{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T20:28:01Z","timestamp":1789244881180,"version":"build-2803163510"},"reference-count":26,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2016,5,25]],"date-time":"2016-05-25T00:00:00Z","timestamp":1464134400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006093","name":"Patient-Centered Outcomes Research Institute","doi-asserted-by":"publisher","award":["PCORI 527"],"award-info":[{"award-number":["PCORI 527"]}],"id":[{"id":"10.13039\/100006093","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2016,7]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>The noncompetitive \u03b1\u2010amino\u20103\u2010hydroxy\u20105\u2010methyl\u20104\u2010isoxazolepropionic acid (<jats:styled-content style=\"fixed-case\">AMPA<\/jats:styled-content>) receptor antagonist perampanel was shown in phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> trials to be an effective and well\u2010tolerated adjunctive treatment for partial\u2010onset seizures. In adolescents, it is necessary to characterize cognitive, neuropsychological, and behavioral side effects of antiepileptic drugs (<jats:styled-content style=\"fixed-case\">AED<\/jats:styled-content>s). The current analysis focuses on behavioral outcomes, efficacy, and safety of perampanel in adolescents.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adolescents (12\u201317 years) on a stable regimen of 1\u20133 <jats:styled-content style=\"fixed-case\">AED<\/jats:styled-content>s for partial\u2010onset seizures were randomized (2:1 ratio) to receive up to 12 mg\/day perampanel or placebo. Alongside efficacy, cognitive, and neuropsychological assessments, behavioral outcomes were measured with the Child Behavior Checklist (<jats:styled-content style=\"fixed-case\">CBCL<\/jats:styled-content>) before and after a 19\u2010week titration and maintenance phase.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the randomized patients, 85 received perampanel and 48 received placebo. Median reduction in seizure frequency from baseline was 58.0% for perampanel and 24.0% for placebo (p = 0.079). More patients had seizure frequency reduced by 50% after perampanel (n = 49 [59.0%]) than placebo (n = 17 [37.0%]; p = 0.0144). Changes in behavior were minimal, and there were no differences between groups on competency (p = 0.619) or problems (p = 0.174). A greater proportion of placebo patients were classified in the <jats:styled-content style=\"fixed-case\">CBCL<\/jats:styled-content> \u201cclinical\u201d range for competency at end of treatment, whereas the number in the perampanel group remained unchanged. The overall safety profile was similar to that reported previously for perampanel; most frequently reported adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) were dizziness (26 patients [30.6% vs. 14.6% placebo]), somnolence (13 patients [15.3% vs. 4.2%]), and headache (nine patients [10.6% vs. 14.6%]). Aggression was reported in seven patients receiving perampanel (8.2% vs. 2.1% placebo); two of these were serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s, with neither requiring treatment discontinuation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>Adjunctive perampanel is efficacious and well tolerated in adolescents with partial\u2010onset seizures, and appears to have no clinically important impact on behavior measured using the <jats:styled-content style=\"fixed-case\">CBCL<\/jats:styled-content>.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.13417","type":"journal-article","created":{"date-parts":[[2016,5,25]],"date-time":"2016-05-25T11:05:04Z","timestamp":1464174304000},"page":"1120-1129","source":"Crossref","is-referenced-by-count":63,"title":["Adjunctive perampanel in adolescents with inadequately controlled partial\u2010onset seizures: A randomized study evaluating behavior, efficacy, and safety"],"prefix":"10.1111","volume":"57","author":[{"given":"Lieven","family":"Lagae","sequence":"first","affiliation":[{"name":"Department of Pediatric Neurology University Hospitals KU Leuven Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicente","family":"Villanueva","sequence":"additional","affiliation":[{"name":"University Hospital and Polytechnic La Fe Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimford J.","family":"Meador","sequence":"additional","affiliation":[{"name":"Department of Neurology &amp; Neurological Sciences Stanford Comprehensive Epilepsy Center Stanford University School of Medicine Stanford California U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makarand","family":"Bagul","sequence":"additional","affiliation":[{"name":"Eisai Ltd Hatfield Hertfordshire United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Laurenza","sequence":"additional","affiliation":[{"name":"Eisai Neuroscience and General Medicine Product Creation Unit Eisai Inc. Woodcliff Lake New Jersey U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dinesh","family":"Kumar","sequence":"additional","affiliation":[{"name":"Eisai Neuroscience and General Medicine Product Creation Unit Eisai Inc. Woodcliff Lake New Jersey U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haichen","family":"Yang","sequence":"additional","affiliation":[{"name":"Eisai Neuroscience and General Medicine Product Creation Unit Eisai Inc. 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