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

Phase 3

Completed

• Conditions: Parkinson's Disease Psychosis
• Interventions: Drug: Pimavanserin tartrate (ACP-103)

• Registration Number: NCT00550238
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

Brief 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-10-26
• Study First Submitted QC: 2007-10-26
• Study First Posted: 2007-10-29
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Status Verified: 2019-05
• Results First Submitted: 2019-05-29
• Results First Submitted QC: 2019-05-29
• Last Update Submitted: 2019-05-29
• Results First Posted: 2019-06-24
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

• Subject has completed the treatment period of a previous blinded study of pimavanserin
• The subject is willing and able to provide consent
• Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria

• Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
• Subject is judged by the Investigator to be inappropriate for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pimavanserin tartrate (ACP-103)	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

Primary Outcome Measures

Name	Time	Method
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)	From first to last study drug dose plus 30 days	Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)