{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T23:28:16Z","timestamp":1781220496278,"version":"3.54.1"},"reference-count":26,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,2,16]],"date-time":"2015-02-16T00:00:00Z","timestamp":1424044800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2015,4]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the efficacy and safety of eslicarbazepine acetate (<jats:styled-content style=\"fixed-case\">ESL<\/jats:styled-content>) as monotherapy in North American patients with partial\u2010onset seizures (<jats:styled-content style=\"fixed-case\">POS<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicenter, randomized, double\u2010blind \u201cwithdrawal to monotherapy\u201d study used historical control data as the comparator. Adults with <jats:styled-content style=\"fixed-case\">POS<\/jats:styled-content> medically uncontrolled by one to two antiepileptic drugs gradually converted to <jats:styled-content style=\"fixed-case\">ESL<\/jats:styled-content> monotherapy. Following an 8\u2010week baseline period, patients were randomized 2:1 to receive <jats:styled-content style=\"fixed-case\">ESL<\/jats:styled-content> 1,600\u00a0mg (n\u00a0=\u00a0128) or 1,200\u00a0mg <jats:styled-content style=\"fixed-case\">QD<\/jats:styled-content> (n\u00a0=\u00a065) for 18\u00a0weeks. The primary end point was the proportion of patients meeting predefined exit criteria (signifying worsening seizure control). Treatment was considered effective if the 95% upper confidence limit (<jats:styled-content style=\"fixed-case\">UCL<\/jats:styled-content>) for the Kaplan\u2010Meier estimated exit rate was lower than the exit rate threshold calculated from the historical control (65.3%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Kaplan\u2010Meier estimated exit rates were: <jats:styled-content style=\"fixed-case\">ESL<\/jats:styled-content> 1,600\u00a0mg, 28.7% (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 21.2\u201338.1%) and 1,200\u00a0mg, 44.4% (32.5\u201358.3%). The difference between doses was not significant (p\u00a0=\u00a00.07). For both doses, the 95% <jats:styled-content style=\"fixed-case\">UCL<\/jats:styled-content>s for the exit rate were \u02c265.3%; <jats:styled-content style=\"fixed-case\">ESL<\/jats:styled-content> monotherapy was considered superior to the historical control. There was no statistically significant increase in the risk of study exit related to carbamazepine use. Nine (7.6%) and five patients (8.3%) remained seizure\u2010free during the 10\u2010week monotherapy period, while taking <jats:styled-content style=\"fixed-case\">ESL<\/jats:styled-content> 1,600 and 1,200\u00a0mg, respectively. The reductions in median standardized seizure frequency (seizures per 28\u00a0days) between baseline and the 18\u2010week treatment period were: <jats:styled-content style=\"fixed-case\">ESL<\/jats:styled-content> 1,600\u00a0mg, 42% and 1,200\u00a0mg, 31%. Treatment\u2010emergent adverse events (<jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s) occurring in \u226510% of patients were dizziness, headache, fatigue, somnolence, nausea, and nasopharyngitis. The <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content> most frequently leading to discontinuation was hyponatremia (2.1%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">ESL<\/jats:styled-content> was efficacious and well tolerated as monotherapy in North American patients, and led to a reduction in seizure frequency. Exit rates for <jats:styled-content style=\"fixed-case\">ESL<\/jats:styled-content> 1,600 and 1,200\u00a0mg <jats:styled-content style=\"fixed-case\">QD<\/jats:styled-content> were superior to the historical control; the difference in exit rates between doses was not statistically significant.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.12934","type":"journal-article","created":{"date-parts":[[2015,2,16]],"date-time":"2015-02-16T04:52:58Z","timestamp":1424062378000},"page":"546-555","source":"Crossref","is-referenced-by-count":70,"title":["Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial\u2010onset seizures: A randomized historical\u2010control phase <scp>III<\/scp> study based in North America"],"prefix":"10.1111","volume":"56","author":[{"given":"Michael R.","family":"Sperling","sequence":"first","affiliation":[{"name":"Thomas Jefferson University Philadelphia Pennsylvania U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jay","family":"Harvey","sequence":"additional","affiliation":[{"name":"Texas Epilepsy Group Dallas Texas U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd","family":"Grinnell","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc. Marlborough Massachusetts U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hailong","family":"Cheng","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc. Marlborough Massachusetts U.S.A"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Blum","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc. 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