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The working group discussed nomenclature for antiepileptogenic therapies, subdividing them into \u201cantiepileptogenic therapies\u201d and \u201cdisease modifying therapies,\u201d both of which are urgently needed. We use the example of traumatic brain injury to explain issues and complexities in designing a trial for disease\u2010preventing antiepileptogenic therapies, including identifying timing of intervention, selecting the appropriate dose, and the need for biomarkers. We discuss the recent trials of vigabatrin to prevent onset and modify epilepsy outcome in children with tuberous sclerosis (Epistop and PreVeNT). We describe a potential approach to a disease modification trial in adults, using patients with temporal lobe epilepsy. Finally, we discuss regulatory hurdles for antiepileptogenesis and disease\u2010modifying trials.<\/jats:p>","DOI":"10.1002\/epi4.12526","type":"journal-article","created":{"date-parts":[[2021,7,16]],"date-time":"2021-07-16T19:00:26Z","timestamp":1626462026000},"page":"483-492","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["Antiepileptogenesis and disease modification: Clinical and regulatory issues"],"prefix":"10.1002","volume":"6","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 and NYU Langone Health New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1264-3428","authenticated-orcid":false,"given":"Martina","family":"Bebin","sequence":"additional","affiliation":[{"name":"UAB School of Medicine and UAB Epilepsy Center Birmingham AL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc A.","family":"Dichter","sequence":"additional","affiliation":[{"name":"University of Pennsylvania Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Jerome","family":"Engel","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA and the Brain Research Institute Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5672-3409","authenticated-orcid":false,"given":"Adam L.","family":"Hartman","sequence":"additional","affiliation":[{"name":"Division of Clinical Research National Institute of Neurological Disorders and Stroke\/NIH Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergiusz","family":"J\u00f3\u017awiak","sequence":"additional","affiliation":[{"name":"Department of Child Neurology Medical University of Warsaw Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7244-3722","authenticated-orcid":false,"given":"Pavel","family":"Klein","sequence":"additional","affiliation":[{"name":"Mid\u2010Atlantic Epilepsy and Sleep Center Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0995-6151","authenticated-orcid":false,"suffix":"Sr.","given":"James","family":"McNamara","sequence":"additional","affiliation":[{"name":"Department of Neurobiology Duke University School of Medicine Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4208-6645","authenticated-orcid":false,"given":"Roy","family":"Twyman","sequence":"additional","affiliation":[{"name":"Amron Neuroscience, LLC Darby, MT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Vespa","sequence":"additional","affiliation":[{"name":"Departments of Neurology and Neurosurgery David Geffen School of Medicine UCLA Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,7,29]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"GhaiyoumiA.Epilepsy [Internet].2019. 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