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NCT00658567 · ClinicalTrials.gov registry record · Phase 3
A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
A Phase 3 study, sponsored by ACADIA Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
NCT00658567: Completed Phase 3 study, sponsored by ACADIA Pharmaceuticals.
NCT00658567 is a Phase 3 study that has completed, run by ACADIA Pharmaceuticals. The registered enrollment target is 123 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658567, a Phase 3 study, has completed, sponsored by ACADIA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
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 1 to 100 and a negative change in score indicates improvement. Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Obse
Interventions
- DRUG Pimavanserin tartrate (ACP-103)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00658567 record still lists
NCT00658567 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Pimavanserin tartrate (ACP-103) is the first listed.
NCT00658567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00658567 about?
NCT00658567 is a clinical study titled "A Study of 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 NCT00658567?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2008-03. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00658567?
The interventions under investigation include: Pimavanserin tartrate (ACP-103) (DRUG).
Who is sponsoring clinical trial NCT00658567?
This trial is sponsored by ACADIA Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00658567's enrollment target sits among peer trials
123 1615th of 2000 higher than 384 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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