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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01518309
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : April 19, 2017
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

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).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2004
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety [ Time Frame: For as long as pimavanserin is considered to be tolerated and beneficial to enrolled patients (up to 8 years) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01518309

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

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Responsible Party: ACADIA Pharmaceuticals Inc. Identifier: NCT01518309     History of Changes
Other Study ID Numbers: ACP-103-010
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action