A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
NCT ID: NCT01174004
Last Updated: 2014-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
199 participants
INTERVENTIONAL
2010-07-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
pimavanserin tartrate
pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
2
placebo, tablet, once daily by mouth for 6 weeks
placebo
placebo, tablet, once daily by mouth for 6 weeks
Interventions
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pimavanserin tartrate
pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
placebo
placebo, tablet, once daily by mouth for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
40 Years
ALL
No
Sponsors
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ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Gilbert, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Carson, California, United States
Fountain Valley, California, United States
Fresno, California, United States
Fullerton, California, United States
Irvine, California, United States
La Habra, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Oxnard, California, United States
Pasadena, California, United States
Reseda, California, United States
Sunnyvale, California, United States
Ventura, California, United States
Danbury, Connecticut, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Panama City, Florida, United States
Port Charlotte, Florida, United States
St. Petersburg, Florida, United States
Augusta, Georgia, United States
Decatur, Georgia, United States
Elk Grove Village, Illinois, United States
Glenview, Illinois, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Novi, Michigan, United States
Roseville, Michigan, United States
Traverse City, Michigan, United States
Flowood, Mississippi, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Toms River, New Jersey, United States
Albany, New York, United States
Commack, New York, United States
Kingston, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Greensburg, Pennsylvania, United States
Providence, Rhode Island, United States
Brentwood, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Alexandria, Virginia, United States
Roanoke, Virginia, United States
Virginia Beach, Virginia, United States
Milwaukee, Wisconsin, United States
Ottawa, Ontario, Canada
Countries
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References
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Cummings J, Isaacson S, Mills R, Williams H, Chi-Burris K, Corbett A, Dhall R, Ballard C. Pimavanserin for patients with Parkinson's disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014 Feb 8;383(9916):533-40. doi: 10.1016/S0140-6736(13)62106-6. Epub 2013 Nov 1.
Other Identifiers
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ACP-103-020
Identifier Type: -
Identifier Source: org_study_id
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