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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
298
10 mg, tablet, once daily by mouth, 6 weeks
40 mg, tablet, once daily by mouth, 6 weeks
tablet, once daily by mouth, 6 weeks
Antipsychotic Efficacy
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.
Time frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Motor Symptoms Change From Baseline (Negative = Improvement)
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.
Time frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Berkeley, California, United States
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Carson, California, United States
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Fountain Valley, California, United States
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Irvine, California, United States
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Sunnyvale, California, United States
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Danbury, Connecticut, United States
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Fairfield, Connecticut, United States
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Boca Raton, Florida, United States
...and 68 more locations