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: February 6, 2014
Last verified: February 2014
  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:


Further study details as provided by ACADIA Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Antipsychotic Efficacy [ Time Frame: Each study visit (i.e. Days 1, 15, 29 and 43) ] [ Designated as safety issue: No ]

    Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement.

    Analysis Method: Mixed Model Repeated Measures (MMRM)



Secondary Outcome Measures:
  • Motor Symptoms Change From Baseline (Negative = Improvement) [ Time Frame: Study Days 1 and 43 ] [ Designated as safety issue: Yes ]

    Motor symptoms were measured using the change from baseline to Day 43 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The possible total score is 0 to 160 and a negative change in score indicates improvement.

    Analysis Method: Analysis of Covariance (ANCOVA). The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between the pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5.



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

  Hide Study Locations
Locations
United States, Arizona
Gilbert, Arizona, United States, 85234
Phoenix, Arizona, United States, 85004
Phoenix, Arizona, United States, 85013
Tucson, Arizona, United States, 85724
United States, California
Carson, California, United States, 90746
Fountain Valley, California, United States, 92708
Fresno, California, United States, 93720
Fullerton, California, United States, 92835
Irvine, California, United States, 92697
La Habra, California, United States, 90631
La Jolla, California, United States, 92037
Loma Linda, California, United States, 92354
Oxnard, California, United States, 93030
Pasadena, California, United States, 91105
Reseda, California, United States, 91335
Sunnyvale, California, United States, 94085
Ventura, California, United States, 93003
United States, Connecticut
Danbury, Connecticut, United States, 06810
United States, Florida
Boca Raton, Florida, United States, 33486
Bradenton, Florida, United States, 34205
Naples, Florida, United States, 34102
Orlando, Florida, United States, 32806
Ormond Beach, Florida, United States, 32174
Panama City, Florida, United States, 32405
Port Charlotte, Florida, United States, 33980
St. Petersburg, Florida, United States, 33713
United States, Georgia
Augusta, Georgia, United States, 30912
Decatur, Georgia, United States, 30033
United States, Illinois
Elk Grove Village, Illinois, United States, 60007
Glenview, Illinois, United States, 60026
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Maine
Scarborough, Maine, United States, 04074
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Novi, Michigan, United States, 48377
Roseville, Michigan, United States, 48066
Traverse City, Michigan, United States, 49684
United States, Mississippi
Flowood, Mississippi, United States, 39232
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Montana
Missoula, Montana, United States, 59802
United States, New Jersey
Toms River, New Jersey, United States, 08755
United States, New York
Albany, New York, United States, 12208
Commack, New York, United States, 11725
Kingston, New York, United States, 12401
New York, New York, United States, 10016
United States, North Carolina
Durham, North Carolina, United States, 27705
Raleigh, North Carolina, United States, 27607
Salisbury, North Carolina, United States, 28144
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43210
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Greensburg, Pennsylvania, United States, 15601
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, Tennessee
Brentwood, Tennessee, United States, 37027
United States, Texas
Houston, Texas, United States, 77030
United States, Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
Alexandria, Virginia, United States, 22311
Roanoke, Virginia, United States, 24018
Virginia Beach, Virginia, United States, 23456
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53233
Canada, Ontario
Ottawa, Ontario, Canada, K1G 4G3
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

No publications provided by ACADIA Pharmaceuticals Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: February 6, 2014
Last Updated: February 6, 2014
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 April 23, 2014