Status1 Visit Date Dataset in Use of Lorazepam for the Treatment of Pediatric Status Epilepticus

Data on study visit date and time
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

研究访视日期与时间数据
研究概况
本研究为一项开放标签（open-label）、多中心（multi-center）临床试验，旨在评估3月龄至18岁以下因癫痫持续状态（status epilepticus, SE）接受治疗或有癫痫持续状态病史的儿童患者静脉注射劳拉西泮（lorazepam）的单剂量药代动力学（pharmacokinetics）。队列分配基于受试者病史：队列1纳入急诊科室或住院期间处于癫痫持续状态且接受劳拉西泮治疗的患者；队列2纳入因择期给予劳拉西泮而入院的癫痫患者。各队列均按年龄对受试者进行分层。队列1受试者接受劳拉西泮剂量为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，纳入对象为3月龄至18岁以下存在癫痫持续状态或有癫痫持续状态病史的儿童。