{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T01:46:17Z","timestamp":1791942377563,"version":"4.3.4"},"reference-count":32,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,1,10]],"date-time":"2025-01-10T00:00:00Z","timestamp":1736467200000},"content-version":"vor","delay-in-days":9,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Euro J of Neurology"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Catechol\u2010O\u2010methyl transferase (COMT) inhibitors are routinely used to manage motor fluctuations in Parkinson's disease (PD). We assessed the effect of opicapone on motor symptom severity in levodopa\u2010treated patients without motor complications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a randomized, double\u2010blind, 24\u2010week, placebo\u2010controlled study of opicapone 50\u2009mg as adjunct to levodopa (NCT04978597). Levodopa\u2010treated patients without motor complications were randomized to 24\u2009weeks of double\u2010blind treatment with adjunct opicapone 50\u2009mg or matching placebo. The primary efficacy endpoint was the mean change from baseline to week 24 in Movement Disorder Society\u2010Unified Parkinson's Disease Rating Scale Part III (MDS\u2010UPDRS\u2010III) total score.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 355 patients were randomized (opicapone 50\u2009mg <jats:italic>n<\/jats:italic>\u2009=\u2009177, placebo <jats:italic>n<\/jats:italic>\u2009=\u2009178) and 322 (91%) completed the double\u2010blind period. The adjusted mean [95% CI] change from baseline to week 24 in MDS\u2010UPDRS\u2010III subscore was \u22126.5 [\u22127.9, \u22125.2] in the opicapone group versus \u22124.3 [\u22125.7, 3.0] in the placebo group resulting in a significant difference of \u22122.2 [\u22123.9, \u22120.5] favoring opicapone (<jats:italic>p<\/jats:italic>\u2009=\u20090.010). There was no difference in the incidence of patients who developed motor complications (5.5% with opicapone vs. 9.8% with placebo) and the incidence of adverse events considered related to study medication was similar between groups (opicapone 10.2% vs. placebo 13.5%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Treatment with once\u2010daily adjunct opicapone was well tolerated, improved motor severity, and did not induce the development of motor complications. These results support the clinical usefulness of opicapone in the management of PD patients without motor complications.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ene.16420","type":"journal-article","created":{"date-parts":[[2025,1,10]],"date-time":"2025-01-10T08:39:38Z","timestamp":1736498378000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Opicapone as adjunct to levodopa in treated Parkinson's disease without motor complications: A randomized clinical trial"],"prefix":"10.1111","volume":"32","author":[{"given":"Joaquim J.","family":"Ferreira","sequence":"first","affiliation":[{"name":"IMM \u2013 Instituto de Medicina Molecular Jo\u00e3o Lobo Antunes, Faculdade de Medicina Universidade Lisboa  Lisbon Portugal"},{"name":"CNS \u2013 Campus Neurol\u00f3gico  Torres Vedras 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Neuroscience University of Padua  Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joana","family":"Moreira","sequence":"additional","affiliation":[{"name":"BIAL \u2013 Portela &amp; C<sup>a<\/sup> S.A  Coronado Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillermo","family":"Castilla\u2010Fern\u00e1ndez","sequence":"additional","affiliation":[{"name":"BIAL R&amp;D Investments  Coronado Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2611-4850","authenticated-orcid":false,"given":"Jos\u00e9\u2010Francisco","family":"Rocha","sequence":"additional","affiliation":[{"name":"BIAL \u2013 Portela &amp; C<sup>a<\/sup> S.A  Coronado Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joerg","family":"Holenz","sequence":"additional","affiliation":[{"name":"BIAL \u2013 Portela &amp; C<sup>a<\/sup> S.A  Coronado 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