An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients

Phase 2

Completed

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

• Registration Number: NCT01518309
• Lead Sponsor: ACADIA Pharmaceuticals Inc.

Brief Summary

This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-17
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Primary Completion: 2013-05-02
• Study Completion: 2013-05-02
• Results First Submitted: 2020-09-11
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Results First Posted: 2020-11-23
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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 at 20, 40, or 60 mg doses

Primary Outcome Measures

Name	Time	Method
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