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NCT01174004 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of Pimavanserin 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
- 199
- Enrollment target
- 20
- Study locations
NCT01174004: Completed Phase 3 study of Parkinson's Disease Psychosis, sponsored by ACADIA Pharmaceuticals.
NCT01174004 is a Phase 3 study of Parkinson's Disease Psychosis that has completed, run by ACADIA Pharmaceuticals. The registered enrollment target is 199 participants, below the 250-participant average among 3 other Parkinson's Disease Psychosis trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01174004, a Phase 3 study of Parkinson's Disease Psychosis, has completed, sponsored by ACADIA Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 199 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).
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 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement. Analysis Method: Mixed Model Repeated Measures (MMRM)
Conditions Studied
Interventions
- DRUG placebo
- DRUG pimavanserin tartrate
Study Locations (20)
California
- - Carson
- - Fountain Valley
- - Fresno
- - Fullerton
- - Irvine
- - La Habra
- - La Jolla
- - Loma Linda
- - Oxnard
- - Pasadena
- - Reseda
- - Sunnyvale
- - Ventura
Arizona
- - Gilbert
- - Phoenix
- - Phoenix
- - Tucson
Florida
- - Boca Raton
- - Bradenton
Connecticut
- - Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01174004 record still lists
NCT01174004 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 250-participant average among 3 other Parkinson's Disease Psychosis trials with a reported enrollment target (20% lower).
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.
NCT01174004 names 20 study sites across 4 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT01174004 about?
NCT01174004 is a clinical study titled "A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis". The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).
What is the current status of trial NCT01174004?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2010-07. Estimated completion is 2012-11.
What conditions does trial NCT01174004 study?
This clinical trial studies the following conditions: Parkinson's Disease Psychosis.
What interventions are being tested in trial NCT01174004?
The interventions under investigation include: placebo (DRUG), pimavanserin tartrate (DRUG).
Who is sponsoring clinical trial NCT01174004?
This trial is sponsored by ACADIA Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01174004 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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