{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T19:05:34Z","timestamp":1790881534844,"version":"4.1.0"},"reference-count":21,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2021,10,11]],"date-time":"2021-10-11T00:00:00Z","timestamp":1633910400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To report long\u2010term post hoc efficacy and safety data from 10 US study sites from an open\u2010label Phase 3\u00a0study of adjunctive cenobamate (NCT02535091).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with uncontrolled focal seizures taking stable doses of 1\u20133 antiseizure medications (ASMs) were administered increasing daily doses of cenobamate (12.5, 25, 50, 100, 150, 200\u00a0mg\/day) over 12\u00a0weeks at 2\u2010week intervals (target dose = 200\u00a0mg\/day). Further increases to 400\u00a0mg\/day by 50\u2010mg\/day increments biweekly were allowed during the maintenance phase. Dose adjustments of cenobamate and concomitant ASMs were allowed. Data were assessed until the last clinic visit on or after September 1, 2019.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 255 patients, 240 with focal aware motor, focal impaired awareness, or focal to bilateral tonic\u2013clonic seizure data while on treatment were evaluated (median [maximum] exposure = 30.2 [43.0] months across the entire study). Median baseline seizure frequency\/28\u00a0days was 2.8 (mean = 18.1). Of the 240 patients, 177 (73.8%) were continuing cenobamate treatment at data cutoff. The \u226550% responder rate for the total treatment duration was 71.7% (172\/240). During titration, the \u226550% responder rates were 48.1% during Weeks 1\u20134 (12.5\u201325\u00a0mg\/day cenobamate) and 61.7% during Weeks 5\u20138 (50\u2013100\u00a0mg\/day cenobamate). Among all patients who received a dose of cenobamate in the maintenance phase (<jats:italic>n<\/jats:italic>\u00a0=\u00a0214), 13.1% (28\/214) and 40.2% (86\/214) achieved 100% and \u226590% seizure reduction during their entire maintenance treatment duration (median = 29.5\u00a0months). Among all patients, 87 (36.3%) had any consecutive \u226512\u2010month duration of 100% seizure reduction. Common treatment\u2010emergent adverse events among all 240 patients included fatigue (34.6%), dizziness (32.1%), and somnolence (29.6%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>This post hoc analysis of a subset of patients from the long\u2010term open\u2010label study showed high rates of sustained 100% and \u226590% seizure reduction, with many achieving response early during titration. These findings suggest durable seizure frequency reduction with cenobamate in adults with uncontrolled focal seizures.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.17091","type":"journal-article","created":{"date-parts":[[2021,10,13]],"date-time":"2021-10-13T07:34:37Z","timestamp":1634110477000},"page":"3005-3015","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":66,"title":["Efficacy of cenobamate for uncontrolled focal seizures: Post hoc analysis of a Phase 3, multicenter, open\u2010label study"],"prefix":"10.1111","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0708-6006","authenticated-orcid":false,"given":"Michael R.","family":"Sperling","sequence":"first","affiliation":[{"name":"Thomas Jefferson University Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bassel","family":"Abou\u2010Khalil","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center Nashville Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sami","family":"Aboumatar","sequence":"additional","affiliation":[{"name":"Austin Epilepsy Care Center Austin Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Perminder","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Neuro Pain Medical Center Fresno California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Biton","sequence":"additional","affiliation":[{"name":"Arkansas Epilepsy Program Little Rock Arkansas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7244-3722","authenticated-orcid":false,"given":"Pavel","family":"Klein","sequence":"additional","affiliation":[{"name":"Mid\u2010Atlantic Epilepsy and Sleep Center Bethesda Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0338-6039","authenticated-orcid":false,"given":"Gregory L.","family":"Krauss","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4823-0537","authenticated-orcid":false,"given":"David G.","family":"Vossler","sequence":"additional","affiliation":[{"name":"University of Washington School of Medicine Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3146-986X","authenticated-orcid":false,"given":"Robert","family":"Wechsler","sequence":"additional","affiliation":[{"name":"Consultants in Epilepsy &amp; 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