Back to resultsA Study of the 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)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease Psychosis focused on measuring Parkinson's disease, psychotic disorders
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 PD 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
Experimental
Placebo Comparator
Arm Label
2
3
1
Arm Description
Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks
Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Placebo 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 0 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) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement.
Analysis Method: ANCOVA, and missing data was imputed using LOCF. 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
NCT00477672
First Posted
May 22, 2007
Last Updated
April 18, 2017
Sponsor
ACADIA Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00477672
Brief Title
A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Official Title
A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 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
Keywords
Parkinson's disease, psychotic disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo 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, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Pimavanserin tartrate (ACP-103)
Intervention Description
40 mg, tablet, once daily by mouth, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, once daily by mouth, 6 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 0 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) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement.
Analysis Method: ANCOVA, and missing data was imputed using LOCF. 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 PD 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
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
City
Carson
State/Province
California
ZIP/Postal Code
90746
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94805
Country
United States
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Rousse
ZIP/Postal Code
7003
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Clermont ferrand
ZIP/Postal Code
63003
Country
France
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Nantes
ZIP/Postal Code
44093
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Toulouse
ZIP/Postal Code
35059
Country
France
City
Bangalore
ZIP/Postal Code
560034
Country
India
City
Hyderabad
ZIP/Postal Code
500003
Country
India
City
Karnataka
ZIP/Postal Code
575001
Country
India
City
Mangalore
ZIP/Postal Code
575002
Country
India
City
Mumbai
ZIP/Postal Code
400016
Country
India
City
Mumbai
ZIP/Postal Code
400036
Country
India
City
New Dalhi
ZIP/Postal Code
110060
Country
India
City
Pune
ZIP/Postal Code
411004
Country
India
City
Pune
ZIP/Postal Code
411030
Country
India
City
Tamil Nadu
ZIP/Postal Code
600006
Country
India
City
Tamil Nadu
ZIP/Postal Code
625020
Country
India
City
Visakhapatnam
ZIP/Postal Code
530001
Country
India
City
Kazan
ZIP/Postal Code
420061
Country
Russian Federation
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
City
Kiev
ZIP/Postal Code
04080
Country
Ukraine
City
Kiev
ZIP/Postal Code
04114
Country
Ukraine
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
City
Blackburn
ZIP/Postal Code
BB3 2HH
Country
United Kingdom
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
City
Dorset
ZIP/Postal Code
BH23 2JX
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
City
North Shields
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
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