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

Parkinson's Disease Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518309
• Other study ID #: ACP-103-010
• Status: Completed
• Phase: Phase 2
• Start date: November 17, 2004
• Est. completion date: May 2, 2013

Study information

• Verified date: October 2020
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2, 2013
• Est. primary completion date: May 2, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria-

• 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

Exclusion Criteria-

• 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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease Psychosis

Intervention

Drug:
• pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth at 20, 40, or 60 mg doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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