement)</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Description
|
|
</td>
|
|
<td class="resultValueCellLeft" style="text-align:left;width:100%">
|
|
<p><span class="add_hilite">Motor symptoms were measured using the change from
|
|
baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's
|
|
Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III
|
|
(Motor Examination). The total possible score is 0 to 160 and a negative change in
|
|
score indicates improvement.
|
|
</span></p>
|
|
|
|
<p><span class="add_hilite">Analysis Method: ANCOVA, and missing data was imputed
|
|
using LOCF method. The UPDRS Parts II+III score was analyzed by constructing
|
|
2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin
|
|
dose group and placebo mean change from baseline. Non-inferiority was concluded if
|
|
the upper limit of the CI was less than or equal to 5.
|
|
</span></p>
|
|
|
|
</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width: 250px;">Time Frame
|
|
</td>
|
|
<td class="resultValueCellLeft" style="text-align:left;width:100%"> <span
|
|
class="add_hilite">Each study visit (i.e. Days 1, 8, 15, 29 and 42)</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td style="padding:1em 0;" colspan="2">Outcome Measure Data</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell outcomeLabelCell" colspan="2">Analysis Population Description
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultCell" colspan="2"><span class="add_hilite">This is the "Intent to
|
|
Treat" population, defined as patients who received at least one dose of study
|
|
drug and had both the baseline SAPS assessment and at least one post-baseline SAPS
|
|
assessment.
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2" style="padding:0;">
|
|
<div class="BigTableWrapper">
|
|
<table class="resultTable" style="margin-top:1em;empty-cells:show;width:99.9%;">
|
|
<thead>
|
|
<tr style="visibility:hidden;">
|
|
<th class="resultLabelCell" style="width:15%;max-width:250px;border-width:0;">
|
|
</th>
|
|
<th></th>
|
|
<th></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="resultLabelCellRight outcomeLabelCell" style="min-width:250px"
|
|
colspan="1">Arm/Group Title</td>
|
|
<td class="resultLabelCell outcomeLabelCell"
|
|
style="text-align:center;width:25%;"> <span
|
|
class="add_hilite">Placebo</span></td>
|
|
<td class="resultLabelCell outcomeLabelCell"
|
|
style="text-align:center;width:25%;"> <span class="add_hilite">Pimavanserin
|
|
10 mg</span></td>
|
|
<td class="resultLabelCell outcomeLabelCell"
|
|
style="text-align:center;width:25%;"> <span class="add_hilite">Pimavanserin
|
|
20 mg</span></td>
|
|
<tr>
|
|
<td class="resultLabelCellRight outcomeLabelCell" colspan="1">Arm/Group
|
|
Description</td>
|
|
<td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span
|
|
class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span
|
|
class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once
|
|
daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultLabelCell outcomeLabelCell" style="text-align:left;"><span
|
|
class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once
|
|
daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight outcomeLabelCell" colspan="1">Overall Number
|
|
of Participants Analyzed</td>
|
|
<td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">38</span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">41</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight outcomeLabelCell" rowspan="1">
|
|
<div style="font-size:smaller;"> <span class="add_hilite">Least Squares Mean
|
|
(95% Confidence Interval)</span><br>Unit of Measure: <span
|
|
class="add_hilite">Score on UPDRS-II+III scale.</span></div>
|
|
</td>
|
|
<td class="resultValueCell"></td>
|
|
<td class="resultValueCell"></td>
|
|
<td class="resultValueCell"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell outcomeLabelCell">
|
|
<div style="text-align:right"> <span class="add_hilite">Change from
|
|
Baseline</span></div>
|
|
</td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-1.8</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(-4.6 to
|
|
1.0)</span></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup
|
|
class="commentOutcomeIndex"> [1]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-3.9</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(-6.6 to
|
|
-1.2)</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell outcomeLabelCell">
|
|
<div style="text-align:right"> <span class="add_hilite">Difference of Least
|
|
Squares Mean versus Placebo</span></div>
|
|
</td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup
|
|
class="commentOutcomeIndex"> [2]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">NA</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(NA to NA)</span><sup
|
|
class="commentOutcomeIndex"> [1]</sup></span></td>
|
|
<td class="resultValueCell"> <span class="add_hilite">-2.1</span> <span
|
|
class="add_hilite"><span style="margin-left:0.5em;">(-5.9 to
|
|
1.8)</span></span></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="4">
|
|
<table style="border-collapse:collapse;border-width:0;table-layout:fixed;width:100%;">
|
|
<tbody>
|
|
<tr>
|
|
<td style="width:3em;text-align:center;vertical-align:text-top;"><span
|
|
class="commentOutcomeIndex">[1]</span></td>
|
|
<td style="text-align:left;"> <span class="add_hilite">NA
|
|
Explanation: </span><span class="add_hilite">Only the high dose
|
|
comparison was incorporated in the ANCOVA model analysis following the early
|
|
termination of the study. The prospective SAP eliminated the analysis of the
|
|
low dose, 10 mg arm.
