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

Acadia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease Psychosis

Treatments: Drug: pimavanserin tartrate (ACP-103)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518309

ACP-103-010

Details and patient eligibility

About

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).

Enrollment: 39 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

pimavanserin tartrate (ACP-103)

Experimental group

Description:

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

Treatment:

Drug: pimavanserin tartrate (ACP-103)