Atsushi Takeda1,2, Ryosuke Takahashi3, Yoshio Tsuboi4, Masahiro Nomoto5,6, Tetsuya Maeda7, Akihisa Nishimura8, Kazuo Yoshida8, Nobutaka Hattori9. 1. National Hospital Organization, Sendai-Nishitaga Hospital, Sendai, Japan. 2. Department of Cognitive & Motor Aging, Tohoku University, Graduate School of Medicine, Sendai, Japan. 3. Department of Neurology, Kyoto University Graduate School of Medicine, Kyoto, Japan. 4. Department of Neurology, Fukuoka University Hospital, Fukuoka, Japan. 5. Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Toon, Japan. 6. Department of Neurology, Saiseikai Imabari Hospital, Imabari, Japan. 7. Division of Neurology and Gerontology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Shiwa, Japan. 8. Department of Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka, Japan. 9. Department of Neurology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
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 < 0.05). Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50 mg (P < 0.05). Adverse events were more common in patients treated with opicapone 25 mg (60.0%) or opicapone 50 mg (54.5%) versus placebo (48.3%). The most commonly reported adverse event was dyskinesia (placebo, 2.7%; opicapone 25 mg, 9.0%; opicapone 50 mg, 12.4%). CONCLUSIONS: In Japanese patients, both opicapone 25 and 50 mg were significantly more effective than placebo with no dose-dependent difference in efficacy, and both doses were well tolerated.
RCT Entities:
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 < 0.05). Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50 mg (P < 0.05). Adverse events were more common in patients treated with opicapone 25 mg (60.0%) or opicapone 50 mg (54.5%) versus placebo (48.3%). The most commonly reported adverse event was dyskinesia (placebo, 2.7%; opicapone 25 mg, 9.0%; opicapone 50 mg, 12.4%). CONCLUSIONS: In Japanese patients, both opicapone 25 and 50 mg were significantly more effective than placebo with no dose-dependent difference in efficacy, and both doses were well tolerated.
Authors: Kelly Posner; Gregory K Brown; Barbara Stanley; David A Brent; Kseniya V Yershova; Maria A Oquendo; Glenn W Currier; Glenn A Melvin; Laurence Greenhill; Sa Shen; J John Mann Journal: Am J Psychiatry Date: 2011-12 Impact factor: 18.112
Authors: Diego Santos García; Gustavo Fernández Pajarín; Juan Manuel Oropesa-Ruiz; Francisco Escamilla Sevilla; Raúl Rashid Abdul Rahim López; José Guillermo Muñoz Enríquez Journal: Brain Sci Date: 2022-03-12