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Retention and effectiveness were assessed after 3, 6, and 12\u00a0months, and at the last visit (last observation carried forward). Effectiveness assessments included 50% responder rate (\u2265\u200950% reduction in seizure frequency from baseline) and seizure freedom rate (no seizures since at least the prior visit); in PWE with status epilepticus, response was defined as seizures under control. Safety and tolerability were assessed by evaluating adverse events (AEs) and discontinuation due to AEs. The Full Analysis Set included 5193 PWE. Retention, effectiveness and safety\/tolerability were assessed in 4721, 4392 and 4617, respectively. Retention on PER treatment at 3, 6, and 12\u00a0months was 90.5%, 79.8%, and 64.2%, respectively. Mean retention time on PER treatment was 10.8\u00a0months. The 50% responder rate was 58.3% at 12\u00a0months and 50.0% at the last visit, and the corresponding seizure freedom rates were 23.2% and 20.5%, respectively; 52.7% of PWE with status epilepticus responded to PER treatment. Overall, 49.9% of PWE reported AEs and the most frequently reported AEs (\u2265\u20095% of PWE) were dizziness\/vertigo (15.2%), somnolence (10.6%), irritability (8.4%), and behavioral disorders (5.4%). At 12\u00a0months, 17.6% of PWEs had discontinued due to AEs. PERMIT demonstrated that PER is effective and generally well tolerated when used to treat people with focal and\/or generalized epilepsy in everyday clinical practice.<\/jats:p>","DOI":"10.1007\/s00415-021-10751-y","type":"journal-article","created":{"date-parts":[[2021,8,24]],"date-time":"2021-08-24T11:03:41Z","timestamp":1629803021000},"page":"1957-1977","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":62,"title":["PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice"],"prefix":"10.1007","volume":"269","author":[{"given":"Vicente","family":"Villanueva","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1750-5131","authenticated-orcid":false,"given":"Wendyl","family":"D\u2019Souza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroko","family":"Goji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong Wook","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2845-1332","authenticated-orcid":false,"given":"Claudio","family":"Liguori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rob","family":"McMurray","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Imad","family":"Najm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1915-0335","authenticated-orcid":false,"given":"Estevo","family":"Santamarina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernhard J.","family":"Steinhoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8321-5864","authenticated-orcid":false,"given":"Pavel","family":"Vlasov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tony","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5950-2692","authenticated-orcid":false,"given":"Eugen","family":"Trinka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the PERMIT pooled analysis participants","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,8,24]]},"reference":[{"issue":"7","key":"10751_CR1","doi-asserted-by":"publisher","first-page":"1331","DOI":"10.1111\/j.1528-1167.2011.03109.x","volume":"52","author":"T Hanada","year":"2011","unstructured":"Hanada T, Hashizume Y, Tokuhara N, Takenaka O, Kohmura N, Ogasawara A, Hatakeyama S, Ohgoh M, Ueno M, Nishizawa Y (2011) Perampanel: a novel, orally active, noncompetitive AMPA-receptor antagonist that reduces seizure activity in rodent models of epilepsy. 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Wendyl D\u2019Souza\u2019s salary is part-funded by The University of Melbourne. He has received travel, investigator-initiated, scientific advisory board and speaker honoraria from UCB Pharma Australia & Global; investigator-initiated, scientific advisory board, travel and speaker honoraria from Eisai Australia & Global; advisory board honoraria from Liva Nova and Tilray; educational grants from Novartis Pharmaceuticals, Pfizer Pharmaceuticals and Sanofi-Synthelabo; educational, travel and fellowship grants from GSK Neurology Australia; and honoraria from SciGen Pharmaceuticals. He has an equity interest in the device company EpiMinder and health software company KeyLead Health. Hiroko Goji has no conflicts of interest. Dong Wook Kim has no conflicts of interest. Claudio Liguori has no conflicts of interest. Rob McMurray is an employee of Eisai Europe Ltd. Imad Najm has received honoraria from Eisai. Estevo Santamarina has received honoraria and\/or research funds from Bial, Eisai, Esteve, GW Pharma and UCB Pharma. Bernhard J. Steinhoff has received consultation fees and\/or honoraria from Arvelle, B. Braun Melsungen, Desitin, Eisai, GW Pharma, Neuraxpharm, Precisis, UCB Pharma, and Zogenix. Pavel Vlasov has received consultation fees and\/or honoraria from Alkaloid, Eisai, Novartis, Sanofi, Teva and UCB Pharma. Tony Wu has no conflicts of interest. Eugen Trinka has received consultation fees and\/or speakers honoraria from Angelini, Argenx, Arvelle, Bial, Biogen-Idec, Boehringer Ingelheim, Eisai, Epilog, EVER Pharma, Genzyme, GL Pharma, GW Pharmaceuticals, Hikma, LivaNova, Marinus, Medtronic, NewBridge, Novartis, Sanofi, and UCB Pharma.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"All human studies outlined in this article were approved by the appropriate ethics committees and have, therefore, been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All persons gave their informed consent prior to their inclusion in the studies, according to the protocol.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}