A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis - Full Text View

Purpose

This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients 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

ChemIDplus related topics:

ACP 103

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:

Antipsychotic efficacy will be assessed using the scale for the assessment of Positive Symptoms (SAPS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	March 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks	Drug: Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, for six weeks
3: Placebo Comparator Placebo tablet, once daily by mouth, 6 weeks	Drug: Pimavanserin tartrate (ACP-103) Placebo, tablet, once daily by mouth, for six weeks
1: Experimental pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks	Drug: Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, for six weeks

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
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 a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
Subject has received previous ablative stereotaxic surgery (is., pallidotomy and thalamotomy) to treat Parkinson's disease
Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, mematologic or other medical disorder
Subject has had a myocardial infarction in last six months
Subject has any surgery planned during the screening, treatment or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658567

Contacts


Contact: Kimberly Wilson		ACP-103clintrials@acadia-pharm.com

Locations


United States, California
		Recruiting
	Reseda, California, United States
		Recruiting
	Ventura, California, United States, 93003
		Recruiting
	Laguna HIlls, California, United States, 92653

United States, Colorado
		Recruiting
	Englewood, Colorado, United States, 80113

United States, Florida
		Recruiting
	Sarasota, Florida, United States, 34233
		Recruiting
	Deerfield Beach, Florida, United States, 33064
		Recruiting
	Panama City, Florida, United States, 32405

United States, Massachusetts
		Recruiting
	Boston, Massachusetts, United States, 02215

United States, Michigan
		Recruiting
	Clinton Twp, Michigan, United States, 48035
		Recruiting
	East lansing, Michigan, United States, 48824

United States, Missouri
		Recruiting
	Columbia, Missouri, United States, 65201

United States, Nebraska
		Recruiting
	Omaha, Nebraska, United States, 68131

United States, New York
		Recruiting
	Albany, New York, United States, 12208
		Recruiting
	Commack, New York, United States, 11725

United States, North Carolina
		Recruiting
	New Bern, North Carolina, United States
		Recruiting
	Charlotte, North Carolina, United States, 28204

Austria
		Recruiting
	Innsbruck, Austria, 6020

Poland
		Recruiting
	Lublin, Poland, 20-090
		Recruiting
	Lodz, Poland, 90-130
		Recruiting
	Bydgoszcz, Poland, 85-796

Spain
		Recruiting
	Barcelona, Spain, 08003

Sponsors and Collaborators

ACADIA Pharmaceuticals Inc.

More Information

Responsible Party:	ACADIA Pharmaceuticals Inc. ( Kimberly Wilson )
Study ID Numbers:	ACP-103-014
First Received:	April 10, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00658567
Health Authority:	United States: Food and Drug Administration