{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T23:20:29Z","timestamp":1781824829549,"version":"3.54.5"},"reference-count":18,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,5,6]],"date-time":"2022-05-06T00:00:00Z","timestamp":1651795200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004896","name":"Eisai Incorporated","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004896","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia Open"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Assess the longer\u2010term efficacy and safety of adjunctive perampanel (up to 12\u2009mg\/day) in patients aged \u226512\u2009years with generalized tonic\u2013clonic (GTC) seizures from the Open\u2010label Extension (OLEx) Phase of Study 332 to determine whether responses obtained during the Core Study are maintained during long\u2010term treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with GTC seizures previously enrolled in a randomized placebo\u2010controlled trial of perampanel could enter an OLEx Phase comprising 6\u2010week blinded conversion (during which patients previously randomized to placebo\u2010switched to perampanel) and up to 136\u2010week maintenance periods (maximum perampanel dose of 12\u2009mg\/day). A 4\u2010week follow\u2010up period was completed by all patients after the last on\u2010treatment visit during the OLEx. We assessed seizure frequency outcomes from preperampanel baseline and the Core Study Pre\u2010randomization Phase, retention rates, doses selected, and treatment\u2010emergent adverse events (TEAEs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 138 patients entered the OLEx. Median percent reductions in GTC seizures per 28\u2009days from preperampanel were 77% (Weeks 1\u201013) and 90% (Weeks 40\u201052). Retention rates were 88% (6\u2009months) and 75% (12\u00a0months). Seizure\u2010freedom rates were maintained for at least 2\u2009years regardless of prior treatment received during the Core Study. Most common modal daily dose was &gt;4\u20108\u00a0mg\/day (n\u00a0=\u00a093). Across the Core and OLEx Phases, 120 (87%) patients experienced TEAEs; the most common was dizziness.<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>Perampanel was generally well\u2010tolerated, and the TEAEs reported here are consistent with the known safety profile of perampanel. Perampanel offers a long\u2010term treatment option for patients (aged \u226512\u2009years) with GTC seizures.<\/jats:p><\/jats:sec>","DOI":"10.1002\/epi4.12602","type":"journal-article","created":{"date-parts":[[2022,4,21]],"date-time":"2022-04-21T03:50:13Z","timestamp":1650513013000},"page":"393-405","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Long\u2010term open\u2010label perampanel: Generalized tonic\u2013clonic seizures in idiopathic generalized epilepsy"],"prefix":"10.1002","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2242-8027","authenticated-orcid":false,"given":"Jacqueline A.","family":"French","sequence":"first","affiliation":[{"name":"NYU Grossman School of Medicine  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert T.","family":"Wechsler","sequence":"additional","affiliation":[{"name":"Idaho Comprehensive Epilepsy Center  Boise Idaho USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5950-2692","authenticated-orcid":false,"given":"Eugen","family":"Trinka","sequence":"additional","affiliation":[{"name":"Department of Neurology, Member of the European Reference Network EpiCare, Centre for Cognitive Neuroscience Christian Doppler University Hospital Pracelsus Medical University  Salzburg Austria"},{"name":"Neuroscience Institute, Christian Doppler Medical Centre Paracelsus Medical University and Centre for Cognitive Neuroscience  Salzburg Austria"},{"name":"Karl Landsteiner Institute for Neurorehabilitation and Space Neurology  Salzburg Austria"},{"name":"Department of Public Health UMIT\u2010University for Health Sciences, Medical Informatics and Technology  Hall in Tirol Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8666-1640","authenticated-orcid":false,"given":"Christian","family":"Brandt","sequence":"additional","affiliation":[{"name":"Bethel Epilepsy Center University Hospital for Epileptology  Bielefeld Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terence J.","family":"O'Brien","sequence":"additional","affiliation":[{"name":"The Royal Melbourne Hospital The University of Melbourne  Parkville Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Patten","sequence":"additional","affiliation":[{"name":"Eisai Europe Ltd.  Hertfordshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandro","family":"Salah","sequence":"additional","affiliation":[{"name":"Formerly: Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manoj","family":"Malhotra","sequence":"additional","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,5,6]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001930"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2018.01.039"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2014.915029"},{"key":"e_1_2_11_5_1","unstructured":"Food and Drug Administration (FDA).Fycompa\u00ae prescribing information September 2020. 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