KW-6002 (istradefylline) did not meet its primary endpoint in patients with Parkinson's disease.-Kyowa Hakko Kirin.

Kyowa Hakko Kirin Co., Ltd. announced that top-line results of a global Phase III trial of istradefylline (generic name; code name, KW-6002) did not meet its primary endpoint in patients with Parkinson's disease. This study was to evaluate the efficacy of KW-6002 (20 mg or 40 mg once-daily treatment for 12 weeks) in patients with moderate to severe Parkinson's disease with "wearing-off phenomenon" on levodopa therapy, in comparison with placebo, and to assess the safety of both doses.

A trend toward greater reduction in the daily off-time compared with placebo was observed in the 20 mg and 40 mg KW-6002 groups throughout the evaluation period. However, there was no statistically significant difference in the primary outcome measure, i.e., the change from baseline in daily off-time, at Week 12 between the 20 mg or 40 mg KW-6002 group and the placebo group. In terms of safety, KW-6002 was well tolerated at both 20 and 40 mg doses.