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A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
This study is currently recruiting participants.
Verified by ACADIA Pharmaceuticals Inc., July 2009
First Received: April 10, 2008   Last Updated: July 16, 2009   History of Changes
Sponsor: ACADIA Pharmaceuticals Inc.
Information provided by: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00658567
  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

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

Resource links provided by NLM:


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 (i.e., 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

  Hide Study Locations
Locations
United States, California
Recruiting
Reseda, California, United States
Recruiting
Ventura, California, United States, 93003
Recruiting
Laguna HIlls, California, United States, 92653
Recruiting
La Habra, California, United States, 90631
United States, Colorado
Recruiting
Englewood, Colorado, United States, 80113
United States, Connecticut
Recruiting
Farmington, Connecticut, United States, 06030
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
Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Recruiting
Clinton Twp, Michigan, United States, 48035
Recruiting
East lansing, Michigan, United States, 48824
Recruiting
Detroit, Michigan, United States, 48201
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
Recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Recruiting
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19131
Recruiting
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
Recruiting
Houston, Texas, United States, 77030
United States, Vermont
Recruiting
Burlington, Vermont, United States, 05401
Austria
Recruiting
Innsbruck, Austria, 6020
Belgium
Recruiting
Roeselare, Belgium, 8800
Recruiting
Ottignies, Belgium, 1340
Recruiting
Brussels, Belgium, 1090
Italy
Recruiting
Grossetto, Italy, 58100
Recruiting
Chieti Scalo, Italy, 66013
Recruiting
Roma, Italy, 00163
Recruiting
Roma, Italy, 00185
Poland
Recruiting
Lublin, Poland, 20-090
Recruiting
Lodz, Poland, 90-130
Recruiting
Bydgoszcz, Poland, 85-096
Recruiting
Katowice, Poland, 40-752
Portugal
Recruiting
Coimbra, Portugal, 3000-548
Recruiting
Lisboa, Portugal, 1649-028
Recruiting
Porto, Portugal, 4099-001
Serbia
Recruiting
Belgrade, Serbia, 11000
Spain
Recruiting
Barcelona, Spain, 08003
Recruiting
Barcelona, Spain, 08195
Recruiting
Barcelona, Spain, 08036
Recruiting
Santiago De Compostela, Spain, 15706
Recruiting
San Sebastian, Spain, 20009
Sweden
Recruiting
Stockholm, Sweden, SE-112 45
Recruiting
Linkoping, Sweden, SE-581 85
Recruiting
Jonkoping, Sweden, SE-551 85
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: ACADIA Pharmaceuticals Inc. ( Kimberly Wilson )
Study ID Numbers: ACP-103-014
Study First Received: April 10, 2008
Last Updated: July 16, 2009
ClinicalTrials.gov Identifier: NCT00658567     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mental Disorders
Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Psychotic Disorders
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009