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OpenTrials
Completed

NCT Number: NCT01518309

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

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).

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Key information

Conditions

Parkinson's Disease Psychosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Danbury, Connecticut, 06810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pimavanserin tartrate (ACP-103)

Drug

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

Primary outcomes

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

    Time frame: From first to last study drug dose plus 30 days

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

Sponsors and collaborators

Lead sponsor

ACADIA Pharmaceuticals Inc.

Industry

Registry information

Important dates

Study start
2004
Primary completion
2013
Study completion
2013
First posted
Jan 26, 2012
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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