{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T18:02:58Z","timestamp":1775066578809,"version":"3.50.1"},"reference-count":22,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T00:00:00Z","timestamp":1716508800000},"content-version":"vor","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A <jats:italic>post hoc<\/jats:italic> analysis of data from Asian patients included in the study BIA\u20102093\u2010304 was conducted to evaluate the long\u2010term safety\/tolerability and efficacy of adjunctive eslicarbazepine acetate (ESL) in adult Asian patients with refractory focal seizures. Part I was a randomized controlled trial, in which patients received ESL (800 or 1200 mg once daily [QD]) or placebo, assessed over a 12\u2010week maintenance period. Patients completing Part I could enter two open\u2010label extension periods (Part II, 1 year; Part III, \u22652\u2009years), during which all received ESL (400\u20131600 mg QD). Safety\/tolerability was assessed by evaluating treatment\u2010emergent adverse events (TEAEs). Efficacy assessments included responder and seizure freedom rates. The safety population included 125, 92, and 23 Asian patients in Parts I, II, and III, respectively. Incidence of ESL\u2010related TEAEs was 61.3%, 45.7%, and 17.4% during Parts I, II, and III, respectively. ESL\u2010related TEAEs (most commonly, dizziness, somnolence, and headache) were consistent with ESL's known safety profile. During Part I, responder rates were higher with ESL 800 (41.7%) and 1200 mg QD (44.4%) versus placebo (32.6%), although not statistically significant. Seizure freedom rates with ESL 800 (5.5%) and 1200 mg QD (11.1%) were also higher versus placebo (0%) (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05 for ESL 1200 mg QD versus placebo). At the end of Part II, responder and seizure freedom rates were 60.3% and 14.7%, respectively. In summary, adult Asian patients with refractory focal seizures were responsive to treatment with ESL as adjunctive therapy and generally showed treatment tolerance well for up to 3\u2009years. No new\/unexpected safety findings were observed.<\/jats:p>","DOI":"10.1111\/cts.13802","type":"journal-article","created":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T13:50:01Z","timestamp":1716558601000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Long\u2010term effects of adjunctive eslicarbazepine acetate in adult Asian patients with refractory focal seizures: <i>Post hoc<\/i> analysis of a phase III trial"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1908-0699","authenticated-orcid":false,"given":"Sang Kun","family":"Lee","sequence":"first","affiliation":[{"name":"Seoul National University Hospital  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6743-0545","authenticated-orcid":false,"given":"Sang Ahm","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Neurology, Asan Medical Center University of Ulsan College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1684-637X","authenticated-orcid":false,"given":"Seung Bong","family":"Hong","sequence":"additional","affiliation":[{"name":"Samsung Medical Center Sungkyunkwan University School of Medicine and Samsung Advanced Institute for Health Sciences &amp; Technology (SAIHST)  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6127-1045","authenticated-orcid":false,"given":"Yong Won","family":"Cho","sequence":"additional","affiliation":[{"name":"Keimyung University Dongsan Medical Center  Daegu South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guillermo","family":"Castilla\u2010Fern\u00e1ndez","sequence":"additional","affiliation":[{"name":"BIAL R&amp;D Investments, S.A  Porto Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miguel M.","family":"Fonseca","sequence":"additional","affiliation":[{"name":"BIAL R&amp;D Investments, S.A  Porto Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joana","family":"Moreira","sequence":"additional","affiliation":[{"name":"BIAL \u2013 Portela &amp; C\u00aa, S.A  Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helena","family":"Gama","sequence":"additional","affiliation":[{"name":"BIAL \u2013 Portela &amp; C\u00aa, S.A  Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joerg","family":"Holenz","sequence":"additional","affiliation":[{"name":"BIAL \u2013 Portela &amp; C\u00aa, S.A  Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,5,24]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.14458"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.14642"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2008.141"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.14645"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.fpc.0000199500.46842.4a"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740330903427969"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1155\/2018\/2780272"},{"key":"e_1_2_10_9_1","first-page":"448","article-title":"Contributions of CYP2C9\/CYP2C19 genotypes and drug interaction to the phenytoin treatment in the Korean epileptic patients in the clinical setting","volume":"40","author":"Lee SY","year":"2007","journal-title":"J Biochem Mol Biol"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0b013e318030def0"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.5414\/CP203083"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.1998.tb01330.x"},{"key":"e_1_2_10_13_1","unstructured":"European Medicines Agency.Zebinix\u00ae Summary of Product Characteristics.2022Available at:https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/zebinix\u2010epar\u2010product\u2010information_en.pdf"},{"key":"e_1_2_10_14_1","unstructured":"US Food and Drug Administration.Aptiom\u00ae Prescribing Information.2019Available at:https:\/\/www.aptiom.com\/Aptiom\u2010Prescribing\u2010Informationpdf"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2008.01946.x"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eplepsyres.2010.01.014"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0404.2009.01218.x"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12894"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13344"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1177\/2042098613499791"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-018-0111-2"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-013-0077-x"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2017.04.019"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.13802","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,28]],"date-time":"2024-05-28T11:26:31Z","timestamp":1716895591000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.13802"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5]]},"references-count":22,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["10.1111\/cts.13802"],"URL":"https:\/\/doi.org\/10.1111\/cts.13802","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5]]},"assertion":[{"value":"2023-10-31","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-22","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-24","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e13802"}}