A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
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
1 other identifier
interventional
298
7 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2007
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
March 26, 2014
CompletedMay 17, 2017
April 1, 2017
2 years
May 22, 2007
February 6, 2014
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Secondary Outcomes (1)
Motor Symptoms Change From Baseline (Negative = Improvement)
Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Study Arms (3)
2
EXPERIMENTALPimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks
3
EXPERIMENTALPimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
1
PLACEBO COMPARATORPlacebo tablet, once daily by mouth, 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Unknown Facility
Gilbert, Arizona, 85234, United States
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Phoenix, Arizona, 85013, United States
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Berkeley, California, 94705, United States
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Carson, California, 90746, United States
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Fountain Valley, California, 92708, United States
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Irvine, California, 92697, United States
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Sunnyvale, California, 94805, United States
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Danbury, Connecticut, 06810, United States
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Fairfield, Connecticut, 06824, United States
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Boca Raton, Florida, 33486, United States
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Gainesville, Florida, 32610, United States
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Jacksonville, Florida, 32209, United States
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Miami, Florida, 33136, United States
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Pompano Beach, Florida, 33060, United States
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Port Charlotte, Florida, 33952, United States
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Sarasota, Florida, 34239, United States
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St. Petersburg, Florida, 33701, United States
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Tampa, Florida, 33606, United States
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Augusta, Georgia, 30912, United States
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Springfield, Illinois, 62794, United States
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Scarborough, Maine, 04074, United States
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Worcester, Massachusetts, 01655, United States
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Southfield, Michigan, 48034, United States
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Traverse City, Michigan, 49684, United States
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Toms River, New Jersey, 08755, United States
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Kingston, New York, 12401, United States
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Rochester, New York, 14618, United States
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Asheville, North Carolina, 28806, United States
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Salisbury, North Carolina, 28144, United States
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Columbus, Ohio, 43210, United States
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Warwick, Rhode Island, 02886, United States
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Brentwood, Tennessee, 37027, United States
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San Antonio, Texas, 78258, United States
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Richmond, Virginia, 23229, United States
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Kirkland, Washington, 98034, United States
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Spokane, Washington, 99204, United States
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Pleven, 5800, Bulgaria
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Rousse, 7003, Bulgaria
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Sofia, 1113, Bulgaria
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Varna, 9010, Bulgaria
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Clermont-Ferrand, 63003, France
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Marseille, 13385, France
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Nantes, 44093, France
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Pessac, 33604, France
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Strasbourg, 67091, France
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Toulouse, 35059, France
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Bangalore, 560034, India
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Hyderabad, 500003, India
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Karnataka, 575001, India
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Mangalore, 575002, India
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Mumbai, 400016, India
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Mumbai, 400036, India
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New Dalhi, 110060, India
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Pune, 411004, India
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Pune, 411030, India
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Tamil Nadu, 600006, India
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Tamil Nadu, 625020, India
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Visakhapatnam, 530001, India
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Kazan', 420061, Russia
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Kirov, 610014, Russia
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Moscow, 125284, Russia
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Saint Petersburg, 194044, Russia
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Samara, 443095, Russia
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Smolensk, 214018, Russia
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Kharkiv, 61068, Ukraine
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Kiev, 04080, Ukraine
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Kiev, 04114, Ukraine
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Luhansk, 91045, Ukraine
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Lviv, 79010, Ukraine
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Vinnytsia, 21005, Ukraine
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Barnsley, S75 2EP, United Kingdom
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Blackburn, BB3 2HH, United Kingdom
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Brighton, BN2 5BE, United Kingdom
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Dorset, BH23 2JX, United Kingdom
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London, NW3 2PF, United Kingdom
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Newcastle upon Tyne, NE4 6BE, United Kingdom
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North Shields, NE29 8NH, United Kingdom
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Salford, M6 8HD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roger Mills, MD
- Organization
- ACADIA Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2007
First Posted
May 24, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2009
Study Completion
July 1, 2009
Last Updated
May 17, 2017
Results First Posted
March 26, 2014
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share