{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T10:48:03Z","timestamp":1778323683486,"version":"3.51.4"},"reference-count":15,"publisher":"Wiley","issue":"s6","license":[{"start":{"date-parts":[[2013,9,3]],"date-time":"2013-09-03T00:00:00Z","timestamp":1378166400000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2013,9]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Benzodiazepine\u2010refractory status epilepticus (established status epilepticus, ESE) is a relatively common emergency condition with several widely used treatments. There are no controlled, randomized, blinded clinical trials to compare the efficacy and tolerability of currently available treatments for ESE. The ESE treatment trial is designed to determine the most effective and\/or the least effective treatment of ESE among patients older than 2\u00a0years by comparing three arms: fosphenytoin (<jats:styled-content style=\"fixed-case\">fPHT<\/jats:styled-content>) levetiracetam (LVT), and valproic acid (VPA). This is a multicenter, randomized, double\u2010blind, Bayesian adaptive, phase III comparative effectiveness trial. Up to 795 patients will be randomized initially 1:1:1, and response\u2010adaptive randomization will occur after 300 patients have been recruited. Randomization will be stratified by three age groups, 2\u201318, 19\u201365, and 66 and older. The primary outcome measure is cessation of clinical seizure activity and improving mental status, without serious adverse effects or further intervention at 60\u00a0min after administration of study drug. Each subject will be followed until discharge or 30\u00a0days from enrollment. This trial will include interim analyses for early success and futility. This trial will be considered a success if the probability that a treatment is the most effective is &gt;0.975 or the probability that a treatment is the least effective is &gt;0.975 for any treatment. Proposed total sample size is 795, which provides 90% power to identify the most effective and\/or the least effective treatment when one treatment arm has a true response rate of 65% and the true response rate is 50% in the other two arms.<\/jats:p>","DOI":"10.1111\/epi.12288","type":"journal-article","created":{"date-parts":[[2013,9,3]],"date-time":"2013-09-03T16:37:20Z","timestamp":1378226240000},"page":"89-92","source":"Crossref","is-referenced-by-count":86,"title":["The Established Status Epilepticus Trial 2013"],"prefix":"10.1111","volume":"54","author":[{"given":"Thomas","family":"Bleck","sequence":"first","affiliation":[{"name":"Department of Neurological Sciences Rush University Medical Center Chicago Illinois U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hannah","family":"Cock","sequence":"additional","affiliation":[{"name":"Department of Clinical Neurology St. George\u2032s University London United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Chamberlain","sequence":"additional","affiliation":[{"name":"School of Medicine and Health Sciences George Washington University Washington District of Columbia U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Cloyd","sequence":"additional","affiliation":[{"name":"Center for Orphan Drug Research University of Minnesota Minneapolis Minnesota U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Connor","sequence":"additional","affiliation":[{"name":"Berry Consulting Group University of Central Florida College of Medicine Orlando Florida U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jordan","family":"Elm","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences Medical University of South Carolina Charleston South Carolina U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nathan","family":"Fountain","sequence":"additional","affiliation":[{"name":"Dreifuss Comprehensive Epilepsy Program University of Virginia Charlottesville Virginia U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Jones","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine University of Texas Houston Texas U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Lowenstein","sequence":"additional","affiliation":[{"name":"Department of Neurology University of California San Francisco San Francisco California U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shlomo","family":"Shinnar","sequence":"additional","affiliation":[{"name":"Montefiore Medical Center Albert Eintein School of Medicine Bronx New York U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Silbergleit","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine University of Michigan Ann Arbor Michigan U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Treiman","sequence":"additional","affiliation":[{"name":"Barrow Neurological Institute St. Joseph's Hospital &amp; 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