{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:40:28Z","timestamp":1786977628928,"version":"build-2736575974"},"reference-count":27,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,11,15]],"date-time":"2025-11-15T00:00:00Z","timestamp":1763164800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,11,15]],"date-time":"2025-11-15T00:00:00Z","timestamp":1763164800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia Open"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Early response to anti\u2010seizure medication (ASM) is associated with a favorable prognosis in patients with epilepsy. Research is required to confirm existing data on the clinical use of perampanel as first adjunctive therapy in different patient groups and different regions. Here, we present a post hoc analysis of four post\u2010marketing studies to examine side by side the efficacy and safety of perampanel administered as the first adjunctive ASM across different geographic settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data from patients receiving first adjunctive perampanel were included in this post hoc analysis from Study 412 (NCT02726074, South Korea), Study 410 (NCT03288129, US), Study 509 (NCT04202159, Germany), and Study 501 (NCT04257604, Italy). Assessments included the median percent reduction from baseline\/screening in seizure frequency, seizure\u2010freedom rate, retention rate, and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 170 patients who received first adjunctive perampanel were included in this study, including 102 patients from Study 412, 44 from Study 410, 13 from Study 509, and 11 from Study 501. At the latest time point in each study, 50% responder rates were \u226562.5% (range, 62.5%\u2013100.0%) across seizure types, while seizure\u2010freedom rates ranged from 25.0% to 100.0% (median, 51.6%). Retention rates were \u226561.8% at Month 6 in all studies and \u226554.5% at Month 12 in Studies 410 and 501 where these data were available. Overall, 46.2%\u201390.9% of patients experienced \u22651 treatment\u2010emergent adverse event (TEAE) and 13.7%\u201327.3% discontinued perampanel due to TEAE(s). The most common TEAEs reported across each study were dizziness (\u226450.0%), somnolence (\u226436.4%), and fatigue (\u226413.6%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Significance<\/jats:title>\n                    <jats:p>The results from this post hoc analysis demonstrated that perampanel as first adjunctive therapy had a good treatment response with no new safety signals observed. Limitations included the post hoc nature of the analysis and the inability to pool data due to study design differences. Overall, these data support the use of perampanel as an early\u2010line treatment in patients with epilepsy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Plain Language Summary<\/jats:title>\n                    <jats:p>This analysis looked at a medicine called perampanel and how well it works for people with epilepsy when it was one of the first medicines added to their regular seizure treatment. Data were collected from four separate studies that were done in South Korea, the United States, Germany, and Italy. Most patients had fewer seizures across all four studies after 6\u2009months of treatment. The most common side effects reported in patients included dizziness and sleepiness. Perampanel worked well when used early during treatment, and most people were able to keep taking perampanel without significant difficulties.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/epi4.70183","type":"journal-article","created":{"date-parts":[[2025,11,15]],"date-time":"2025-11-15T12:20:43Z","timestamp":1763209243000},"page":"101-111","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and safety of perampanel as first adjunctive therapy in patients with focal\u2010onset seizures or generalized tonic\u2010clonic seizures in four post\u2010marketing studies across regions"],"prefix":"10.1002","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0334-539X","authenticated-orcid":false,"given":"Stefano","family":"Meletti","sequence":"first","affiliation":[{"name":"Neurophysiology Department and Epilepsy Center, AOU  Modena Italy"},{"name":"University of Modena and Reggio Emilia  Modena Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0552-6736","authenticated-orcid":false,"given":"Vineet","family":"Punia","sequence":"additional","affiliation":[{"name":"Epilepsy Center, Cleveland Clinic  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amitabh","family":"Dash","sequence":"additional","affiliation":[{"name":"Eisai Singapore Pte. Ltd.  Singapore Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9106-7922","authenticated-orcid":false,"given":"Anna Lisa","family":"Gentile","sequence":"additional","affiliation":[{"name":"Eisai S.r.l.  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0980-5748","authenticated-orcid":false,"given":"Ricardo","family":"S\u00e1inz\u2010Fuertes","sequence":"additional","affiliation":[{"name":"Eisai Europe, Ltd.  Hatfield Hertfordshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha","family":"Goldman","sequence":"additional","affiliation":[{"name":"Eisai Europe, Ltd.  Hatfield Hertfordshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9754-9144","authenticated-orcid":false,"given":"Tobias","family":"Goldmann","sequence":"additional","affiliation":[{"name":"Eisai GmbH  Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1319-8680","authenticated-orcid":false,"given":"Anna","family":"Patten","sequence":"additional","affiliation":[{"name":"Eisai Europe, Ltd.  Hatfield Hertfordshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dinesh","family":"Kumar","sequence":"additional","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8184-1367","authenticated-orcid":false,"given":"Leock Y.","family":"Ngo","sequence":"additional","affiliation":[{"name":"Eisai Inc.  Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5995-5862","authenticated-orcid":false,"given":"Bernhard J.","family":"Steinhoff","sequence":"additional","affiliation":[{"name":"Kork Epilepsy Center  Kehl\u2010Kork Germany"},{"name":"Clinic for Neurology and Neurophysiology University of Freiburg  Freiburg im Breisgau Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,11,15]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200002033420503"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182563b19"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/2050312118772471"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2017.3949"},{"key":"e_1_2_13_6_1","unstructured":"Food and Drug Administration (FDA).FYCOMPA\u00ae Prescribing 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Abril\u2010JaramilloJ Rodriguez\u2010OsorioX YamamotoT McMurrayR TrinkaE et\u00a0al.Perampanel as early add\u2010on therapy for epilepsy patients with focal\u2010onset and generalized\u2010onset seizures treated in clinical practice. 75th annual meeting of the American Epilepsy Society Chicago IL USA. 3.213 ed2021."},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eplepsyres.2014.03.015"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.8009"}],"container-title":["Epilepsia 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