A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
This study is currently recruiting participants.
Verified by ACADIA Pharmaceuticals Inc., February 2009
First Received: October 26, 2007 Last Updated: June 16, 2009 History of Changes
Sponsor:ACADIA Pharmaceuticals Inc.
Information provided by:ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:NCT00550238
Purpose
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
ConditionInterventionPhase
Parkinson's Disease Psychosis
Drug: pimavanserin tartrate (ACP-103)
Phase III
Study Type:Interventional
Study Design:Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
Resource links provided by NLM:
Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease Psychotic Disorders
Drug Information available for: Pimavanserin tartrate ACP 103
U.S. FDA Resources
Further study details as provided by ACADIA Pharmaceuticals Inc.:
Primary Outcome Measures:
Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Safety [ Time Frame: Duration of the treatment period ] [ Designated as safety issue: No ]
Estimated Enrollment:500
Study Start Date:July 2007
Estimated Primary Completion Date:December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
Drug: pimavanserin tartrate (ACP-103)
tablets once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Eligibility
Ages Eligible for Study: 40 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Subject has completed the treatment period of Study ACP-103-012
The subject is willing and able to provide consent
Caregiver is willing and able to accompany the subject to all visits
Exclusion Criteria:
Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
Subject is judged by the Investigator to be inappropriate for the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550238
Contacts
Contact: Kimberly Wilson
ACP-103clintrials@acadia-pharm.com
Show 43 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
More Information
No publications provided
Responsible Party:ACADIA Pharmaceuticals Inc. ( Kimberly Wilson )
Study ID Numbers:ACP-103-015
Study First Received:October 26, 2007
Last Updated:June 16, 2009
ClinicalTrials.gov Identifier:NCT00550238 History of Changes
Health Authority:United States: Food and Drug Administration
Keywords provided by ACADIA Pharmaceuticals Inc.:
Parkinson's Disease Psychosis
Additional relevant MeSH terms:
Mental Disorders
Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Psychotic Disorders
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Schizophrenia and Disorders with Psychotic Features
ClinicalTrials.gov processed this record on December 21, 2009
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