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NCT03325556 · ClinicalTrials.gov registry record · Phase 3
Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
A Phase 3 study, sponsored by ACADIA Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 392
- Enrollment target
NCT03325556: Completed Phase 3 study, sponsored by ACADIA Pharmaceuticals.
NCT03325556 is a Phase 3 study that has completed, run by ACADIA Pharmaceuticals. The registered enrollment target is 392 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03325556, a Phase 3 study, has completed, sponsored by ACADIA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 392 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.
Primary Outcome
The time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR). Relapse was defined as (1) ≥30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score ≥6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalization for worsening dementia
Interventions
- DRUG Placebo
- DRUG Pimavanserin 34 mg
- DRUG Pimavanserin 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2017-09-27 |
| Est. Completion | 2019-10-30 |
| Phase | Phase 3 |
What the finished NCT03325556 record still lists
NCT03325556 is an interventional study that assigns participants to a tested intervention. The registered 392 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 (49% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03325556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03325556 about?
NCT03325556 is a clinical study titled "Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis". The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.
What is the current status of trial NCT03325556?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 392 participants. The study started on 2017-09-27. Estimated completion is 2019-10-30.
What interventions are being tested in trial NCT03325556?
The interventions under investigation include: Placebo (DRUG), Pimavanserin 34 mg (DRUG), Pimavanserin 20 mg (DRUG).
Who is sponsoring clinical trial NCT03325556?
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 NCT03325556's enrollment target sits among peer trials
392 967th of 2000 higher than 1,033 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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