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

NCT ID: NCT01518309

Last Updated: 2020-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-17

Study Completion Date

2013-05-02

Brief Summary

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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

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Conditions

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Parkinson's Disease Psychosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pimavanserin tartrate (ACP-103)

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

Group Type EXPERIMENTAL

pimavanserin tartrate (ACP-103)

Intervention Type DRUG

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

Interventions

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pimavanserin tartrate (ACP-103)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ACADIA Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Danbury, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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ACP-103-010

Identifier Type: -

Identifier Source: org_study_id