{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T13:06:58Z","timestamp":1792242418892,"version":"4.4.0"},"reference-count":34,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,5,21]],"date-time":"2023-05-21T00:00:00Z","timestamp":1684627200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006546","name":"Angelini Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006546","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100015050","name":"Sociedad Espa\u00f1ola de Epilepsia","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100015050","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia Open"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study investigated early, real\u2010world outcomes with cenobamate (CNB) in a large series of patients with highly drug\u2010resistant epilepsy within a Spanish Expanded Access Program (EAP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method<\/jats:title>\n                    <jats:p>This was a multicenter, retrospective, observational study in 14 hospitals. Inclusion criteria were age\u2009\u226518\u2009years, focal seizures, and EAP authorization. Data were sourced from patient clinical records. Primary effectiveness endpoints included reductions (100%, \u226590%, \u226575%, and \u226550%) or worsening in seizure frequency at 3\u2010, 6\u2010, and 12\u2010month visits and at the last visit. Safety endpoints included rates of adverse events (AEs) and AEs leading to discontinuation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The study included 170 patients. At baseline, median epilepsy duration was 26\u2009years and median number of seizures\/month was 11.3. The median number of prior antiseizure medications (ASMs) and concomitant ASMs were 12 and 3, respectively. Mean CNB dosages\/day were 176\u2009mg, 200\u2009mg, and 250\u2009mg at 3, 6, and 12\u2009months. Retention rates were 98.2%, 94.5%, and 87% at 3, 6, and 12\u2009months. At last available visit, the rate of seizure freedom was 13.3%; \u226590%, \u226575%, and\u2009\u226550% responder rates were 27.9%, 45.5%, and 63%, respectively. There was a significant reduction in the number of seizures per month (mean: 44.6%; median: 66.7%) between baseline and the last visit (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001). Responses were maintained regardless of the number of prior or concomitant ASMs. The number of concomitant ASMs was reduced in 44.7% of patients. The cumulative percentage of patients with AEs and AEs leading to discontinuation were 68.2% and 3.5% at 3\u2009months, 74.1% and 4.1% at 6\u2009months, and 74.1% and 4.1% at 12\u2009months. The most frequent AEs were somnolence and dizziness.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Significance<\/jats:title>\n                    <jats:p>In this highly refractory population, CNB showed a high response regardless of prior and concomitant ASMs. AEs were frequent but mostly mild\u2010to\u2010moderate, and few led to discontinuation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/epi4.12757","type":"journal-article","created":{"date-parts":[[2023,5,7]],"date-time":"2023-05-07T12:24:41Z","timestamp":1683462281000},"page":"918-929","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":87,"title":["Real\u2010world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program"],"prefix":"10.1002","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2080-8042","authenticated-orcid":false,"given":"Vicente","family":"Villanueva","sequence":"first","affiliation":[{"name":"Hospital Universitario y Polit\u00e9cnico La Fe, Member of EPICARE  Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Santos\u2010Carrasco","sequence":"additional","affiliation":[{"name":"Centro Neurolog\u00eda Avanzada  Sevilla Spain"},{"name":"Departamento de Psicolog\u00eda Experimental Universidad de Sevilla  Sevilla Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6421-5348","authenticated-orcid":false,"given":"Pablo","family":"Cabezudo\u2010Garc\u00eda","sequence":"additional","affiliation":[{"name":"Hospital Regional Universitario Malaga  Malaga Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asier","family":"G\u00f3mez\u2010Ib\u00e1\u00f1ez","sequence":"additional","affiliation":[{"name":"Clinica Universidad de Navarra  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mercedes","family":"Garc\u00e9s","sequence":"additional","affiliation":[{"name":"Hospital Universitario y Polit\u00e9cnico La Fe, Member of EPICARE  Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3414-2707","authenticated-orcid":false,"given":"Pedro","family":"Serrano\u2010Castro","sequence":"additional","affiliation":[{"name":"Hospital Regional Universitario Malaga  Malaga Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria D.","family":"Castro\u2010Vilanova","sequence":"additional","affiliation":[{"name":"Complejo Hospitalario Universitario Vigo  Vigo Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D\u00e9bora","family":"Sayas","sequence":"additional","affiliation":[{"name":"Hospital Universitario y Polit\u00e9cnico La Fe, Member of EPICARE  Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco J.","family":"Lopez\u2010Gonzalez","sequence":"additional","affiliation":[{"name":"Complejo Hospitalario Universitario Santiago  Santiago de Compostela Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiana","family":"Rodr\u00edguez\u2010Osorio","sequence":"additional","affiliation":[{"name":"Complejo Hospitalario Universitario Santiago  Santiago