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td style="width:3em;text-align:center;vertical-align:text-top;"><span
|
|
class="commentOutcomeIndex">[2]</span></td>
|
|
<td style="text-align:left;"> <span class="add_hilite">NA
|
|
Explanation: </span><span class="add_hilite">Calculation is a
|
|
comparison of active arm versus placebo.
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_AdverseEvents"><a id="AdverseEvents"></a>
|
|
<div>
|
|
<fieldset class="entryReq"
|
|
style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;background-color:#F7F7F7;">
|
|
<legend class="moduleLabel"> <img id="AdverseEventsImg" class="toggleImage"
|
|
onclick="toggleModule('AdverseEvents');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Adverse Events</legend>
|
|
<div id="AdverseEventsBody" class="moduleBody">
|
|
<table class="moduleTable resultTable" style="margin-top:0.5em;">
|
|
<thead>
|
|
<tr style="display:none;">
|
|
<th style="width:250px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td colspan=2 style="padding:0;">
|
|
<table class="resultTable" style="width:100%;">
|
|
<thead style="display:none;">
|
|
<tr>
|
|
<th class="resultLabelCell labelCellAdEv"> </th>
|
|
<th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:16%"></th>
|
|
<th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:8%"></th>
|
|
<th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:16%"></th>
|
|
<th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:8%"></th>
|
|
<th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:16%"></th>
|
|
<th class="resultLabelCell labelCellAdEv resultBottomCell" style="width:8%"></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell" style="min-width: 300px;">Time
|
|
Frame</td>
|
|
<td class="resultValueCellLeft resultTopCell" colspan="6"> <span class="add_hilite">6
|
|
weeks</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultBottomCell" style="min-width: 25%;">
|
|
Adverse Event Reporting Description</td>
|
|
<td class="resultValueCell resultBottomCell" style="text-align:left;" colspan="6"><span
|
|
class="add_hilite">From the time the informed consent was signed, adverse events were
|
|
recorded in the subject's source documents and entered into the appropriate eCRF
|
|
pages at the Screening visit, at visits on Study Days 1, 8, 15, 29, 42 and Day 70 or 4
|
|
weeks after the last dose for subjects who do not continue into the open-label,
|
|
extension protocol.
