Randomized, Controlled Study of Opicapone in Japanese Parkinson's Patients with Motor Fluctuations

ABSTRACT Objectives This placebo‐controlled, randomized study evaluated the efficacy and safety of opicapone 25‐mg and 50‐mg tablets in Japanese levodopa‐treated patients with Parkinson's disease and motor fluctuations. Methods Japanese adults (n = 437, age 39–83 years) with Parkinson's disease (United Kingdom Parkinson's Disease Society criteria) received opicapone 25‐mg (n = 145), opicapone 50‐mg (n = 145), or placebo (n = 147) tablets over the double‐blind treatment period (14–15 weeks). The primary efficacy assessment was change in OFF‐time; secondary efficacy assessments included OFF/ON‐time responders (≥1 hour change from baseline), total ON‐time, ON‐time with and without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale. Results The least squares mean (standard error) change in OFF‐time from baseline to the last visit was −0.42 (0.21) hour for the placebo group, −1.16 (0.22) hour for the opicapone 25 mg group, and −1.04 (0.21) hour for the opicapone 50 mg group. The percentage of ON‐time responders, changes in total ON‐time/ON‐time without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale II (at OFF) all showed statistically significant improvements versus placebo for both opicapone tablet doses (P