{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T14:35:59Z","timestamp":1781706959897,"version":"3.54.5"},"reference-count":35,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2024,10,26]],"date-time":"2024-10-26T00:00:00Z","timestamp":1729900800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011110","name":"UCB","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011110","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>This study was undertaken to assess long\u2010term safety, tolerability, and efficacy of lacosamide (LCM) as adjunctive therapy for generalized onset tonic\u2013clonic seizures (GTCS) in patients aged \u22654\u2009years with idiopathic generalized epilepsy (IGE).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>EP0012 (NCT02408549) was a phase 3, multicenter, open\u2010label extension (OLE) trial. Patients were enrolled from SP0982 (NCT02408523). Trial duration was \u22652\u2009years (adults) and \u22645\u2009years (children). The trial consisted of a treatment period, \u22644\u2010week taper period, and 30\u2010day safety follow\u2010up. Safety (primary) variables were incidence of treatment\u2010emergent adverse events (TEAEs), discontinuations due to TEAEs, incidence of onset of absence or myoclonic seizures, and increase in days with absence or myoclonic seizures per 28\u2009days. Efficacy (secondary) variable was percent change in GTCS frequency per 28\u2009days. Kaplan\u2013Meier estimated retention rates and analyses by number of lifetime antiseizure medications (ASMs) were performed post hoc.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 239 patients (mean age\u2009=\u200927.9\u2009years, 56.1% female, 18.4% children) were enrolled and received \u22651 dose of LCM in this OLE (median treatment duration\u2009=\u20093.2\u2009years); 157 (65.7%) completed the trial, and 82 (34.3%) discontinued. The most common reason for discontinuation (\u226510%) was withdrawn consent (30 [12.6%]). Kaplan\u2013Meier estimated retention rate was 87%, 72%, and 60% at 1, 3, and 5\u2009years, respectively. Overall, 222 (92.9%) patients reported TEAEs; 19 (7.9%) discontinued due to TEAEs. Few patients had an increase in number of days with absence or myoclonic seizures, or incidence of new absence or myoclonic seizures. Median percent change in GTCS frequency per 28\u2009days from the combined baseline was \u221288.6% (range =\u2009\u2212100.0 to 465.4, <jats:italic>n<\/jats:italic>\u2009=\u2009238). Post hoc analyses demonstrated small numerical differences between patients with 1, 2, and \u22653 lifetime ASMs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>The results support the use of long\u2010term adjunctive LCM for GTCS in patients with IGE. Long\u2010term adjunctive LCM was efficacious and well tolerated independent of the number of ASMs used before LCM initiation.<\/jats:p><jats:p>Clinical trial registration: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>: NCT02408549.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.18158","type":"journal-article","created":{"date-parts":[[2024,10,26]],"date-time":"2024-10-26T12:30:18Z","timestamp":1729945818000},"page":"3488-3500","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Long\u2010term safety and efficacy of adjunctive lacosamide in the treatment of generalized onset tonic\u2013clonic seizures: An open\u2010label extension trial"],"prefix":"10.1111","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4823-0537","authenticated-orcid":false,"given":"David G.","family":"Vossler","sequence":"first","affiliation":[{"name":"Department of Neurology University of Washington School of Medicine  Seattle Washington USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6016-2883","authenticated-orcid":false,"given":"Mark Kristof","family":"Farkas","sequence":"additional","affiliation":[{"name":"Pediatric Center Semmelweis University  Budapest Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Poverennova","sequence":"additional","affiliation":[{"name":"Seredavin Regional Clinical Hospital  Samara Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masako","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Shinjuku Neuro Clinic and National Center of Neurology and Psychiatry  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Conrath","sequence":"additional","affiliation":[{"name":"UCB  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7014-0007","authenticated-orcid":false,"given":"Svetlana","family":"Dimova","sequence":"additional","affiliation":[{"name":"UCB  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carrie","family":"McClung","sequence":"additional","affiliation":[{"name":"UCB  Morrisville North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-5402-0808","authenticated-orcid":false,"given":"Robert","family":"Roebling","sequence":"additional","affiliation":[{"name":"UCB  Monheim am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paulette","family":"Williams","sequence":"additional","affiliation":[{"name":"UCB  Morrisville North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7198-8621","authenticated-orcid":false,"given":"Terence J.","family":"O'Brien","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, School of Translational Medicine Monash University and Department of Neurology, Alfred Health  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the EP0012 Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,26]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"World Health Organization (WHO).Epilepsy.2024Retrieved February 23 2024 from:https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/epilepsy"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2017.3949"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.3880"},{"key":"e_1_2_12_5_1","unstructured":"World Health Organization.Epilepsy: a public health imperative.2024Retrieved February 23 2024 from:https:\/\/www.who.int\/publications\/i\/item\/epilepsy\u2010a\u2010public\u2010health\u2010imperative"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.13709"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17236"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17237"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000208076"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.4103\/aian.aian_888_21"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eplepsyres.2014.11.021"},{"key":"e_1_2_12_12_1","unstructured":"UCB Inc.VIMPAT\u00ae (lacosamide) US Prescribing Information. 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