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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518309
First Posted: January 26, 2012
Last Update Posted: April 19, 2017
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.
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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) ]

Enrollment: 39
Study Start Date: November 2004
Study Completion Date: May 2013
Primary Completion Date: May 2013 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01518309


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

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01518309     History of Changes
Other Study ID Numbers: ACP-103-010
First Submitted: December 16, 2008
First Posted: January 26, 2012
Last Update Posted: April 19, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pimavanserin
Antiparkinson Agents
Anti-Dyskinesia Agents
Serotonin 5-HT2 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


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