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

Primary Purpose

Parkinson's Disease Psychosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

pimavanserin tartrate (ACP-103)

About this trial

This is an interventional treatment trial for Parkinson's Disease Psychosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pimavanserin tartrate (ACP-103)

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01518309

First Posted

December 16, 2008

Last Updated

October 27, 2020

Sponsor

ACADIA Pharmaceuticals Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01518309

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

November 17, 2004 (Actual)

Primary Completion Date

May 2, 2013 (Actual)

Study Completion Date

May 2, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ACADIA Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease Psychosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pimavanserin tartrate (ACP-103)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

pimavanserin tartrate (ACP-103)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

From first to last study drug dose plus 30 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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