{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T14:12:03Z","timestamp":1780495923403,"version":"3.54.1"},"reference-count":19,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2019,12,26]],"date-time":"2019-12-26T00:00:00Z","timestamp":1577318400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"BIAL \u2013 Portela & C"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Child Neurol"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To evaluate the safety and tolerability of adjunctive eslicarbazepine acetate (ESL) in pediatric patients (aged 4-17 years) with refractory focal seizures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Pooled safety data from patients aged 4-17 years in Study 208 (NCT01527513) and Study 305 (NCT00988156) were analyzed. Both were randomized, double-blind, placebo-controlled studies of ESL as adjunctive treatment in pediatric patients with refractory focal seizures receiving 1 or 2 antiepileptic drugs. Incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to discontinuation, and TEAEs of special interest were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The safety population comprised 362 patients (placebo, n = 160; ESL, n = 202). The overall incidence of TEAEs was similar between the ESL (67.8%) and placebo groups (65.6%), with no clear dose-response relationship. The most frequently reported TEAEs with ESL were headache, somnolence, vomiting, and diplopia. Overall incidences of SAEs and TEAEs leading to discontinuation were higher with ESL versus placebo (9.9% vs 5.0% and 5.9% vs 2.5%, respectively). The majority of SAEs with ESL occurred in Study 305. Two deaths were reported, 1 with ESL (0.5%) due to cluster seizures (resulting in herniation of the cerebellar tonsils) and 1 with placebo (0.6%) due to asphyxia. TEAEs related to allergic reaction, hyponatremia, hypothyroidism, cytopenia, seizure exacerbation, cognitive dysfunction, psychiatric disorders, or suicide occurred infrequently (&lt;9%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Adjunctive ESL was generally well tolerated in children aged 4-17 years with focal seizures. The safety profile of ESL in children was comparable to that observed in adults.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0883073819890997","type":"journal-article","created":{"date-parts":[[2019,12,26]],"date-time":"2019-12-26T23:28:40Z","timestamp":1577402920000},"page":"265-273","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures"],"prefix":"10.1177","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1738-9644","authenticated-orcid":false,"given":"Mark","family":"Mintz","sequence":"first","affiliation":[{"name":"The Center for Neurological and Neurodevelopmental Health (CNNH) and the Clinical Research Center of New Jersey (CRCNJ), Voorhees, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jesus E.","family":"Pina-Garza","sequence":"additional","affiliation":[{"name":"Centennial Children\u2019s Hospital, Nashville, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven M.","family":"Wolf","sequence":"additional","affiliation":[{"name":"Department of Neurology, Icahn School of Medicine, Mount Sinai Health System, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia E.","family":"McGoldrick","sequence":"additional","affiliation":[{"name":"Department of Neurology, Icahn School of Medicine, Mount Sinai Health System, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergiusz","family":"J\u00f3zwiak","sequence":"additional","affiliation":[{"name":"Department of Pediatric Neurology, Medical University Warsaw, Warsaw, Poland"},{"name":"Department of Neurology and Epileptology, The Children\u2019s Memorial Health Institute, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd","family":"Grinnell","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc, Marlborough, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Cantu","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc, Marlborough, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raquel","family":"Costa","sequence":"additional","affiliation":[{"name":"BIAL\u2013Portela & C\u00aa, SA, Coronado (S\u00e3o Rom\u00e3o e S\u00e3o Mamede), Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joana","family":"Moreira","sequence":"additional","affiliation":[{"name":"BIAL\u2013Portela & C\u00aa, SA, Coronado (S\u00e3o Rom\u00e3o e S\u00e3o Mamede), Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Li","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc, Marlborough, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Blum","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc, Marlborough, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2019,12,26]]},"reference":[{"key":"bibr1-0883073819890997","doi-asserted-by":"publisher","DOI":"10.1684\/epd.2015.0736"},{"key":"bibr2-0883073819890997","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2017.04.019"},{"key":"bibr3-0883073819890997","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000002497"},{"key":"bibr4-0883073819890997","unstructured":"Department of Health and Human Services Food and Drug Administration. Best Pharmaceuticals for Children Act and Pediatric Research Equity Act. July 2016 status report to Congress. https:\/\/www.fda.gov\/ScienceResearch\/SpecialTopics\/PediatricTherapeuticsResearch\/ucm509707.htm. Published 2016. Accessed August 2017."},{"key":"bibr5-0883073819890997","unstructured":"Food and Drug Administration. Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 4 years of age and older. Guidance for Industry. Draft Guidance. https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM596731.pdf. Published 2018. Accessed October 2018."},{"key":"bibr6-0883073819890997","unstructured":"Mehrotra S. Quantitative analysis to support full extrapolation of efficacy in children for partial onset seizures in adjunctive setting: FDA-PEACE initiative. http:\/\/pharmacy.umaryland.edu\/media\/SOP\/wwwpharmacyumarylandedu\/centers\/cersievents\/pedsextrapolation\/mehrotra-presentation-notes.pdf. Published 2016. Accessed May 2017."},{"key":"bibr7-0883073819890997","unstructured":"Men AY. Assessing quality and quantity of data to establish exposure-response similarity between adults and pediatric patients: PEACE initiative. https:\/\/www.pharmacy.umaryland.edu\/media\/SOP\/wwwpharmacyumarylandedu\/centers\/cersievents\/pediatricpbpk\/Men%20-%20PEACE%20Initiative.pdf. Published 2015. Accessed May 2017."},{"key":"bibr8-0883073819890997","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e31826d5ec0"},{"key":"bibr9-0883073819890997","unstructured":"HHS, FDA, CDER, and CBER (2003) Guidance for Industry. Exposure-response relationships \u2014 study design, data analysis, and regulatory applications. https:\/\/www.fda.gov\/downloads\/drugs\/guidancecomplianceregulatoryinformation\/guidances\/ucm072109.pdf. Accessed January 29, 2018."},{"key":"bibr10-0883073819890997","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2010-3487"},{"key":"bibr11-0883073819890997","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.744"},{"key":"bibr12-0883073819890997","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2018.01.029"},{"key":"bibr13-0883073819890997","volume-title":"Presented at the World Congress of Neurology","author":"Rocha J"},{"key":"bibr14-0883073819890997","doi-asserted-by":"publisher","DOI":"10.1111\/epi.13946"},{"key":"bibr15-0883073819890997","doi-asserted-by":"publisher","DOI":"10.1046\/j.1528-1157.43.s.3.5.x"},{"key":"bibr16-0883073819890997","unstructured":"Deb S. The use of medication for the management of problem (challenging) behaviour in adults who have intellectual disabilities. http:\/\/www.intellectualdisability.info\/mental-health\/articles\/the-use-of-medications-for-the-management-of-problem-behaviours-in-adults-who-have-intellectual-disabilities. Published 2018. Accessed September 2018."},{"key":"bibr17-0883073819890997","unstructured":"AAP News (2016) Food and Drug Administration update, 6 April 2016. http:\/\/www.aappublications.org\/news\/2016\/04\/06\/FDAUpdate040616. Accessed August 25, 2017."},{"key":"bibr18-0883073819890997","unstructured":"Sunovion Pharmaceuticals Inc. Aptiom\u00ae (eslicarbazepine acetate), full prescribing information, 2019. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022416s011lbl.pdf. 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