At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 298 enrolled
Drug / intervention
Pimavanserin tartrate (ACP-103) +2 moredrug
Likely dose
Pimavanserin tartrate (ACP-103) 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
In Brief
A Phase 3 clinical trial evaluating Pimavanserin tartrate (ACP-103) and Placebo for Parkinson's Disease Psychosis. Completed, enrolled 298 participants across 78 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease Psychosis
CountriesBulgaria, France, India, Russia, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJun 2007
Primary CompletionJun 2009
Study CompletionJul 2009
TodayJul 2026
First PostedMay 24, 2007
Enrollment StartJun 1, 2007
Primary CompletionJun 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.1 years ago
Interventions
Pimavanserin tartrate (ACP-103)drug
10 mg, tablet, once daily by mouth, 6 weeks
Pimavanserin tartrate (ACP-103)drug
40 mg, tablet, once daily by mouth, 6 weeks
Placebodrug
tablet, once daily by mouth, 6 weeks