de Compostela Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustavo","family":"Torres\u2010Gaona","sequence":"additional","affiliation":[{"name":"Clinica Corachan  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosa A.","family":"Saiz\u2010Diaz","sequence":"additional","affiliation":[{"name":"Hospital Universitario  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3582-060X","authenticated-orcid":false,"given":"Kevin G.","family":"Hampel","sequence":"additional","affiliation":[{"name":"Hospital Universitario y Polit\u00e9cnico La Fe, Member of EPICARE  Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meritxell","family":"Martinez\u2010Ferri","sequence":"additional","affiliation":[{"name":"Hospital Universitari Mutua Terrassa  Terrassa Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria J.","family":"Aguilar\u2010Amat","sequence":"additional","affiliation":[{"name":"Instituto de Investigaci\u00f3n Sanitaria del Hospital Universitario La Paz\u2014IdiPAZ  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4374-5574","authenticated-orcid":false,"given":"Blanca","family":"Mercedes\u2010Alvarez","sequence":"additional","affiliation":[{"name":"Hospital Universitario Gregorio Mara\u00f1on  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanessa","family":"Garc\u00eda\u2010Morales","sequence":"additional","affiliation":[{"name":"Hospital Universitario Alava  Alava Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"del Villar\u2010Igea","sequence":"additional","affiliation":[{"name":"Consorcio Hospitalario Provincial de Castellon  Castellon Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9864-8766","authenticated-orcid":false,"given":"Andreu","family":"Massot\u2010Tarr\u00fas","sequence":"additional","affiliation":[{"name":"Hospital Universitari Mutua Terrassa  Terrassa Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan J.","family":"Rodr\u00edguez\u2010Uranga","sequence":"additional","affiliation":[{"name":"Centro Neurolog\u00eda Avanzada  Sevilla Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,5,21]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2017.3949"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2009.02397.x"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000286959.22040.6e"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2021.108222"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/brb3.2589"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.13723"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000010862"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.2174\/1871527321666220113110044"},{"key":"e_1_2_11_10_1","unstructured":"ONTOZRY.Summary of Product Characteristics. Accessed January 2023.https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/ontozry\u2010epar\u2010product\u2010information_en.pdf"},{"key":"e_1_2_11_11_1","unstructured":"XCOPRI Prescribing Information. Accessed January 2023.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/212839s000lbl.pdf"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000009530"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(19)30399-0"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.16525"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000200792"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17007"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1684\/epd.2010.0303"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2008.01618_2.x"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2016.10.025"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.seizure.2022.10.004"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17427"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2022.950171"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2022.108679"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pediatrneurol.2022.01.001"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebr.2022.100533"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17549"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17091"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17134"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1080\/14737175.2023.2171291"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eplepsyres.2021.106592"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17092"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-022-00400-5"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.seizure.2022.02.003"},{"key":"e_1_2_11_34_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17515"},{"key":"e_1_2_11_35_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.17564"}],"container-title":["Epilepsia Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/epi4.12757","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T05:48:39Z","timestamp":1693547319000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/epi4.12757"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,5,21]]},"references-count":34,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023,9]]}},"alternative-id":["10.1002\/epi4.12757"],"URL":"https:\/\/doi.org\/10.1002\/epi4.12757","archive":["Portico"],"relation":{},"ISSN":["2470-9239","2470-9239"],"issn-type":[{"value":"2470-9239","type":"print"},{"value":"2470-9239","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,5,21]]},"assertion":[{"value":"2023-03-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-05-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-05-21","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}