4.3 Article

Long-term safety and efficacy of opicapone in Japanese Parkinson's patients with motor fluctuations

期刊

JOURNAL OF NEURAL TRANSMISSION
卷 128, 期 3, 页码 337-344

出版社

SPRINGER WIEN
DOI: 10.1007/s00702-021-02315-1

关键词

Japanese; Open-label; Opicapone; Parkinson’ s disease

资金

  1. Ono Pharmaceutical Co., Ltd., Osaka, Japan

向作者/读者索取更多资源

The double-blind part of the COMFORT-PD study in Japanese levodopa-treated patients with Parkinson's disease and motor fluctuations showed that both opicapone 25 and 50 mg were more effective than placebo. The 52-week open-label extension study demonstrated that opicapone 50 mg tablets were well tolerated and consistently reduced OFF-time in patients who completed the initial double-blind part of the study.
The double-blind part of the COMFORT-PD (COMt-inhibitor Findings from Opicapone Repeated Treatment for Parkinson's Disease) study in Japanese levodopa-treated patients with Parkinson's disease and motor fluctuations found that both opicapone 25 and 50 mg were significantly more effective than placebo. This 52-week open-label extension study evaluated the long-term safety and efficacy of opicapone 50 mg tablets in patients who completed the double-blind part of the COMFORT-PD study. Safety was monitored via adverse events, laboratory testing, and physical, cardiovascular and neurological examinations. Efficacy was primarily assessed by change in OFF-time. Secondary efficacy measures included: ON-time, percentage of OFF/ON-time responders, other outcomes from the double-blind part. 391/437 patients were transferred to the open-label extension period and included in the safety analysis set (full analysis set, n = 387; open-label completers, n = 316). Adverse events were frequently reported (n = 338, 86.4%), but < 50% were considered drug-related (39.9%) and few were considered serious (2.6%) or led to discontinuation (2.8%). Decreased OFF-time was consistently observed over the open-label period regardless of initial randomization. Change [LSM (SE)] in OFF-time from the open-label baseline to the last visit showed a persistent effect in patients initially randomized to opicapone 25 mg [- 0.37 (0.20) h, P = 0.0689] and opicapone 50 mg [- 0.07 (0.21) h, P = 0.6913] whereas opicapone 50 mg led to a statistically significant reduction in the previous placebo group [- 1.26 (0.19) h, P < 0.05]. Once-daily opicapone 50 mg was generally well tolerated and consistently reduced OFF-time over 52 weeks in Japanese levodopa-treated patients with motor fluctuations. Trial registration JapicCTI-153112; date of registration: December 25, 2015.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.3
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

暂无数据
暂无数据