Status1 Cohort Assignment Dataset in Use of Lorazepam for the Treatment of Pediatric Status Epilepticus

Data on cohort assignment
Study Description
An open-label, multi-center study to evaluate the single dose pharmacokinetics of intravenous lorazepam in pediatric patients aged 3 months to less than 18 years treated for status epilepticus (SE) or with a history of SE. Cohort assignment was based on medical history: Cohort 1 included Emergency Department or hospital patients in SE receiving lorazepam; Cohort 2 included patients with epilepsy admitted for an elective dose of lorazepam. Subjects were stratified by age in each cohort. Participants in Cohort 1 received lorazepam 0.1 mg/kg up to a maximum dose of 4 mg/kg. Participants in Cohort 2 received lorazepam 0.05 mg/kg up to a maximum dose of 2 mg/kg. This study was conducted under the Best Pharmaceuticals for Children Act Program. Children ages 3 months to less than 18 years with status epilepticus or a history of status epilepticus

队列分组相关数据
研究概况
本研究为一项开放标签多中心研究，旨在评估3个月至不足18岁、因癫痫持续状态（status epilepticus, SE）接受治疗或有癫痫持续状态病史的儿科患者静脉注射劳拉西泮（lorazepam）的单剂量药代动力学特征。队列分组依据受试者病史确定：队列1纳入急诊科或住院部确诊癫痫持续状态并接受劳拉西泮治疗的患者；队列2纳入因择期劳拉西泮给药需求入院的癫痫患者。各队列均按年龄进行分层。队列1受试者接受劳拉西泮给药剂量为0.1mg/kg，最大给药剂量不超过4mg/kg；队列2受试者接受劳拉西泮给药剂量为0.05mg/kg，最大给药剂量不超过2mg/kg。本研究依据《儿童最佳药品法案计划》（Best Pharmaceuticals for Children Act Program）开展，纳入人群为3个月至不足18岁、确诊癫痫持续状态或有癫痫持续状态病史的儿童。