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 January 2012 by ACADIA Pharmaceuticals Inc.

First Received on October 26, 2007. Last Updated on January 10, 2012 History of Changes

Sponsor:	ACADIA Pharmaceuticals Inc.
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 Perry syndrome

MedlinePlus related topics: Mental Disorders 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 2012 (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 a previous blinded study of pimavanserin
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: Mary Aloisio

858-320-8620

maloisio@acadia-pharm.com

Show 127 Study Locations

Sponsors and Collaborators

ACADIA Pharmaceuticals Inc.

More Information

No publications provided

Responsible Party:	ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00550238 History of Changes
Other Study ID Numbers:	ACP-103-015
Study First Received:	October 26, 2007
Last Updated:	January 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by ACADIA Pharmaceuticals Inc.:

Parkinson's Disease Psychosis

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 February 09, 2012