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="7" style="padding-top:1em;border-width:0;"> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell">Arm/Group Title</td>
|
|
<td class="resultValueCell resultTopCell" style="text-align:center;" colspan="2"> <span
|
|
class="add_hilite">Placebo</span></td>
|
|
<td class="resultValueCell resultTopCell" style="text-align:center;" colspan="2"> <span
|
|
class="add_hilite">Pimavanserin 10 mg</span></td>
|
|
<td class="resultValueCell resultTopCell" style="text-align:center;" colspan="2"> <span
|
|
class="add_hilite">Pimavanserin 20 mg</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCellRight labelCellAdEv resultBottomCell">Arm/Group Description</td>
|
|
<td class="resultValueCellLeft resultTopCell resultBottomCell" colspan="2"><span
|
|
class="add_hilite">Placebo tablet, once daily by mouth, 6 weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultValueCellLeft resultTopCell resultBottomCell" colspan="2"><span
|
|
class="add_hilite">Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6
|
|
weeks
|
|
</span>
|
|
</td>
|
|
<td class="resultValueCellLeft resultTopCell resultBottomCell" colspan="2"><span
|
|
class="add_hilite">Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6
|
|
weeks
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="7" style="padding-top:1em;font-weight:bold;">All-Cause Mortality</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell"> </td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;"
|
|
colspan="2"><span style="font-weight:bold;"> <span
|
|
class="add_hilite">Placebo</span></span></td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;"
|
|
colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 10
|
|
mg</span></span></td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;"
|
|
colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 20
|
|
mg</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"> </td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)
|
|
</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)
|
|
</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)
|
|
</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell resultBottomCell"
|
|
style="min-width: 250px;">Total</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> / </td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell"></td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> / </td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell"></td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> / </td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell"></td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="7" class="resultTopCell resultBottomCell"
|
|
style="padding-top:1em;font-weight:bold;">Serious Adverse Events</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell"> </td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;"
|
|
colspan="2"><span style="font-weight:bold;"> <span
|
|
class="add_hilite">Placebo</span></span></td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;"
|
|
colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 10
|
|
mg</span></span></td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;"
|
|
colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 20
|
|
mg</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"> </td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)
|
|
</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)
|
|
</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)
|
|
</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell resultBottomCell"
|
|
style="min-width: 250px;">Total</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span
|
|
class="add_hilite">2</span> / <span class="add_hilite">39</span> ( <span
|
|
class="add_hilite">5.13%</span>)</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell"></td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span
|
|
class="add_hilite">3</span> / <span class="add_hilite">41</span> ( <span
|
|
class="add_hilite">7.32%</span>)</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell"></td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span
|
|
class="add_hilite">1</span> / <span class="add_hilite">41</span> ( <span
|
|
class="add_hilite">2.44%</span>)</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span
|
|
class="add_hilite">Infections and infestations</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Gastroenteritis <sup class="commentAdEvIndex">† A </sup></span>
|
|
</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">2.56%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span
|
|
class="add_hilite">Injury, poisoning and procedural complications</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Fall <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Hip fracture <sup class="commentAdEvIndex">† A </sup></span>
|
|
</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span
|
|
class="add_hilite">Nervous system disorders</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Parkinson's disease <sup class="commentAdEvIndex">† A
|
|
</sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span
|
|
class="add_hilite">Psychiatric disorders</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Delirium <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">2.56%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Delusion <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Delusional disorder, persecutory type <sup
|
|
class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Mental status changes <sup class="commentAdEvIndex">† A
|
|
</sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">2.56%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="7"><span class="commentAdEvIndex"
|
|
style="font-weight:bold;margin-right:1em;">†</span> <span
|
|
class="add_hilite">Indicates events were collected by systematic assessment.</span><br>
|
|
<span class="add_hilite"><span class="commentAdEvIndex"
|
|
style="margin-right:1em;">A</span>Term from vocabulary, MedDRA (11.1)</span><br>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="7" class="resultTopCell resultBottomCell"
|
|
style="padding-top:1em;font-weight:bold;">Other (Not Including Serious) Adverse Events
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell resultBottomCell"
|
|
style="min-width: 250px;">Frequency Threshold for Reporting Other Adverse Events</td>
|
|
<td colspan="6" class="resultCell resultTopCell resultBottomCell"> <span
|
|
class="add_hilite">5.00</span>%</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell"> </td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;"
