{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T06:16:07Z","timestamp":1788243367888,"version":"build-2803163510"},"reference-count":31,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T00:00:00Z","timestamp":1761523200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T00:00:00Z","timestamp":1761523200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100018439","name":"SK Life Science","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100018439","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This randomized, double\u2010blind, placebo\u2010controlled study (NCT04557085), conducted in China, Japan, and the Republic of Korea, evaluated the efficacy and safety of adjunctive cenobamate in patients with uncontrolled focal seizures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adults 18\u201370\u2009years of age with \u22658 seizures (focal aware motor, focal impaired awareness, or focal to bilateral tonic\u2013clonic) during an 8\u2010week baseline, despite treatment with 1\u20133 antiseizure medications (ASMs), were randomized 1:1:1:1 to placebo or cenobamate 100, 200, or 400\u2009mg\/day. The study included an 18\u2010week titration phase and a 6\u2010week maintenance phase. The primary efficacy analysis was a hierarchical step\u2010down comparison of the percent change from baseline in 28\u2010day seizure frequency vs placebo during the maintenance phase for cenobamate 200, then 400, and then 100\u2009mg\/day.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 519 patients randomized, 446 received \u22651 dose of study drug and had \u22651 efficacy measure during the maintenance phase (placebo,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009117; 100\u2009mg\/day,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009113; 200\u2009mg\/day,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009113; and 400\u2009mg\/day,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009103). Median percent change in seizure frequency during the maintenance phase was \u221225.9% for placebo vs \u221242.6%, \u221278.3%, and \u2212100% for cenobamate 100, 200, and 400\u2009mg\/day, respectively (all\n                      <jats:italic>p<\/jats:italic>\n                      's\u2009\n                      <jats:italic>&lt;<\/jats:italic>\n                      \u2009.001). During the 12\u2010week period encompassing the last 6\u2009weeks of titration and the 6\u2010week maintenance phase (secondary outcome), the median percent change in seizure frequency was \u221220.1% for placebo vs \u221242.6%, \u221277.1%, and \u221289.2% for cenobamate 100, 200, and 400\u2009mg\/day, respectively. Seizure\u2010free rates during the maintenance phase were 2.6% of patients for placebo vs 12.4%, 30.1%, and 52.4% for cenobamate 100, 200, and 400\u2009mg\/day, respectively, and during the 12\u2010week period were 0.8% for placebo vs 8.5%, 19.7%, and 30.6% for the cenobamate groups. The most common treatment\u2010emergent adverse events in cenobamate patients (\u226520%) were dose\u2010related dizziness and somnolence.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Significance<\/jats:title>\n                    <jats:p>Cenobamate 100, 200, and 400\u2009mg\/day reduced focal seizures in Asian patients in a dose\u2010related fashion and was generally well tolerated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/epi.18698","type":"journal-article","created":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T13:20:35Z","timestamp":1761657635000},"page":"660-672","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["A randomized, double\u2010blind, placebo\u2010controlled, multicenter study to evaluate the efficacy and safety of adjunctive cenobamate in Asian patients with focal seizures"],"prefix":"10.1111","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1908-0699","authenticated-orcid":false,"given":"Sang Kun","family":"Lee","sequence":"first","affiliation":[{"name":"National University College of Medicine  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9265-7610","authenticated-orcid":false,"given":"Peimin","family":"Yu","sequence":"additional","affiliation":[{"name":"Huashan Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eunyeong","family":"Choe","sequence":"additional","affiliation":[{"name":"SK Biopharmaceuticals Co., Ltd.  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