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

NCT01518309 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ACP-103-010
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson's Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)

  Number (%) of patients with drug-related treatment-emergent AEs

  From first to last study drug dose plus 30 days

Study Arms (1)

pimavanserin tartrate (ACP-103)

EXPERIMENTAL

Tablets taken once daily by mouth at 20, 40, or 60 mg doses

Drug: pimavanserin tartrate (ACP-103)

Interventions

pimavanserin tartrate (ACP-103) DRUG

Tablets taken once daily by mouth at 20, 40, or 60 mg doses

pimavanserin tartrate (ACP-103)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin
• Patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin
• Patient is willing and able to provide consent

You may not qualify if:

• Female patient of childbearing potential
• Patient has a clinically significant concurrent medical illness
• Patient is judged by the treating physician to be inappropriate for the study.

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (1)

Unknown Facility

Danbury, Connecticut, 06810, United States

Location

MeSH Terms

Interventions

pimavanserin

Results Point of Contact

• Title: Sr. Dir. Medical Information and Medical Communications
• Organization: ACADIA Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

858-261-2897

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: January 26, 2012
• Study Start: November 17, 2004
• Primary Completion: May 2, 2013
• Study Completion: May 2, 2013
• Last Updated: November 23, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-10

Locations

US (1)