Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of
istradefylline for reducing the mean total hours of awake time per day spent in the OFF state
in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet
entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses
of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks
and will have interim visits and end of treatment visit to assess the efficacy and safety of
istradefylline.
Phase:
Phase 3
Details
Lead Sponsor:
Kyowa Hakko Kirin Company, Limited Kyowa Kirin Co., Ltd.