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

Phase 3 Completed 199 enrolled ACADIA Pharmaceuticals Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2010-07
Primary completion: 2012-11
Completion: 2012-11

Outcome

Met primary endpoint

paper pimavanserin was associated with a -5·79 decrease in SAPS-PD scores compared with -2·73 for placebo PMID 24183563 ↗

paper difference -3·06, 95% CI -4·91 to -1·20; p=0·001; Cohen's d 0·50 PMID 24183563 ↗

Publications

Cummings J, Isaacson S, Mills R, Williams H, Chi-Burris K, Corbett A, Dhall R, Ballard C. Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014 Feb 8;383(9916):533-40. doi: 10.1016/S0140-6736(13)62106-6. Epub 2013 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pimavanserin	Small molecule	40 mg	Oral