To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
459
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
Time frame: From first to last study drug dose plus 30 days
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, 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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Fresno, California, United States
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Irvine, California, United States
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La Habra, California, United States
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La Jolla, California, United States
...and 125 more locations