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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00477672
First received: May 22, 2007
Last updated: February 6, 2014
Last verified: February 2014
  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)
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 ACP-103 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, 8, 15, 29 and 42) ] [ 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 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement.

    Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method.



Secondary Outcome Measures:
  • Motor Symptoms Change From Baseline (Negative = Improvement) [ Time Frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42) ] [ Designated as safety issue: Yes ]

    Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement.

    Analysis Method: ANCOVA, and missing data was imputed using LOCF. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each 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: 298
Study Start Date: June 2007
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
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, 6 weeks
Experimental: 3
Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Drug: Pimavanserin tartrate (ACP-103)
40 mg, tablet, once daily by mouth, 6 weeks
Drug: Placebo
tablet, once daily by mouth, 6 weeks
Placebo Comparator: 1
Placebo tablet, once daily by mouth, 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 PD 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 (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: NCT00477672

  Hide Study Locations
Locations
United States, Arizona
Gilbert, Arizona, United States, 85234
Phoenix, Arizona, United States, 85013
United States, California
Berkeley, California, United States, 94705
Carson, California, United States, 90746
Fountain Valley, California, United States, 92708
Irvine, California, United States, 92697
Sunnyvale, California, United States, 94805
United States, Connecticut
Danbury, Connecticut, United States, 06810
Fairfield, Connecticut, United States, 06824
United States, Florida
Boca Raton, Florida, United States, 33486
Gainsville, Florida, United States, 32610
Jacksonville, Florida, United States, 32209
Miami, Florida, United States, 33136
Pompano Beach, Florida, United States, 33060
Port Charlotte, Florida, United States, 33952
Sarasota, Florida, United States, 34239
St. Petersburg, Florida, United States, 33701
Tampa, Florida, United States, 33606
United States, Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Springfield, Illinois, United States, 62794
United States, Maine
Scarborough, Maine, United States, 04074
United States, Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
Southfield, Michigan, United States, 48034
Traverse City, Michigan, United States, 49684
United States, New Jersey
Toms River, New Jersey, United States, 08755
United States, New York
Kingston, New York, United States, 12401
Rochester, New York, United States, 14618
United States, North Carolina
Asheville, North Carolina, United States, 28806
Salisbury, North Carolina, United States, 28144
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Brentwood, Tennessee, United States, 37027
United States, Texas
San Antonio, Texas, United States, 78258
United States, Virginia
Richmond, Virginia, United States, 23229
United States, Washington
Kirkland, Washington, United States, 98034
Spokane, Washington, United States, 99204
Bulgaria
Pleven, Bulgaria, 5800
Rousse, Bulgaria, 7003
Sofia, Bulgaria, 1113
Varna, Bulgaria, 9010
France
Clermont ferrand, France, 63003
Marseille, France, 13385
Nantes, France, 44093
Pessac, France, 33604
Strasbourg, France, 67091
Toulouse, France, 35059
India
Bangalore, India, 560034
Hyderabad, India, 500003
Karnataka, India, 575001
Mangalore, India, 575002
Mumbai, India, 400036
Mumbai, India, 400016
New Dalhi, India, 110060
Pune, India, 411030
Pune, India, 411004
Tamil Nadu, India, 600006
Tamil Nadu, India, 625020
Visakhapatnam, India, 530001
Russian Federation
Kazan, Russian Federation, 420061
Kirov, Russian Federation, 610014
Moscow, Russian Federation, 125284
Samara, Russian Federation, 443095
Smolensk, Russian Federation, 214018
St. Petersburg, Russian Federation, 194044
Ukraine
Kharkiv, Ukraine, 61068
Kiev, Ukraine, 04114
Kiev, Ukraine, 04080
Lugansk, Ukraine, 91045
Lviv, Ukraine, 79010
Vinnytsia, Ukraine, 21005
United Kingdom
Barnsley, United Kingdom, S75 2EP
Blackburn, United Kingdom, BB3 2HH
Brighton, United Kingdom, BN2 5BE
Dorset, United Kingdom, BH23 2JX
London, United Kingdom, NW3 2PF
Newcastle upon Tyne, United Kingdom, NE4 6BE
North Shields, United Kingdom, NE29 8NH
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00477672     History of Changes
Other Study ID Numbers: ACP-103-012
Study First Received: May 22, 2007
Results First Received: February 6, 2014
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ACADIA Pharmaceuticals Inc.:
Parkinson's disease, psychotic disorders

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 17, 2014