A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
NCT ID: NCT00477672
Last Updated: 2017-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
298 participants
INTERVENTIONAL
2007-06-30
2009-07-31
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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2
Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks
Pimavanserin tartrate (ACP-103)
10 mg, tablet, once daily by mouth, 6 weeks
3
Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
Pimavanserin tartrate (ACP-103)
40 mg, tablet, once daily by mouth, 6 weeks
1
Placebo tablet, once daily by mouth, 6 weeks
Placebo
tablet, once daily by mouth, 6 weeks
Interventions
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Pimavanserin tartrate (ACP-103)
10 mg, tablet, once daily by mouth, 6 weeks
Pimavanserin tartrate (ACP-103)
40 mg, tablet, once daily by mouth, 6 weeks
Placebo
tablet, once daily by mouth, 6 weeks
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 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 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
Berkeley, California, United States
Carson, California, United States
Fountain Valley, California, United States
Irvine, California, United States
Sunnyvale, California, United States
Danbury, Connecticut, United States
Fairfield, Connecticut, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, 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
Springfield, Illinois, United States
Scarborough, Maine, United States
Worcester, Massachusetts, United States
Southfield, Michigan, United States
Traverse City, Michigan, United States
Toms River, New Jersey, United States
Kingston, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Salisbury, North Carolina, United States
Columbus, Ohio, United States
Warwick, Rhode Island, United States
Brentwood, Tennessee, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Kirkland, Washington, United States
Spokane, Washington, United States
Pleven, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Clermont-Ferrand, , France
Marseille, , France
Nantes, , France
Pessac, , France
Strasbourg, , France
Toulouse, , France
Bangalore, , India
Hyderabad, , India
Karnataka, , India
Mangalore, , India
Mumbai, , India
Mumbai, , India
New Dalhi, , India
Pune, , India
Pune, , India
Tamil Nadu, , India
Tamil Nadu, , India
Visakhapatnam, , India
Kazan', , Russia
Kirov, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
Kharkiv, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Luhansk, , Ukraine
Lviv, , Ukraine
Vinnytsia, , Ukraine
Barnsley, , United Kingdom
Blackburn, , United Kingdom
Brighton, , United Kingdom
Dorset, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
North Shields, , United Kingdom
Salford, , United Kingdom
Countries
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Other Identifiers
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ACP-103-012
Identifier Type: -
Identifier Source: org_study_id
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