A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
NCT ID: NCT00550238
Last Updated: 2019-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
459 participants
INTERVENTIONAL
2007-07-31
2018-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Interventions
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Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Eligibility Criteria
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Inclusion Criteria
* The subject is willing and able to provide consent
* Caregiver is willing and able to accompany the subject to all visits
Exclusion Criteria
* Subject is judged by the Investigator to be inappropriate for the study
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
Tucson, Arizona, United States
Berkeley, California, United States
Carson, California, United States
Fountain Valley, California, United States
Fresno, California, United States
Irvine, California, United States
La Habra, California, United States
La Jolla, California, United States
Laguna Hills, 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
Englewood, Colorado, United States
Danbury, Connecticut, United States
Fairfield, Connecticut, United States
Farmington, Connecticut, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Deerfield Beach, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Panama City, Florida, United States
Pompano Beach, Florida, United States
Port Charlotte, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Decatur, Georgia, United States
Glenview, Illinois, United States
Springfield, Illinois, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Clinton Township, Michigan, United States
Detroit, Michigan, United States
East Lansing, Michigan, United States
Roseville, Michigan, United States
Traverse City, Michigan, United States
West Bloomfield, Michigan, United States
Columbia, Missouri, 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
Rochester, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
New Bern, 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
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Brentwood, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Alexandria, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Virginia Beach, Virginia, United States
Kirkland, Washington, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Innsbruck, , Austria
Vienna, , Austria
Roeselare, , Belgium
London, Ontario, Canada
Ottawa, Ontario, Canada
Clermont-Ferrand, , France
Marseille, , France
Nantes, , France
Pessac, , France
Strasbourg, , France
Bangalore, , India
Chennai, , India
Hyderabad, , India
Madurai, , India
Mangalore, , India
Mangalore, , India
Mumbai, , India
Mumbai, , India
Pune, , India
Pune, , India
Visakhapatnam, , India
Chieti, , Italy
Grosseto, , Italy
Rome, , Italy
Rome, , Italy
Bydgoszcz, , Poland
Katowice, , Poland
Lublin, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Kazan', , Russia
Kirov, , Russia
Moscow, , Russia
Pyatigorsk, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
Belgrade, , Serbia
Novi Sad, , Serbia
Stockholm, , Sweden
Kharkiv, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Luhansk, , Ukraine
Lviv, , Ukraine
Vinnitsia, , Ukraine
Barnsley, , United Kingdom
Blackburn, , United Kingdom
London, , United Kingdom
Newcastle, , United Kingdom
North Shields, , United Kingdom
Countries
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References
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Mathis MV, Muoio BM, Andreason P, Avila AM, Farchione T, Atrakchi A, Temple RJ. The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin. J Clin Psychiatry. 2017 Jun;78(6):e668-e673. doi: 10.4088/JCP.16r11119.
Ballard C, Isaacson S, Mills R, Williams H, Corbett A, Coate B, Pahwa R, Rascol O, Burn DJ. Impact of Current Antipsychotic Medications on Comparative Mortality and Adverse Events in People With Parkinson Disease Psychosis. J Am Med Dir Assoc. 2015 Oct 1;16(10):898.e1-7. doi: 10.1016/j.jamda.2015.06.021. Epub 2015 Aug 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ACP-103-015
Identifier Type: -
Identifier Source: org_study_id
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