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., November 2008

Sponsored by:	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.

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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease Psychotic Disorders

Drug Information available for: ACP 103

U.S. FDA Resources

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

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:

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 38 Study Locations

Sponsors and Collaborators

ACADIA Pharmaceuticals Inc.

More Information

Responsible Party:	ACADIA Pharmaceuticals Inc. ( Kimberly Wilson )
Study ID Numbers:	ACP-103-015
Study First Received:	October 26, 2007
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00550238
Health Authority:	United States: Food and Drug Administration

Keywords provided by ACADIA Pharmaceuticals Inc.:

Parkinson's Disease Psychosis

Study placed in the following topic categories:

Schizophrenia
Ganglion Cysts
Mental Disorders
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Psychotic Disorders
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009