{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T05:48:53Z","timestamp":1788241733372,"version":"build-2803163510"},"reference-count":0,"publisher":"BMJ","funder":[{"DOI":"10.13039\/100006259","name":"Teva Pharmaceutical Industries","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006259","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Neurol Neurosurg Psychiatry"],"abstract":"Objective<\/jats:title>To evaluate the long-term safety and efficacy of deutetrabenazine in patients with tardive dyskinesia (TD).<\/jats:p><\/jats:sec>Method<\/jats:title>Patients with TD who completed the 12 week, phase 3, placebo-controlled trials were eligible to enter this open-label, single-arm study. The open-label study consisted of a 6 week dose-escalation phase and a long-term maintenance phase (clinic visits at Weeks 4, 6 and 15, and every 13 weeks until Week 106). Patients began deutetrabenazine at 12 mg\/day, titrating up to a dose that was tolerable and provided adequate dyskinesia control, based on investigator judgement, with a maximum allowed dose of 48 mg\/day (36 mg\/day for patients taking strong cytochrome P450 2D6 (CYP2D6) inhibitors). Safety measures included incidence of adverse events (AEs) and scales used to monitor parkinsonism, akathisia\/restlessness, anxiety, depression, suicidality and somnolence\/sedation. Efficacy endpoints included the change in Abnormal Involuntary Movement Scale (AIMS) score (items 1 to 7) from baseline and the proportion of patients rated as \u2018Much Improved\u2019 or \u2018Very Much Improved\u2019 on the Clinical Global Impression of Change.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 343 patients enrolled in the extension study, and there were 331 patient-years of exposure in this analysis. The exposure-adjusted incidence rates of AEs with long-term treatment were comparable to or lower than those observed in the phase 3 trials. The mean (SE) change in AIMS score was \u20134.9 (0.4) at Week 54 (n = 146), \u2013 6.3 (0.7) at Week 80 (n = 66) and \u20135.1 (2.0) at Week 106 (n = 8).<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Overall, long-term treatment with deutetrabenazine was efficacious, safe, and well tolerated in patients with TD.<\/jats:p><\/jats:sec>Trial registration number<\/jats:title>NCT02198794<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/jnnp-2018-319918","type":"journal-article","created":{"date-parts":[[2019,7,11]],"date-time":"2019-07-11T11:09:01Z","timestamp":1562843341000},"page":"jnnp-2018-319918","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia"],"prefix":"10.1136","clinical-trial-number":[{"clinical-trial-number":"nct02198794","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02198794","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Hubert H.","family":"Fernandez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Stamler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mat D.","family":"Davis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stewart A.","family":"Factor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Hauser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joohi","family":"Jimenez-Shahed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William G.","family":"Ondo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. Fredrik","family":"Jarskog","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott W.","family":"Woods","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danny","family":"Bega","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark S.","family":"LeDoux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Shprecher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen E.","family":"Anderson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,7,10]]},"container-title":["Journal of Neurology, Neurosurgery & Psychiatry"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/jnnp-2018-319918","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,9,26]],"date-time":"2020-09-26T04:46:38Z","timestamp":1601095598000},"score":1,"resource":{"primary":{"URL":"https:\/\/jnnp.bmj.com\/lookup\/doi\/10.1136\/jnnp-2018-319918"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7,10]]},"references-count":0,"alternative-id":["10.1136\/jnnp-2018-319918"],"URL":"https:\/\/doi.org\/10.1136\/jnnp-2018-319918","relation":{},"ISSN":["0022-3050","1468-330X"],"issn-type":[{"value":"0022-3050","type":"print"},{"value":"1468-330X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7,10]]}}}