{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T16:27:10Z","timestamp":1776270430276,"version":"3.50.1"},"reference-count":34,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2022,9,17]],"date-time":"2022-09-17T00:00:00Z","timestamp":1663372800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100012351","name":"Mitsubishi Tanabe Pharma Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100012351","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Psychiatry Clin Neurosci"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>Valbenazine is approved in the US for treatment of tardive dyskinesia (TD); however, efficacy\/safety data in Asian populations are lacking. We assessed the efficacy\/safety of valbenazine in Japanese patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This phase II\/III, multicenter, randomized, double\u2010blind, placebo\u2010controlled study (NCT03176771) included adult psychiatric patients with TD, who were randomly allocated to receive placebo or valbenazine (once\u2010daily 40\u2010 or 80\u2010mg) for a 6\u2010week, double\u2010blind period, after which the placebo group was switched to valbenazine for a 42\u2010week extension. The primary endpoint was change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score at Week 6; clinical global impression of improvement of TD (CGI\u2010TD) was also assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 256 patients, 86, 85, and 85 were allocated to the 40\u2010mg valbenazine, 80\u2010mg valbenazine, and placebo groups, respectively. Least\u2010squares mean (95% confidence interval) change from baseline in AIMS score at Week 6 was \u22122.3 (\u22123.0 to \u22121.7) in the valbenazine 40\u2010mg group, \u22123.7 (\u22124.4 to \u22123.0) in the 80\u2010mg group, and \u22120.1 (\u22120.8 to 0.5) in the placebo group; both treatment groups showed statistically significant improvements <jats:italic>vs.<\/jats:italic> placebo. Patients switched to valbenazine at Week 6 showed similar improvements in AIMS scores, which were maintained to Week 48. Improvements in CGI\u2010TD scores were observed for both treatment groups <jats:italic>vs.<\/jats:italic> placebo. Incidence of adverse events was highest in the 80\u2010mg group; common events included nasopharyngitis, somnolence, schizophrenia worsening, hypersalivation, insomnia, and tremor.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The efficacy\/safety profile of valbenazine was similar to that of previous clinical trials, supporting its use for TD treatment in Japanese patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pcn.13455","type":"journal-article","created":{"date-parts":[[2022,8,13]],"date-time":"2022-08-13T09:43:46Z","timestamp":1660383826000},"page":"560-569","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Efficacy and safety of valbenazine in Japanese patients with tardive dyskinesia: A multicenter, randomized, double\u2010blind, placebo\u2010controlled study (<scp>J\u2010KINECT<\/scp>)"],"prefix":"10.1111","volume":"76","author":[{"given":"Jun","family":"Horiguchi","sequence":"first","affiliation":[{"name":"Department of Psychiatry Shimane University Faculty of Medicine  Izumo Shimane Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0736-7070","authenticated-orcid":false,"given":"Koichiro","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Neuropsychiatry Kyorin University School of Medicine  Mitaka Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuoki","family":"Kondo","sequence":"additional","affiliation":[{"name":"Ikuyaku, Integrated Value Development Division Mitsubishi Tanabe Pharma Corporation  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsushi","family":"Iwatake","sequence":"additional","affiliation":[{"name":"Ikuyaku, Integrated Value Development Division Mitsubishi Tanabe Pharma Corporation  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hajime","family":"Sakamoto","sequence":"additional","affiliation":[{"name":"Ikuyaku, Integrated Value Development Division Mitsubishi Tanabe Pharma Corporation  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Susuta","sequence":"additional","affiliation":[{"name":"Ikuyaku, Integrated Value Development Division Mitsubishi Tanabe Pharma Corporation  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideaki","family":"Masui","sequence":"additional","affiliation":[{"name":"Ikuyaku, Integrated Value Development Division Mitsubishi Tanabe Pharma Corporation  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8875-7598","authenticated-orcid":false,"given":"Yumi","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Ikuyaku, Integrated Value Development Division Mitsubishi Tanabe Pharma Corporation  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,9,17]]},"reference":[{"key":"e_1_2_11_2_1","first-page":"162","article-title":"Medication induced tardive dyskinesia: a review and update","volume":"17","author":"Cornett EM","year":"2017","journal-title":"Ochsner J."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/YCO.0b013e3282f53132"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/pcn.12270"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jns.2018.02.015"},{"key":"e_1_2_11_6_1","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1111\/j.1742-1241.1996.tb09518.x","article-title":"Life\u2010threatening tardive dyskinesia","volume":"50","author":"Chiu HF","year":"1996","journal-title":"Br. 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