A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ACADIA Pharmaceuticals Inc.

ClinicalTrials.gov Identifier:

NCT01174004

First received: July 30, 2010

Last updated: December 3, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 30, 2010
Last Updated Date	December 3, 2012
Start Date ^ICMJE	July 2010
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 30, 2010)	Antipsychotic efficacy will be assessed using the Scale for the Assessment of Positive Symptoms (SAPS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01174004 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
Official Title ^ICMJE	A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease
Brief Summary	The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Parkinson's Disease Psychosis
Intervention ^ICMJE	Drug: pimavanserin tartrate pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks Other Name: ACP-103 Drug: placebo placebo, tablet, once daily by mouth for 6 weeks
Study Arm (s)	Experimental: 1 pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks Intervention: Drug: pimavanserin tartrate Placebo Comparator: 2 placebo, tablet, once daily by mouth for 6 weeks Intervention: Drug: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	199
Completion Date	November 2012
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 Subjects that are on anti-Parkinson's medication must be on a stable dose 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 Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment 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 (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic 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).
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT01174004
Other Study ID Numbers ^ICMJE	ACP-103-020
Has Data Monitoring Committee	No
Responsible Party	ACADIA Pharmaceuticals Inc.
Study Sponsor ^ICMJE	ACADIA Pharmaceuticals Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ACADIA Pharmaceuticals Inc.
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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