|
|
colspan="2"><span style="font-weight:bold;"> <span
|
|
class="add_hilite">Placebo</span></span></td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;"
|
|
colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 10
|
|
mg</span></span></td>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" style="text-align:center;"
|
|
colspan="2"><span style="font-weight:bold;"> <span class="add_hilite">Pimavanserin 20
|
|
mg</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"> </td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)
|
|
</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)
|
|
</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell" dataCellAdEv"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;">Affected / At Risk (%)
|
|
</td>
|
|
<td class="resultLabelCell labelCellAdEv resultBottomCell"
|
|
style="text-align:center;font-size:smaller;vertical-align:middle;"># Events</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv resultTopCell resultBottomCell"
|
|
style="min-width: 250px;">Total</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span
|
|
class="add_hilite">12</span> / <span class="add_hilite">39</span> ( <span
|
|
class="add_hilite">30.77%</span>)</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell"></td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span
|
|
class="add_hilite">4</span> / <span class="add_hilite">41</span> ( <span
|
|
class="add_hilite">9.76%</span>)</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell"></td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell dataCellAdEv"> <span
|
|
class="add_hilite">8</span> / <span class="add_hilite">41</span> ( <span
|
|
class="add_hilite">19.51%</span>)</td>
|
|
<td class="resultValueCell resultTopCell resultBottomCell"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span
|
|
class="add_hilite">Injury, poisoning and procedural complications</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Fall <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">7.69%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">5</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">4.88%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">7.32%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span
|
|
class="add_hilite">Nervous system disorders</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Dizziness <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">5.13%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Somnolence <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">5.13%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">2.44%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span
|
|
class="add_hilite">Psychiatric disorders</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Hallucination <sup class="commentAdEvIndex">† A </sup></span>
|
|
</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">5.13%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">4.88%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Insomnia <sup class="commentAdEvIndex">† A </sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">2.56%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">1</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">7.32%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="resultLabelCell labelCellAdEv resultTopCell" colspan="7"> <span
|
|
class="add_hilite">Vascular disorders</span></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="resultLabelCellRight labelCellAdEv" style="min-width: 250px;"> <span
|
|
class="add_hilite">Orthostatic hypotension <sup class="commentAdEvIndex">† A
|
|
</sup></span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span> / <span
|
|
class="add_hilite">39</span> ( <span class="add_hilite">7.69%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">3</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">4.88%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">2</span></td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span> / <span
|
|
class="add_hilite">41</span> ( <span class="add_hilite">0%</span>)</td>
|
|
<td class="resultValueCell dataCellAdEv"> <span class="add_hilite">0</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="7"><span class="commentAdEvIndex"
|
|
style="font-weight:bold;margin-right:1em;">†</span> <span
|
|
class="add_hilite">Indicates events were collected by systematic assessment.</span><br>
|
|
<span class="add_hilite"><span class="commentAdEvIndex"
|
|
style="margin-right:1em;">A</span>Term from vocabulary, MedDRA (11.1)</span><br>
|
|
</td>
|
|
</tr>
|
|
</table>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="3"><a id="LimitationsandCaveatsorMoreInformation"></a></td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_LimitationsandCaveats"><a id="LimitationsandCaveats"></a>
|
|
<div>
|
|
<fieldset class="entryReq" style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;">
|
|
<legend class="moduleLabel"> <img id="LimitationsandCaveatsImg" class="toggleImage"
|
|
onclick="toggleModule('LimitationsandCaveats');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Limitations and Caveats</legend>
|
|
<div id="LimitationsandCaveatsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr style="line-height: 0;">
|
|
<th style="width:10%;"></th>
|
|
<th style="width:90%;"></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td colspan="2">
|
|
<div class="indent1">[Not specified]</div>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan=3>
|
|
<form id="form_MoreInformation"><a id="MoreInformation"></a>
|
|
<div>
|
|
<fieldset class="entryReq" style="margin:auto;margin-bottom:1em;width:98%;padding-bottom:0.5em;">
|
|
<legend class="moduleLabel"> <img id="MoreInformationImg" class="toggleImage"
|
|
onclick="toggleModule('MoreInformation');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
More Information</legend>
|
|
<div id="MoreInformationBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr style="line-height: 0;">
|
|
<th style="width:20%;"></th>
|
|
<th style="width:80%;"></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td colspan="2"><span style="font-weight:bold;">Certain Agreements</span>:</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<div class="indent1" style="display:inline-block;"> <span class="add_hilite">Principal
|
|
Investigators are NOT employed by the organization sponsoring the study.<br /><br />There IS
|
|
an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts
|
|
the PI's rights to discuss or publish trial results after the trial is completed.
