Parkinson's Disease Clinical Trial
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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