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ClinicalTrials.gov +
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History of Changes for Study: NCT00658567
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A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
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Latest version (submitted April 18, 2017) on ClinicalTrials.gov
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VersionABSubmitted DateChanges
1April 10, 2008 +None (earliest Version on record)
2May 19, 2008 +Study Status and Contacts/Locations
3August 25, 2008 +Study Status and Contacts/Locations
4September 24, 2008 +Study Status and Contacts/Locations
5October 20, 2008 +Study Status and Contacts/Locations
6November 17, 2008 +Study Status and Contacts/Locations
7December 17, 2008 +Contacts/Locations, Study Status and Eligibility
8February 16, 2009 +Study Status and Contacts/Locations
9March 26, 2009 +Study Status and Contacts/Locations
10April 16, 2009 +Study Status and Contacts/Locations
11June 16, 2009 +Contacts/Locations and Study Status
12July 16, 2009 +Study Status and Contacts/Locations
13August 4, 2010 +Recruitment Status, Study Status, Contacts/Locations and Sponsor/Collaborators
14August 29, 2014 +Study Status, Outcome Measures, Sponsor/Collaborators, Arms and Interventions, Study Design, Results and Eligibility
15April 18, 2017 +Oversight, Study Status, IPDSharing and Contacts/Locations
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+Changes (Merged) for Study: NCT00658567
+April 10, 2008 (v1) -- April 18, 2017 (v15)

Changes in: Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing and Results +
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Unique Protocol ID:ACP-103-014
Brief Title:A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Official Title:
Secondary IDs:
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Record Verification:April 2008 2017
Overall Status:Recruiting Completed
Study Start:March 2008
Primary Completion: December 2009 [Actual]
Study Completion:December 2009 [ Anticipated Actual]
First Submitted:April 10, 2008
First Submitted that
Met QC Criteria:		April 10, 2008
First Posted:April 15, 2008 [Estimate]
Results First Submitted: February 6, 2014
Results First Submitted that
Met QC Criteria:		 August 29, 2014
Results First Posted: September 9, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:		April 10 18, 2008 2017
Last Update Posted:April 15, 2008 [Estimate] May 19, 2017 [Actual]
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Sponsor:ACADIA Pharmaceuticals Inc.
Responsible Party: Sponsor
Collaborators:
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U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
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Brief Summary: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.
Detailed Description:
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Conditions:Parkinson's Disease Psychosis
Keywords:
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Study Type:Interventional
Primary Purpose:Treatment
Study Phase:Phase 3
Interventional Study Model:Parallel Assignment
Number of Arms:3
Masking:Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:Randomized
Enrollment:240 [Anticipated] 123 [Actual]
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ArmsAssigned Interventions
Experimental: 2
pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
Drug: Pimavanserin tartrate (ACP-103)
20 mg, tablet, once daily by mouth, for six weeks
Placebo Comparator: 3 Placebo
Placebo tablet, once daily by mouth, 6 weeks
Drug: Pimavanserin tartrate (ACP-103)
Placebo, tablet, once daily by mouth, for six weeks
Experimental: 1
pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
Drug: Pimavanserin tartrate (ACP-103)
10 mg, tablet, once daily by mouth, for six weeks
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Primary Outcome Measures:
1.Antipsychotic efficacy will be assessed using the scale for the assessment of Positive Symptoms (SAPS) Antipsychotic Efficacy
[ Time Frame: 6 weeks Each study visit (i.e. Days 1, 8, 15, 29 and 42) ]

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. +

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Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method. +

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Secondary Outcome Measures:
1. Motor Symptoms Change From Baseline (Negative = Improvement)
[ Time Frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42) ]

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. +

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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. +

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Minimum Age:40 Years
Maximum Age:
Sex:All
Gender Based:
Accepts Healthy Volunteers:No
Criteria:

Inclusion Criteria:

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  • A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
  • Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
  • Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
  • Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
  • 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
  • The subject is willing and able to provide consent
  • Caregiver is willing and able to accompany the subject to all visits
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Exclusion Criteria:

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  • 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
  • Subject has received previous ablative stereotaxic surgery ( is i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
  • Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, mematologic hematologic or other medical disorder
  • Subject has had a myocardial infarction in last six months
  • Subject has any surgery planned during the screening, treatment or follow-up periods
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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).

