Established Status Epilepticus Treatment Trial (ESETT) - SDMC

苯二氮卓难治性癫痫持续状态（已确立癫痫持续状态，ESE）是一种 相对常见的紧急情况，有几种广泛使用的治疗方法。没有 对照、随机、盲法临床试验，以比较目前 可用的ESE治疗方法。此统计和数据管理中心（SDMC）应用程序 与题为“癫痫持续状态治疗试验”的提案有关。 来自弗吉尼亚大学（Jaideep Kapur，联系PI）。这些应用共同描述了 ESE治疗试验（ESETT），旨在确定最有效的和/或 通过比较以下三组，确定2岁以上患者的ESE治疗效果最差： 磷苯妥英（FOS）、左乙拉西坦（LEV）和丙戊酸（VPA）。这是一个多中心， 随机、双盲、贝叶斯自适应、III期比较有效性试验。高达 795例患者最初将以1：1：1的比例随机化，并将进行缓解适应性随机化 招募了300名患者后。随机化将按3个年龄组分层，2- 18、19-65和66岁及以上。主要结局指标是临床停止 癫痫活动和精神状态改善，无严重不良反应或进一步 研究药物给药后60分钟进行干预。将对每例受试者进行随访，直至 出院或入组后30天。本试验将包括早期成功的中期分析 和徒劳如果治疗的可能性最大，则该试验将被视为成功 有效的概率大于0.975或治疗效果最差的概率大于0.975 0.975以上的治疗。这将是ESE在儿童中的第一个III期临床试验， 成年人了

Benzodiazepine-refractory 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 of ESE. This Statistical and Data Management Center (SDMC) application is linked with the proposal entitled "Established Status Epilepticus Treatment Trial (ESETT)" from the University of Virginia (Jaideep Kapur, contact PI). These applications jointly describe the ESE treatment trial (ESETT), which is designed to determine the most effective and/or the least effective treatment of ESE among patients older than two years by comparing three arms: fosphenytoin (FOS), levetiracetam (LEV), and valproic acid (VPA). This is a multicenter, randomized, double-blind, Bayesian adaptive, Phase III comparative effectiveness trial. Up to 795 patients will be randomized initially 1:1:1 and response-adaptive randomization will occur after 300 patients have been recruited. Randomization will be stratified by three age groups, 2- 18, 19-65, and 66 years 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 min after administration of study drug. Each subject will be followed until discharge or 30 days 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 greater than 0.975 or the probability that a treatment is the least effective is greater than 0.975 for any treatment. This will be the first phase III clinical trial of ESE in children and adults.