{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T04:22:20Z","timestamp":1793766140533,"version":"4.6.1"},"reference-count":42,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T00:00:00Z","timestamp":1787875200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T00:00:00Z","timestamp":1787875200000},"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"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study was undertaken to assess long\u2010term efficacy, safety, and tolerability of adjunctive cenobamate in an open\u2010label extension (OLE) of a randomized, double\u2010blind, placebo\u2010controlled, dose\u2013response study (NCT04557085; YKP3089C035 [Study C035]) in Asian patients with uncontrolled focal seizures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Patients 18\u201370\u2009years old with uncontrolled focal seizures despite treatment with 1\u20133 antiseizure medications who completed the 24\u2010week double\u2010blind treatment period (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009425) at cenobamate doses of 100, 200, or 400\u2009mg\/day or placebo could enter a 52\u2010week OLE. All patients were converted to a cenobamate dose of 400\u2009mg\/day during a 20\u2010week double\u2010blind conversion phase and then entered a 32\u2010week open\u2010label maintenance phase at a starting dose of 300\u2009mg\/day.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among the 410 patients who entered the double\u2010blind conversion phase, 357 (263 and 94 originally randomized to cenobamate and placebo, respectively) entered the OLE maintenance phase. The median percent focal seizure frequency reduction from double\u2010blind baseline for patients who received at least one dose of cenobamate during the 32\u2010week maintenance phase was 83.6%. The percent of patients achieving \u226550% and 100% responses during the maintenance phase was 75.1% and 25.5%, respectively. Among patients entering the OLE, 84.6% (347\/410) completed the 52\u2009weeks of treatment with cenobamate. The most commonly occurring treatment\u2010emergent adverse events (TEAEs) during the entire OLE were dizziness, somnolence, \u03b3\u2010glutamyl transferase (GGT) increase, and COVID\u201019 infection. GGT increase was not associated with any clinically significant findings. Serious TEAEs occurred in 11.7% of patients (48\/410). There were no deaths and no cases of DRESS (drug reaction with eosinophilia and systemic symptoms) syndrome reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Significance<\/jats:title>\n                    <jats:p>The high long\u2010term seizure frequency reductions, including a 100% responder rate of 25.5%, were consistent with previous long\u2010term cenobamate efficacy. The OLE safety profile was also generally consistent with the known cenobamate safety profile, with no new safety signals identified. These results support the use of cenobamate in adult Asian patients with uncontrolled focal seizures.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/epi.70459","type":"journal-article","created":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T13:55:25Z","timestamp":1787925325000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Long\u2010term efficacy of adjunctive cenobamate: Open\u2010label extension of a randomized, placebo\u2010controlled study in a multinational Asian population"],"prefix":"10.1002","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.  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