Nobutaka Hattori1, Yoshio Tsuboi2, Akihiko Yamamoto3, Yuji Sasagawa4, Masahiro Nomoto5. 1. Department of Neurology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan. Electronic address: nhattori@juntendo.ac.jp. 2. Department of Neurology, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. Electronic address: tsuboi@cis.fukuoka-u.ac.jp. 3. Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: akihiko.yamamoto@meiji.com. 4. Meiji Seika Pharma Co., Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, 104-8002, Japan. Electronic address: yuuji.sasagawa@meiji.com. 5. Department of Neurology and Clinical Pharmacology, Graduate School of Medicine, Ehime University, Shizugawa, Tohon, Ehime, 791-0295, Japan; Saiseikai Imabari Center for Health and Welfare, 7-6-1 Kitamura, Imabari, Ehime, 799-1592, Japan. Electronic address: nomoto@m.ehime-u.ac.jp.
Abstract
INTRODUCTION:Safinamide is a reversible and selective monoamine oxidase-B (MAO-B) and sodium channel inhibitor with demonstrated efficacy in mid-to late-stage Parkinson's disease (PD) as an adjunct to l-DOPA. This study aimed to confirm the efficacy and safety of safinamide in PD patients with wearing-off. METHODS: This 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study included Japanese PD patients with wearing-off on l-DOPA treatment. Patients were randomized to receive placebo (P), safinamide 50 mg/day (S50), or safinamide 100 mg/day (S100). The primary endpoint was the change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time). Other measures included the changes in mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index. RESULTS:A total of 406 subjects were randomized, of whom 349 completed the study. Baseline characteristics were balanced. Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group. Changes from baseline in mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part I also showed significant improvements. Adverse events occurred in 58.9%, 60.2%, and 61.4% of the P, S50, and S100 groups, respectively. The most common adverse drug reactions were dyskinesias (2.1%, 8.3%, and 10.6%) and visual hallucinations (1.4%, 3.0%, and 4.5%). CONCLUSION: As an adjunct to l-DOPA, safinamide safely increased ON-time and improved PD symptoms/signs in PD patients with wearing-off.
RCT Entities:
INTRODUCTION:Safinamide is a reversible and selective monoamine oxidase-B (MAO-B) and sodium channel inhibitor with demonstrated efficacy in mid-to late-stage Parkinson's disease (PD) as an adjunct to l-DOPA. This study aimed to confirm the efficacy and safety of safinamide in PDpatients with wearing-off. METHODS: This 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study included Japanese PDpatients with wearing-off on l-DOPA treatment. Patients were randomized to receive placebo (P), safinamide 50 mg/day (S50), or safinamide 100 mg/day (S100). The primary endpoint was the change from baseline in mean daily ON-time without troublesome dyskinesias (ON-time). Other measures included the changes in mean daily OFF-time, the unified Parkinson's disease rating scale (UPDRS) score, and the PDQ-39 summary index. RESULTS: A total of 406 subjects were randomized, of whom 349 completed the study. Baseline characteristics were balanced. Differences in the change of mean daily ON-time at Week 24 compared with the P group were 1.39 h (p = 0.0002) in the S50 group and 1.66 h (p < 0.0001) in the S100 group. Changes from baseline in mean daily OFF-time, UPDRS Part II total score (OFF phase), UPDRS Part III total score (ON phase), and UPDRS Part I also showed significant improvements. Adverse events occurred in 58.9%, 60.2%, and 61.4% of the P, S50, and S100 groups, respectively. The most common adverse drug reactions were dyskinesias (2.1%, 8.3%, and 10.6%) and visual hallucinations (1.4%, 3.0%, and 4.5%). CONCLUSION: As an adjunct to l-DOPA, safinamide safely increased ON-time and improved PD symptoms/signs in PDpatients with wearing-off.
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Authors: Sotirios Grigoriou; Pablo Martínez-Martín; K Ray Chaudhuri; Katarina Rukavina; Valentina Leta; Denise Hausbrand; Björn Falkenburger; Per Odin; Heinz Reichmann Journal: Brain Behav Date: 2021-09-03 Impact factor: 2.708