NCT00550238

A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 459 (actual)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

Detailed description

This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.

Conditions

• Parkinson's Disease Psychosis

Interventions

Type	Name	Description
DRUG	Pimavanserin tartrate (ACP-103)	Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

Timeline

• Start date: 2007-07-01
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2007-10-29
• Last updated: 2019-06-24
• Results posted: 2019-06-24

Locations

135 sites across 14 countries: United States, Austria, Belgium, Canada, France, India, Italy, Poland, Portugal, Russia, Serbia, Sweden, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study