|
|
<br /><br /><span class="indent1"
|
|
style="display:inline-block;background-color:inherit">Investigator may publish the study
|
|
results, relative to his/her own patients, only after review, comment and approval by the
|
|
sponsor. No publication of confidential information shall be made without the sponsor's
|
|
prior written consent. At least 60 days prior to submitting a manuscript or prior to any
|
|
public presentation, a copy of the manuscript or presentation will be provided to the
|
|
sponsor for review and comment. The sponsor has 60 days to review and comment.</span></span>
|
|
</div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<div style="margin-top:1em;"><span style="font-weight:bold;">Results Point of Contact</span>:
|
|
</div>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">
|
|
<div class="indent1" style="text-align:left;">Name/Official Title:</div>
|
|
</td>
|
|
<td> <span class="add_hilite">Roger Mills, MD</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">
|
|
<div class="indent1" style="text-align:left;">Organization:</div>
|
|
</td>
|
|
<td> <span class="add_hilite">ACADIA Pharmaceuticals Inc.</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">
|
|
<div class="indent1" style="text-align:left;">Phone:</div>
|
|
</td>
|
|
<td> <span class="add_hilite">858-202-7563</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">
|
|
<div class="indent1" style="text-align:left;">Email:</div>
|
|
</td>
|
|
<td> <span class="add_hilite">rmills@acadia-pharm.com</span></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
<hr class="fancyDivider" style="margin:2px auto;">
|
|
<div style="padding-top:4px;padding-bottom:2px;text-align:center;font-size:smaller;color:grey;"><a href="javascript:;"
|
|
onClick="document.getElementById('controls').scrollIntoView();">Scroll up to access the controls</a>
|
|
<a href="javascript:;" style="float:right;margin-right:2em;"
|
|
onClick="document.getElementById('StudyPageTop').scrollIntoView();">Scroll to the Study top</a>
|
|
</div>
|
|
<hr class="fancyDivider" style="margin:4px 0;">
|
|
<div style="text-align:center;font-size:smaller;margin-top:10px;margin-bottom:10px;"><a
|
|
href="https://www.nlm.nih.gov/" title="U.S. National Library of Medicine">U.S. National Library of
|
|
Medicine</a> | <a href="https://www.nih.gov/" title="U.S. National Institutes of Health">U.S. National
|
|
Institutes of Health</a> | <a href="https://www.hhs.gov/"
|
|
title="U.S. Department of Health & Human Services">U.S. Department of Health & Human Services</a></div>
|
|
<script type="text/javascript">__ncbi_sg_gaMode = "clinicaltrials"</script>
|
|
<script type="text/javascript" src="/html/js/instrumentNCBIBaseJS.min.js?v=2"></script><noscript></noscript>
|
|
<script
|
|
type="text/javascript">function sendSearchPing() { var cVals = ncbi.sg.getInstance()._cachedVals; var app = cVals['ncbi_app']; var db = cVals['ncbi_db']; var pdid = cVals['ncbi_pdid']; var pcid = cVals['ncbi_pcid']; var searchDetails = {}; searchDetails['jsevent'] = 'search'; searchDetails['searchtext'] = jQuery('#header-search-query').val(); if (app != null) searchDetails['ncbi_app'] = app.value; if (db != null) searchDetails['ncbi_db'] = db.value; if (pdid != null) searchDetails['ncbi_pdid'] = pdid.value; if (pcid != null) searchDetails['ncbi_pcid'] = pcid.value; ncbi.sg.ping(searchDetails); };</script>
|
|
</body>
|
|
|
|
</html> |