jRCT2031220265已完成不适用
A Phase III, multicenter, open-label study to evaluate the efficacy and safety of NRL-1 intranasally administered in Japanese pediatric patients with or at risk for status epilepticus
Aculys Pharma, Inc.0 个研究点目标入组 15 人开始时间: 2022年12月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Proportion of subjects with status epilepticus or with seizures that may progress to status epilepticus, who achieve seizure cessation after a single dose of intranasal NRL-1 without recurrence
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 6age old over 至 18age old not（—）
- 性别
- All
入选标准
- •Japanese pediatric patients with or at risk for status epilepticus
排除标准
- •Patients who in the opinion of the Investigator or Subinvestigator, previously failed to respond to diazepam injected within 5 minutes after onset of seizures
结局指标
主要结局
Proportion of subjects with status epilepticus or with seizures that may progress to status epilepticus, who achieve seizure cessation after a single dose of intranasal NRL-1 without recurrence
To evaluate the proportion of subjects with status epilepticus or with seizures that may progress to status epilepticus, who achieve seizure cessation after a single dose of intranasal NRL-1 without recurrence
次要结局
未报告次要终点
研究者
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