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

SUBMITTER: Takeda A 

PROVIDER: S-EPMC7983910 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature