{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T20:27:58Z","timestamp":1789244878743,"version":"build-2803163510"},"reference-count":24,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,1,7]],"date-time":"2020-01-07T00:00:00Z","timestamp":1578355200000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003769","name":"Eisai","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003769","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Study 311 (NCT02849626) was a global, multicenter, open\u2010label, single\u2010arm study that assessed safety, tolerability, pharmacokinetics, and pharmacokinetics\/pharmacodynamics of once\u2010daily adjunctive perampanel oral suspension in pediatric patients (aged 4 to &lt;12\u00a0years) with focal seizures (FS) (with\/without focal to bilateral tonic\u2010clonic seizures [FBTCS]) or generalized tonic\u2010clonic seizures (GTCS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In the 311 Core Study, a 4\u2010week Pre\u2010treatment Period (Screening\/Baseline) preceded a 23\u2010week Treatment Period (11\u2010week Titration; 12\u2010week Maintenance) and 4\u2010week Follow\u2010up. Endpoints included safety\/tolerability (primary endpoint), median percent change in seizure frequency per 28\u00a0days from Baseline (Treatment Period), and 50% responder and seizure\u2010freedom rates (Maintenance Period). Patients were stratified by age (4 to &lt;7; 7 to &lt;12\u00a0years) and concomitant enzyme\u2010inducing anti\u2010seizure drug (EIASD) use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One hundred eighty patients were enrolled (FS, n\u00a0=\u00a0149; FBTCS, n\u00a0=\u00a054; GTCS, n\u00a0=\u00a031). The Core Study was completed by 146 patients (81%); the most common primary reason for discontinuation was adverse event (AE) (n\u00a0=\u00a014 [8%]). Mean (standard deviation) daily perampanel dose was 7.0 (2.6) mg\/day and median (interquartile range) duration of exposure was 22.9 (2.0) weeks. The overall incidence of treatment\u2010emergent AEs (TEAEs; 89%) was similar between patients with FS (with\/without FBTCS) and GTCS. The most common TEAEs were somnolence (26%) and nasopharyngitis (19%). There were no clinically important changes observed for cognitive function, laboratory, or electrocardiogram (ECG) parameters or vital signs. Median percent reductions in seizure frequency per 28\u00a0days from Baseline were as follows: 40% (FS), 59% (FBTCS), and 69% (GTCS). Corresponding 50% responder and seizure\u2010freedom rates were as follows: FS, 47% and 12%; FBTCS, 65% and 19%; and GTCS, 64% and 55%, respectively. Improvements in response\/seizure frequency from Baseline were seen regardless of age or concomitant EIASD use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>Results from the 311 Core Study suggest that daily oral doses of adjunctive perampanel are generally safe, well tolerated, and efficacious in children age 4 to &lt;12\u00a0years with FS (with\/without FBTCS) or GTCS.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.16413","type":"journal-article","created":{"date-parts":[[2020,1,8]],"date-time":"2020-01-08T04:59:22Z","timestamp":1578459562000},"page":"125-137","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":60,"title":["Open\u2010label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to &lt;12\u00a0years) with inadequately controlled focal seizures or generalized tonic\u2010clonic seizures"],"prefix":"10.1111","volume":"61","author":[{"given":"Andras","family":"Fogarasi","sequence":"first","affiliation":[{"name":"Epilepsy Center Bethesda Children\u2019s Hospital Budapest Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Flamini","sequence":"additional","affiliation":[{"name":"Pediatric and Adolescent Neurodevelopmental Associates Atlanta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathieu","family":"Milh","sequence":"additional","affiliation":[{"name":"Pediatric Neurology Unit La Timone Enfants Hospital Marseille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Phillips","sequence":"additional","affiliation":[{"name":"Mary Bridge Children\u2019s Neurology Clinic Tacoma WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3996-8671","authenticated-orcid":false,"given":"Shinsaku","family":"Yoshitomi","sequence":"additional","affiliation":[{"name":"NHO Shizuoka Institute of Epilepsy and Neurological Disorders Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Patten","sequence":"additional","affiliation":[{"name":"Eisai Ltd. Hatfield, Hertfordshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takao","family":"Takase","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Laurenza","sequence":"additional","affiliation":[{"name":"Formerly: Eisai Inc. Woodcliff Lake NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leock Y.","family":"Ngo","sequence":"additional","affiliation":[{"name":"Eisai Inc. Woodcliff Lake NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,1,7]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.2147\/JRLCR.S51475"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/17460441.2019.1566318"},{"key":"e_1_2_9_4_1","unstructured":"European Medicines Agency (EMA).Fycompa\u00aeAnnex I: summary of product characteristics. 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Guidance for industry. Available at:https:\/\/www.fda.gov\/media\/110916\/download. 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