Research Study Title: A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson’s Disease
Funded by: Kyowa Pharmaceutical, Inc.
Clinical Trial Investigator Name: Cindy Zadikoff, MD
Clinical Trial Description:
This is a Phase 3, 12-week, double-blind, placebo-controlled, randomized, multicenter research study to evaluate the efficacy and safety of istradefylline 20 and 40 mg/d compared to placebo in patients with moderate to severe PD with motor fluctuations and dyskinesia on levodopa/carbidopa therapy.
The primary objective of the study is to establish the efficacy of istradefylline 20 and 40 milligram/day (mg/d) for reducing the total hours per day of OFF time in patients with moderate to severe Parkinson’s Disease (PD) with motor fluctuations and dyskinesia on levodopa/carbidopa therapy.
Clinical Trial Eligibility Criteria:
- Diagnosis of Parkinson’s Disease
- Motor fluctuations and dyskinesia (involuntary movements)
- Levodopa therapy for at least 1 year; currently taking carbidopa/levodopa with a total daily levodopa dosage of at least 400 mg, or who have documented evidence of intolerance to this dose
- No changes in PD medications for at least 4 weeks before SCN/BSL visit
- Documented end-of-dose wearing-off and levodopa-induced dyskinesia
Research Study Visits: 7 Clinic Visits & 1 telephone follow-up (12 wks)
Treatment: Istradefylline (20 and 40 mg/d) or placebo
Compensation: $75 for each study visit.
IRB Project #: STU00085134
ALL STUDY RELATED MEDICATION/PROCEDURES ARE FREE OF CHARGE.
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