A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Parkinson's Disease Psychosis

In brief

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).

Key facts

Study ID

NCT01174004

Run by

ACADIA Pharmaceuticals Inc.

People needed

199

Starts

2010-07-01

Expected to finish

2012-11-01

Last updated by the study team

2014-03-26

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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 Parkinson's disease diagnosis was established
• Subjects that are on anti-Parkinson's medication must be on a stable dose 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
• Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment

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).

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Carson, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Fresno, California, United States
• Study site — Fullerton, California, United States
• Study site — Irvine, California, United States
• Study site — La Habra, California, United States
• Study site — La Jolla, California, United States
• Study site — Loma Linda, California, United States
• Study site — Oxnard, California, United States
• Study site — Pasadena, California, United States
• Study site — Reseda, California, United States
• Study site — Sunnyvale, California, United States
• Study site — Ventura, California, United States
• Study site — Danbury, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Panama City, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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