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NCT00477672 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
A Phase 3 study of Parkinson's Disease Psychosis, sponsored by ACADIA Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 298
- Enrollment target
- 20
- Study locations
NCT00477672: Completed Phase 3 study of Parkinson's Disease Psychosis, sponsored by ACADIA Pharmaceuticals.
NCT00477672 is a Phase 3 study of Parkinson's Disease Psychosis that has completed, run by ACADIA Pharmaceuticals. The registered enrollment target is 298 participants, above the 217-participant average among 3 other Parkinson's Disease Psychosis trials with a reported enrollment target (37% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00477672, a Phase 3 study of Parkinson's Disease Psychosis, has completed, sponsored by ACADIA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 298 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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 Obse
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pimavanserin tartrate (ACP-103)
Study Locations (20)
Florida
- - Boca Raton
- - Gainesville
- - Jacksonville
- - Miami
- - Pompano Beach
- - Port Charlotte
- - Sarasota
- - St. Petersburg
- - Tampa
California
- - Berkeley
- - Carson
- - Fountain Valley
- - Irvine
- - Sunnyvale
Arizona
- - Gilbert
- - Phoenix
Connecticut
- - Danbury
- - Fairfield
Georgia
- - Augusta
Illinois
- - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00477672 record still lists
NCT00477672 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 3 other Parkinson's Disease Psychosis trials with a reported enrollment target (37% higher).
The record links to 1 condition, with Parkinson's Disease Psychosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00477672 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT00477672 about?
NCT00477672 is a clinical study titled "A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis". 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.
What is the current status of trial NCT00477672?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 298 participants. The study started on 2007-06. Estimated completion is 2009-07.
What conditions does trial NCT00477672 study?
This clinical trial studies the following conditions: Parkinson's Disease Psychosis.
What interventions are being tested in trial NCT00477672?
The interventions under investigation include: Placebo (DRUG), Pimavanserin tartrate (ACP-103) (DRUG).
Who is sponsoring clinical trial NCT00477672?
This trial is sponsored by ACADIA Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00477672 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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