The primary objective is to demonstrate that the investigational new drug, ACP-103, is well tolerated by, and will not worsen parkinsonism in, patients with Parkinson's disease and psychosis. The secondary objectives are to determine whether ACP-103 will ameliorate psychosis in patients with Parkinson's disease and whether ACP-103 is safe in Parkinson's disease patients taking multiple anti-parkinsonian medications.
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial of four weeks of ACP-103 treatment of psychosis in Parkinson's disease, with four weeks follow-up. A total of 60 patients meeting entrance criteria will be randomly assigned to receive placebo (30 patients) or active drug (30 patients). Subjects will take study drug daily starting on Day 1. Dose escalations can occur on Study Days 8 and 15 only, and patients will receive a stable daily dosage from Day 16 until Day 28. Single step dose reductions are allowed during that period for adverse events or intolerance. Patients will be evaluated at screening/baseline and at Study Days 1, 8, 15, 28, and 57 by raters blinded to the treatment. The major response variable will be motoric tolerability. Secondary response variables will be efficacy against psychosis and safety. Currently, there are no approved drugs for this indication in the United States. Psychotic symptoms in Parkinson's disease patients are almost always stable, often non-threatening, and rarely paranoid or violent in content. The trial includes the requirement that each patient enrolled has a reliable caretaker who will accompany the patient to each visit who can reliably report on the patient's daily level of function. These factors argue for the safe inclusion of a four-week period of placebo treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Sunnyvale, California, United States
Unnamed facility
Danbury, Connecticut, United States
ACP-103 is an effective treatment for Parkinson's Disease with psychosis
ACP-103 does not cause worsening of motor function in Parkinson's Disease
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Unnamed facility
Pompano Beach, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Kansas City, Kansas, United States
Unnamed facility
Elkridge, Maryland, United States
Unnamed facility
Albany, New York, United States
Unnamed facility
Asheville, North Carolina, United States
...and 3 more locations