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Central Contact Person:Kimberly Wilson
Email: ACP-103clintrials@acadia-pharm.com
Locations: United States, California
La Habra, California, United States, 90631
Laguna Hills, California, United States, 92653
United States, California
[Recruiting]
 Reseda, California, United States
Ventura, California, United States, 93003
United States, Colorado
Englewood, Colorado, United States, 80113
United States, Connecticut
Farmington, Connecticut, United States, 06030
United States, Florida
Deerfield Beach, Florida, United States, 33064
Panama City, Florida, United States, 32405
Sarasota, Florida, United States, 34233
United States, Massachusetts
Boston, Massachusetts, United States, 02215
Worcester, Massachusetts, United States, 01655
United States, Michigan
Clinton, Michigan, United States, 48035
Detroit, Michigan, United States, 48201
East Lansing, Michigan, United States, 48824
United States, Missouri
Columbia, Missouri, United States, 65201
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New York
Albany, New York, United States, 12208
Commack, New York, United States, 11725
United States, North Carolina
Charlotte, North Carolina, United States, 28204
Durham, North Carolina, United States, 27705
United States, North Carolina
[Recruiting]
 New Bern, North Carolina, United States
United States, Ohio
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19131
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
Houston, Texas, United States, 77030
United States, Vermont
Burlington, Vermont, United States, 05401
Austria
Innsbruck, Austria, 6020
Belgium
Brussels, Belgium, 1090
Ottignies, Belgium, 1340
Roeselare, Belgium, 8800
Italy
Chieti Scalo, Italy, 66013
Grossetto, Italy, 58100
Roma, Italy, 00163
Roma, Italy, 00185
Poland
Bydgoszcz, Poland, 85-096
Katowice, Poland, 40-752
Lodz, Poland, 90-130
Lublin, Poland, 20-090
Portugal
Coimbra, Portugal, 3000-548
Lisboa, Portugal, 1649-028
Porto, Portugal, 4099-001
Serbia
Belgrade, Serbia, 11000
Spain
Barcelona, Spain, 08003
Barcelona, Spain, 08036
Barcelona, Spain, 08195
San Sebastian, Spain, 20009
Santiago De Compostela, Spain, 15706
Sweden
Jonkoping, Sweden, SE-551 85
Linkoping, Sweden, SE-581 85
Stockholm, Sweden, SE-112 45
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Plan to Share IPD: No
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Citations:
Links:
Available IPD/Information:
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Study Results
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Recruitment Details
Pre-assignment Details
 
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Arm/Group Title Placebo + Pimavanserin 10 mg + Pimavanserin 20 mg +
Arm/Group DescriptionPlacebo tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks + +
Period Title: Overall Study
Started 40 42 41
Completed 32 38 35
Not Completed 8 4 6
Reason Not Completed
Adverse Event 5 2 3
Voluntary Withdrawal of Consent 2 0 2
Physician Decision 0 1 0
At Discretion of Sponsor 1 1 1
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Arm/Group Title Placebo 10 mg 20 mg Total
Arm/Group DescriptionPlacebo tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks + +Total of all reporting groups + +
Overall Number of Baseline Participants 39 41 41 121
Baseline Analysis Population Description +[Not Specified]
Age, Categorical
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed 39 Participants 41 Participants 41 Participants 121 Participants
<=18 years
0
0%
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Between 18 and 65 years
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17.95%
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17.07%
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17.07%
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17.36%
>=65 years
32
82.05%
34
82.93%
34
82.93%
100
82.64%
Age, Continuous
Mean ( Standard Deviation)
Unit of measure: years
Number Analyzed 39 Participants 41 Participants 41 Participants 121 Participants
73.0 (7.91) 71.0 (7.44) 72.1 (8.15) 72.0 (7.82)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed 39 Participants 41 Participants 41 Participants 121 Participants
Female
12
30.77%
15
36.59%
17
41.46%
44
36.36%
Male
27
69.23%
26
63.41%
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58.54%
77
63.64%
Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed 39 Participants 41 Participants 41 Participants 121 Participants
United States
 18 17 18 53
Europe
 21 24 23 68
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1. Primary Outcome:
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Title Antipsychotic Efficacy
Description

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. +

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Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method. +

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Time Frame Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Outcome Measure Data
Analysis Population Description
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. + +
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Arm/Group Title Placebo Pimavanserin 10 mg Pimavanserin 20 mg
Arm/Group DescriptionPlacebo tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks + +
Overall Number of Participants Analyzed 38 38 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Scores on the SAPS H+D scale
Change from Baseline
 -4.4 (-6.5 to -2.3) NA (NA to NA) [1] -6.5 (-8.5 to -4.5)
Difference of Least Squares Mean versus Placebo
 NA (NA to NA) [2] NA (NA to NA) [1] -2.1 (-4.9 to 0.8)
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[1] NA Explanation: 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. + +
[2] NA Explanation: Calculation is a comparison of active arm versus placebo. + +
2. Secondary Outcome:
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Title Motor Symptoms Change From Baseline (Negative = Improvement)
Description

