{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T18:32:12Z","timestamp":1791484332172,"version":"4.3.4"},"reference-count":26,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2023,8,24]],"date-time":"2023-08-24T00:00:00Z","timestamp":1692835200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["movementdisorders.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Movement Disord Clin Pract"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Tourette syndrome (TS) is a neurodevelopmental disorder characterized by motor and phonic tics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the safety and efficacy of deutetrabenazine (Teva Neuroscience, Inc, Parsippany, NJ), a vesicular monoamine transporter 2 inhibitor, in children and adolescents with TS.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Alternatives for Reducing Tics in TS (ARTISTS) open\u2010label extension (OLE) (NCT03567291) was a 54\u2010week, global, phase 3, open\u2010label extension study of deutetrabenazine (6\u201348\u2009mg daily) conducted May 28, 2018 to April 3, 2020 with a 2\u2010week randomized withdrawal period. Participants (6\u201316\u2009years of age) had TS and active tics causing distress or impairment. Safety (primary outcome) was assessed by treatment\u2010emergent adverse events (TEAEs) and clinical laboratory testing. Efficacy was measured by the Yale Global Tic Severity Scale\u2010Total Tic Score (YGTSS\u2010TTS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The intent\u2010to\u2010treat population (228 participants; mean age, 12.0\u2009years; 79.8% male; 86.4% white) had a median (range) duration of exposure of 28.4 (0.3\u201352.9) weeks. Of 227 participants in the safety analysis, 161 (70.9%) reported \u22651 TEAE (exposure\u2010adjusted incidence rate, 2.77\/patient\u2010year), of which 95 (41.9%) were treatment related. The most frequently reported TEAEs were headaches, somnolence, nasopharyngitis, weight increases, and anxiety. No additional safety signals were observed. Worsening of YGTSS\u2010TTS after the 2\u2010week randomized withdrawal was not statistically significant (least squares mean difference, \u22120.4; <jats:italic>P<\/jats:italic>\u2009=\u20090.78). Several exploratory measures showed sustained improvement throughout the treatment periods.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In this long\u2010term, open\u2010label trial, deutetrabenazine was well tolerated with low frequency of TEAEs. There was no significant difference in tics between treatment arms during the 2\u2010week randomized withdrawal period, however, descriptive statistics and comparison with baseline showed a numeric improvement in tics, quality of life, and other measures.<\/jats:p><\/jats:sec>","DOI":"10.1002\/mdc3.13849","type":"journal-article","created":{"date-parts":[[2023,7,29]],"date-time":"2023-07-29T03:50:55Z","timestamp":1690602655000},"page":"1388-1398","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Safety and Efficacy of Long\u2010Term Deutetrabenazine Use in Children and Adolescents with Tics Associated with Tourette Syndrome: An Open\u2010Label Extension Study"],"prefix":"10.1002","volume":"10","author":[{"given":"Joseph","family":"Jankovic","sequence":"first","affiliation":[{"name":"Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology Baylor College of Medicine  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Coffey","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences, Child and Adolescent Psychiatry University of Miami Miller School of Medicine  Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel O.","family":"Claassen","sequence":"additional","affiliation":[{"name":"Department of Neurology, Division of Behavioral and Cognitive Neurology Vanderbilt University Medical Center  Nashville Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joohi","family":"Jimenez\u2010Shahed","sequence":"additional","affiliation":[{"name":"Movement Disorders Neuromodulation &amp; Brain Circuit Therapeutics, Departments of Neurology and Neurosurgery Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry J.","family":"Gertz","sequence":"additional","affiliation":[{"name":"Nuvelution TS Pharma Inc.  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A.","family":"Garofalo","sequence":"additional","affiliation":[{"name":"Nuvelution TS Pharma Inc.  San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Stamler","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D, Inc.  La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Wieman","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D, Inc.  West Chester Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juha\u2010Matti","family":"Savola","sequence":"additional","affiliation":[{"name":"Teva Pharmaceuticals International GmbH  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eran","family":"Harary","sequence":"additional","affiliation":[{"name":"Innovative Medicines, Global Clinical Development Teva Pharmaceutical Industries Ltd.  Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Alexander","sequence":"additional","affiliation":[{"name":"Global Medical Affairs Teva Branded Pharmaceutical Products R&amp;D, Inc.  West Chester Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hadas","family":"Barkay","sequence":"additional","affiliation":[{"name":"Innovative Medicines, Global Clinical Development Teva Pharmaceutical Industries Ltd.  Netanya Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark Forrest","family":"Gordon","sequence":"additional","affiliation":[{"name":"Innovative Medicines, Global Clinical Development Teva Branded Pharmaceutical Products R&amp;D, Inc.  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