At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 459 enrolled
Drug / intervention
Pimavanserin tartrate (ACP-103)drug
Likely dose
Not stated in 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, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
In Brief
A Phase 3 clinical trial evaluating Pimavanserin tartrate (ACP-103) for Parkinson's Disease Psychosis. Completed, enrolled 459 participants across 135 sites in 14 countries.
Detailed Summary
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease Psychosis
CountriesAustria, Belgium, Canada, France, India, Italy, Poland, Portugal, Russia, Serbia, Sweden, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedOct 2007
Primary CompletionMay 2018
TodayJul 2026
First PostedOct 29, 2007
Enrollment StartJul 1, 2007
Primary CompletionMay 30, 2018
TodayJul 2, 2026
Enrollment to primary: 10.9 yearsPosted 18.7 years ago
Interventions
Pimavanserin tartrate (ACP-103)drug
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects