Back to resultsA Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Primary Purpose
Parkinson's Disease Psychosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimavanserin tartrate (ACP-103)
Pimavanserin tartrate (ACP-103)
Pimavanserin tartrate (ACP-103)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease Psychosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
- Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, 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
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
2
Placebo
1
Arm Description
pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
Placebo tablet, once daily by mouth, 6 weeks
pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
Outcomes
Primary Outcome Measures
Antipsychotic Efficacy
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.
Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method.
Secondary Outcome Measures
Motor Symptoms Change From Baseline (Negative = Improvement)
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.
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.
Full Information
NCT ID
NCT00658567
First Posted
April 10, 2008
Last Updated
April 18, 2017
Sponsor
ACADIA Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00658567
Brief Title
A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet, once daily by mouth, 6 weeks
Arm Title
1
Arm Type
Experimental
Arm Description
pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Pimavanserin tartrate (ACP-103)
Intervention Description
10 mg, tablet, once daily by mouth, for six weeks
Intervention Type
Drug
Intervention Name(s)
Pimavanserin tartrate (ACP-103)
Intervention Description
20 mg, tablet, once daily by mouth, for six weeks
Intervention Type
Drug
Intervention Name(s)
Pimavanserin tartrate (ACP-103)
Intervention Description
Placebo, tablet, once daily by mouth, for six weeks
Primary Outcome Measure Information:
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.
Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method.
Time Frame
Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Secondary Outcome Measure Information:
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.
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.
Time Frame
Each study visit (i.e. Days 1, 8, 15, 29 and 42)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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 (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, 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
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).
Facility Information:
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Reseda
State/Province
California
Country
United States
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
City
Clinton
State/Province
Michigan
ZIP/Postal Code
48035
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
New Bern
State/Province
North Carolina
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
City
Chieti Scalo
ZIP/Postal Code
66013
Country
Italy
City
Grossetto
ZIP/Postal Code
58100
Country
Italy
City
Roma
ZIP/Postal Code
00163
Country
Italy
City
Roma
ZIP/Postal Code
00185
Country
Italy
City
Bydgoszcz
ZIP/Postal Code
85-096
Country
Poland
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
City
Lodz
ZIP/Postal Code
90-130
Country
Poland
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-028
Country
Portugal
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
City
San Sebastian
ZIP/Postal Code
20009
Country
Spain
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
City
Jonkoping
ZIP/Postal Code
SE-551 85
Country
Sweden
City
Linkoping
ZIP/Postal Code
SE-581 85
Country
Sweden
City
Stockholm
ZIP/Postal Code
SE-112 45
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
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