{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T03:03:57Z","timestamp":1790996637098,"version":"4.1.0"},"reference-count":20,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,10,19]],"date-time":"2020-10-19T00:00:00Z","timestamp":1603065600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical","doi-asserted-by":"publisher","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/501100013170","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["movementdisorders.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Movement Disorders"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>This placebo\u2010controlled, randomized study evaluated the efficacy and safety of opicapone 25\u2010mg and 50\u2010mg tablets in Japanese levodopa\u2010treated patients with Parkinson's disease and motor fluctuations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Japanese adults (n = 437, age 39\u201383\u2009years) with Parkinson's disease (United Kingdom Parkinson's Disease Society criteria) received opicapone 25\u2010mg (n\u2009=\u2009145), opicapone 50\u2010mg (n = 145), or placebo (n = 147) tablets over the double\u2010blind treatment period (14\u201315\u2009weeks). The primary efficacy assessment was change in OFF\u2010time; secondary efficacy assessments included OFF\/ON\u2010time responders (\u22651\u2009hour change from baseline), total ON\u2010time, ON\u2010time with and without troublesome dyskinesia, and Unified Parkinson's Disease Rating Scale.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The least squares mean (standard error) change in OFF\u2010time from baseline to the last visit was \u22120.42 (0.21) hour for the placebo group, \u22121.16 (0.22) hour for the opicapone 25\u2009mg group, and \u22121.04 (0.21) hour for the opicapone 50\u2009mg group. The percentage of ON\u2010time responders, changes in total ON\u2010time\/ON\u2010time 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 (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05). Unified Parkinson's Disease Rating Scale III (at ON) was improved versus placebo in patients who received opicapone 50\u2009mg (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05). Adverse events were more common in patients treated with opicapone 25\u2009mg (60.0%) or opicapone 50\u2009mg (54.5%) versus placebo (48.3%). The most commonly reported adverse event was dyskinesia (placebo, 2.7%; opicapone 25\u2009mg, 9.0%; opicapone 50\u2009mg, 12.4%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In Japanese patients, both opicapone 25 and 50\u2009mg were significantly more effective than placebo with no dose\u2010dependent difference in efficacy, and both doses were well tolerated. \u00a9 2020 The Authors. <jats:italic>Movement Disorders<\/jats:italic> published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/mds.28322","type":"journal-article","created":{"date-parts":[[2020,10,19]],"date-time":"2020-10-19T13:34:57Z","timestamp":1603114497000},"page":"415-423","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":36,"title":["Randomized, Controlled Study of Opicapone in Japanese Parkinson's Patients with Motor Fluctuations"],"prefix":"10.1002","volume":"36","author":[{"given":"Atsushi","family":"Takeda","sequence":"first","affiliation":[{"name":"National Hospital Organization Sendai\u2010Nishitaga Hospital  Sendai Japan"},{"name":"Department of Cognitive &amp; Motor Aging Tohoku University, Graduate School of Medicine  Sendai Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1407-9640","authenticated-orcid":false,"given":"Ryosuke","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Neurology Kyoto University Graduate School of Medicine  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshio","family":"Tsuboi","sequence":"additional","affiliation":[{"name":"Department of Neurology Fukuoka University Hospital  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Nomoto","sequence":"additional","affiliation":[{"name":"Department of Neurology and Clinical Pharmacology Ehime University Graduate School of Medicine  Toon Japan"},{"name":"Department of Neurology Saiseikai Imabari Hospital  Imabari Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuya","family":"Maeda","sequence":"additional","affiliation":[{"name":"Division of Neurology and Gerontology, Department of Internal Medicine, School of Medicine Iwate Medical University  Shiwa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihisa","family":"Nishimura","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Ono Pharmaceutical Co., Ltd.  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