{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T16:59:22Z","timestamp":1789664362349,"version":"4.0.1"},"reference-count":22,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,2,15]],"date-time":"2024-02-15T00:00:00Z","timestamp":1707955200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014605","name":"Sage Therapeutics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014605","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005614","name":"Biogen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005614","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["movementdisorders.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Movement Disorders"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>SAGE\u2010324\/BIIB124 is an investigational positive allosteric modulator of GABA<jats:sub>A<\/jats:sub> receptors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>KINETIC (NCT04305275), a double\u2010blind, randomized, placebo\u2010controlled, phase 2 study, evaluated SAGE\u2010324\/BIIB124 in individuals with essential tremor (ET).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Individuals aged 18 to 80\u2009years were randomly assigned 1:1 to orally receive 60\u2009mg of SAGE\u2010324\/BIIB124 or placebo once daily for 28\u2009days. The primary endpoint was change from baseline in The Essential Tremor Rating Assessment Scale\u2010Performance Subscale (TETRAS\u2010PS) Item 4 (upper\u2010limb tremor) at day 29 with SAGE\u2010324\/BIIB124 versus placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between May 2020 and February 2021, 69 U.S. participants were randomly assigned to receive SAGE\u2010324\/BIIB124 (n\u2009=\u200934) or placebo (n\u2009=\u200935). There was a significant reduction from baseline in TETRAS\u2010PS Item 4 at day 29 with SAGE\u2010324\/BIIB124 versus placebo (least squares mean [standard error]: \u20132.31 [0.401] vs. \u20131.24 [0.349], <jats:italic>P<\/jats:italic>\u2009=\u20090.0491). The most common treatment\u2010emergent adverse events included somnolence, dizziness, fatigue, and balance disorder.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These results support further development of SAGE\u2010324\/BIIB124 for potential ET treatment. \u00a9 2024 Sage Therapeutics, Inc and The Authors. <jats:italic>Movement Disorders<\/jats:italic> published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/mds.29731","type":"journal-article","created":{"date-parts":[[2024,2,15]],"date-time":"2024-02-15T04:54:27Z","timestamp":1707972867000},"page":"733-738","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A Randomized Phase 2 <scp>KINETIC<\/scp> Trial Evaluating <scp>SAGE<\/scp>\u2010324\/<scp>BIIB124<\/scp> in Individuals with Essential Tremor"],"prefix":"10.1002","volume":"39","author":[{"given":"Rodger J.","family":"Elble","sequence":"first","affiliation":[{"name":"Department of Neurology Southern Illinois University School of Medicine  Springfield Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William G.","family":"Ondo","sequence":"additional","affiliation":[{"name":"Department of Neurology Houston Methodist Hospital  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly E.","family":"Lyons","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Kansas Medical Center  Kansas City Kansas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Qin","sequence":"additional","affiliation":[{"name":"Sage Therapeutics, Inc  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Svetlana","family":"Garafola","sequence":"additional","affiliation":[{"name":"Sage Therapeutics, Inc  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie","family":"Hersh","sequence":"additional","affiliation":[{"name":"Biogen Inc.  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"TinaMarie","family":"Lieu","sequence":"additional","affiliation":[{"name":"Sage Therapeutics, Inc  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitrios","family":"Arkilo","sequence":"additional","affiliation":[{"name":"Sage Therapeutics, Inc  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosalind","family":"Chuang","sequence":"additional","affiliation":[{"name":"Biogen Inc.  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kemi","family":"Bankole","sequence":"additional","affiliation":[{"name":"Sage Therapeutics, Inc  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3176-6466","authenticated-orcid":false,"given":"Rajesh","family":"Pahwa","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Kansas Medical Center  Kansas City Kansas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,2,15]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/mds.27121"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.5334\/tohm.632"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.94.15_supplement.4458"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2022.891446"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.parkreldis.2015.04.019"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.4137\/JCNSD.S6561"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e318236f0fd"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.5334\/tohm.229"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/bs.irn.2022.02.007"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.brainres.2013.07.011"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awr301"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.5b00032"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuropharm.2016.10.010"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tips.2016.04.003"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.94.15_supplement.4499"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.5334\/tohm.455"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jns.2022.120202"},{"issue":"1","key":"e_1_2_10_19_1","article-title":"An open\u2010label, phase 1b study of the neuroactive steroid GABAA receptor positive allosteric modulator SAGE\u2010324 in essential tremor","volume":"35","author":"Colquhoun H","year":"2020","journal-title":"Mov Disord"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ncl.2020.01.002"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopsych.2021.07.017"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuropharm.2020.108333"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.expneurol.2017.07.013"}],"container-title":["Movement Disorders"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/movementdisorders.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/mds.29731","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,20]],"date-time":"2025-10-20T08:42:09Z","timestamp":1760949729000},"score":1,"resource":{"primary":{"URL":"https:\/\/movementdisorders.onlinelibrary.wiley.com\/doi\/10.1002\/mds.29731"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,15]]},"references-count":22,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,4]]}},"alternative-id":["10.1002\/mds.29731"],"URL":"https:\/\/doi.org\/10.1002\/mds.29731","archive":["Portico"],"relation":{},"ISSN":["0885-3185","1531-8257"],"issn-type":[{"value":"0885-3185","type":"print"},{"value":"1531-8257","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,15]]},"assertion":[{"value":"2023-07-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-10","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}