Established Status Epilepticus Treatment Trial (ESETT) - SDMC

苯二氮卓类难治性癫痫持续状态(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，比较目前 ESE的现有治疗方法。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(ESETT)”的提案相联系。 来自弗吉尼亚大学(JaiDeep Kapur，联系Pi)。这些应用程序共同描述了 ESE治疗试验(ESETT)，旨在确定最有效和/或 通过比较三组患者，发现两岁以上患者的ESE治疗效果最差： 磷苯妥因(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、第三阶段比较有效性试验。至.为止 795名患者最初将以1：1：1的比例随机分配，并将进行响应自适应随机分配 在招募了300名患者之后。随机化将按三个年龄组分层，2- 18岁，19-65岁，66岁及以上。主要的结果衡量标准是停止临床治疗。 癫痫发作活动和改善精神状态，无严重不良反应或进一步 干预时间为给药后60min。每个主题都将被跟踪，直到 退伍或从注册之日起30天内退伍。这项试验将包括对早期成功的中期分析 而且徒劳无功。如果治疗的概率最大，则该试验将被认为是成功的 有效率大于0.975或治疗效果最差的概率更大 任何治疗都要比0.975美元多。这将是ESE在儿童中的第一次III期临床试验， 成年人。

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.