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. +

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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. +

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Time Frame Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Outcome Measure Data
Analysis Population Description
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. + +
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Arm/Group Title Placebo Pimavanserin 10 mg Pimavanserin 20 mg
Arm/Group DescriptionPlacebo tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks + +
Overall Number of Participants Analyzed 38 38 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on UPDRS-II+III scale.
Change from Baseline
 -1.8 (-4.6 to 1.0) NA (NA to NA) [1] -3.9 (-6.6 to -1.2)
Difference of Least Squares Mean versus Placebo
 NA (NA to NA) [2] NA (NA to NA) [1] -2.1 (-5.9 to 1.8)
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[1] NA Explanation: 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. + +
[2] NA Explanation: Calculation is a comparison of active arm versus placebo. + +
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Time Frame 6 weeks
Adverse Event Reporting DescriptionFrom 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. + +
 
Arm/Group Title Placebo Pimavanserin 10 mg Pimavanserin 20 mg
Arm/Group DescriptionPlacebo tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks + +Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks + +
All-Cause Mortality
  Placebo Pimavanserin 10 mg Pimavanserin 20 mg
 Affected / At Risk (%)# EventsAffected / At Risk (%)# EventsAffected / At Risk (%)# Events
Total / / /
Serious Adverse Events
  Placebo Pimavanserin 10 mg Pimavanserin 20 mg
 Affected / At Risk (%)# EventsAffected / At Risk (%)# EventsAffected / At Risk (%)# Events
Total 2 / 39 ( 5.13%) 3 / 41 ( 7.32%) 1 / 41 ( 2.44%)
Infections and infestations
Gastroenteritis † A 1 / 39 ( 2.56%) 1 0 / 41 ( 0%) 0 0 / 41 ( 0%) 0
Injury, poisoning and procedural complications
Fall † A 0 / 39 ( 0%) 0 1 / 41 ( 2.44%) 1 0 / 41 ( 0%) 0
Hip fracture † A 0 / 39 ( 0%) 0 1 / 41 ( 2.44%) 1 0 / 41 ( 0%) 0
Nervous system disorders
Parkinson's disease † A 0 / 39 ( 0%) 0 0 / 41 ( 0%) 0 1 / 41 ( 2.44%) 1
Psychiatric disorders
Delirium † A 1 / 39 ( 2.56%) 1 0 / 41 ( 0%) 0 0 / 41 ( 0%) 0
Delusion † A 0 / 39 ( 0%) 0 1 / 41 ( 2.44%) 2 0 / 41 ( 0%) 0
Delusional disorder, persecutory type † A 0 / 39 ( 0%) 0 1 / 41 ( 2.44%) 1 0 / 41 ( 0%) 0
Mental status changes † A 1 / 39 ( 2.56%) 1 0 / 41 ( 0%) 0 0 / 41 ( 0%) 0
† Indicates events were collected by systematic assessment.
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Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
  Placebo Pimavanserin 10 mg Pimavanserin 20 mg
 Affected / At Risk (%)# EventsAffected / At Risk (%)# EventsAffected / At Risk (%)# Events
Total 12 / 39 ( 30.77%) 4 / 41 ( 9.76%) 8 / 41 ( 19.51%)
Injury, poisoning and procedural complications
Fall † A 3 / 39 ( 7.69%) 5 2 / 41 ( 4.88%) 3 3 / 41 ( 7.32%) 3
Nervous system disorders
Dizziness † A 2 / 39 ( 5.13%) 2 0 / 41 ( 0%) 0 1 / 41 ( 2.44%) 1
Somnolence † A 2 / 39 ( 5.13%) 2 1 / 41 ( 2.44%) 1 1 / 41 ( 2.44%) 1
Psychiatric disorders
Hallucination † A 2 / 39 ( 5.13%) 2 0 / 41 ( 0%) 0 2 / 41 ( 4.88%) 2
Insomnia † A 1 / 39 ( 2.56%) 1 0 / 41 ( 0%) 0 3 / 41 ( 7.32%) 3
Vascular disorders
Orthostatic hypotension † A 3 / 39 ( 7.69%) 3 2 / 41 ( 4.88%) 2 0 / 41 ( 0%) 0
† Indicates events were collected by systematic assessment.
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Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

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.

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.
Results Point of Contact:
Name/Official Title:
 Roger Mills, MD
Organization:
 ACADIA Pharmaceuticals Inc.
Phone:
 858-202-7563
Email:
 rmills@acadia-pharm.com
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
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