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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01518309
First received: December 16, 2008
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Parkinson's Disease Psychosis
 Drug: pimavanserin tartrate (ACP-103)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: For as long as pimavanserin is considered to be tolerated and beneficial to enrolled patients (up to 8 years) ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: November 2004
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth at 20, 40, or 60 mg doses
 Drug: pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth at 20, 40, or 60 mg doses

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518309

Locations
United States, Connecticut
Danbury, Connecticut, United States, 06810
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01518309     History of Changes
Other Study ID Numbers: ACP-103-010
Study First Received: December 16, 2008
Last Updated: January 25, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Mental Disorders
Psychotic Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 16, 2013