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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
  Purpose

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).


Condition Intervention Phase
Parkinson's Disease Psychosis
 Drug: pimavanserin tartrate
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 199
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
 Drug: pimavanserin tartrate
pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
Other Name: ACP-103
Placebo Comparator: 2
placebo, tablet, once daily by mouth for 6 weeks
 Drug: placebo
placebo, tablet, once daily by mouth for 6 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
  • 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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174004

  Show 63 Study Locations
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01174004     History of Changes
Other Study ID Numbers: ACP-103-020
Study First Received: July 30, 2010
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

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 May 21, 2013