{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T05:27:25Z","timestamp":1773984445385,"version":"3.50.1"},"reference-count":41,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,3,4]],"date-time":"2020-03-04T00:00:00Z","timestamp":1583280000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,3,4]],"date-time":"2020-03-04T00:00:00Z","timestamp":1583280000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"BIAL - Portela & Ca, S.A.","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Transl Neurodegener"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>The efficacy and safety of opicapone, a once-daily catechol-O-methyltransferase inhibitor, have been established in two large randomized, placebo-controlled, multinational pivotal trials. Still, clinical evidence from routine practice is needed to complement the data from the pivotal trials.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>OPTIPARK (NCT02847442) was a prospective, open-label, single-arm trial conducted in Germany and the UK under clinical practice conditions. Patients with Parkinson\u2019s disease and motor fluctuations were treated with opicapone 50\u2009mg for 3 (Germany) or 6 (UK) months in addition to their current levodopa and other antiparkinsonian treatments. The primary endpoint was the Clinician\u2019s Global Impression of Change (CGI-C) after 3\u2009months. Secondary assessments included Patient Global Impressions of Change (PGI-C), the Unified Parkinson\u2019s Disease Rating Scale (UPDRS), Parkinson\u2019s Disease Questionnaire (PDQ-8), and the Non-Motor Symptoms Scale (NMSS). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>Of the 506 patients enrolled, 495 (97.8%) took at least one dose of opicapone. Of these, 393 (79.4%) patients completed 3\u2009months of treatment. Overall, 71.3 and 76.9% of patients experienced any improvement on CGI-C and PGI-C after 3\u2009months, respectively (full analysis set). At 6\u2009months, for UK subgroup only (<jats:italic>n<\/jats:italic>\u2009=\u200995), 85.3% of patients were judged by investigators as improved since commencing treatment. UPDRS scores at 3\u2009months showed statistically significant improvements in activities of daily living during OFF (mean\u2009\u00b1\u2009SD change from baseline: \u2212\u20093.0\u2009\u00b1\u20094.6, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001) and motor scores during ON (\u2212\u20094.6\u2009\u00b1\u20098.1, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001). The mean\u2009\u00b1\u2009SD improvements of \u2212\u20093.4\u2009\u00b1\u200912.8 points for PDQ-8 and -6.8\u2009\u00b1\u200919.7 points for NMSS were statistically significant versus baseline (both <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001). Most of TEAEs (94.8% of events) were of mild or moderate intensity. TEAEs considered to be at least possibly related to opicapone were reported for 45.1% of patients, with dyskinesia (11.5%) and dry mouth (6.5%) being the most frequently reported. Serious TEAEs considered at least possibly related to opicapone were reported for 1.4% of patients.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>Opicapone 50\u2009mg was effective and generally well-tolerated in PD patients with motor fluctuations treated in clinical practice.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>Registered in July 2016 at clinicaltrials.gov (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT02847442\">NCT02847442<\/jats:ext-link>).<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s40035-020-00187-1","type":"journal-article","created":{"date-parts":[[2020,3,4]],"date-time":"2020-03-04T11:03:08Z","timestamp":1583319788000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":52,"title":["Effectiveness and safety of opicapone in Parkinson\u2019s disease patients with motor fluctuations: the OPTIPARK open-label study"],"prefix":"10.1186","volume":"9","author":[{"name":"the OPTIPARK investigators","sequence":"first","affiliation":[]},{"given":"Heinz","family":"Reichmann","sequence":"first","affiliation":[]},{"given":"Andrew","family":"Lees","sequence":"additional","affiliation":[]},{"given":"Jos\u00e9-Francisco","family":"Rocha","sequence":"additional","affiliation":[]},{"given":"Diogo","family":"Magalh\u00e3es","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2446-5078","authenticated-orcid":false,"given":"Patr\u00edcio","family":"Soares-da-Silva","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2020,3,4]]},"reference":[{"key":"187_CR1","first-page":"472830","volume":"2011","author":"ER Appleman","year":"2011","unstructured":"Appleman ER, Stavitsky K, Cronin-Golomb A. 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All patients provided written informed consent.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"HR reports acting on Advisory Boards, gave lectures and received research grants from Abbott, Abbvie, Bayer Health Care, BIAL, Boehringer\/Ingelheim, Brittania, Cephalon, Desitin, GSK, Lundbeck, Medtronic, Merck-Serono, Novartis, Orion, Pfizer, TEVA, UCB Pharma, Valeant, and Zambon. AJL is funded by the Reta Lila Weston Institute of Neurological Studies, University College London, Institute of Neurology and reports consultancies from Britannia Pharmaceuticals and BIAL. He also reports grants and\/or research support from the Frances and Renee Hock Fund and honoraria from Britannia Pharmaceuticals, Profile Pharma, UCB, Roche, BIAL, STADA, Nordiclnfu Care, and NeuroDerm. JFR, DM and PSS are employed by BIAL - Portela & C\u00aa, S.A.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"9"}}