jRCT2080224539已完成3 期
Phase 3 Clinical Trial of AF-0901 - Open-label study in patients aged 15 years old or more with convulsive status epilepticus -
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Achievement of convulsive seizure cessation
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Uncontrolled, open-label, multi-center study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 15age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with a convulsive seizures episode lasting for 5 min or longer at the beginning of first intravenous bolus injection
排除标准
- •Patients with current or previous history of psychogenic non-epileptic seizure, those with acute narrow angle glaucoma or myasthenia gravis, those receiving combination therapy with an HIV protease inhibitor, formulation contaning efavirenz or cobicistat, and those with a hypersensitivity to midazolam or benzodiazepine.
结局指标
主要结局
Achievement of convulsive seizure cessation
时间窗: final assessment
Achievement of convulsive seizure cessation in the final assessment of bolus intravenous injection
次要结局
- Achievement of convulsive seizure cessation in the final treatment assessment(Bolus intravenous injection period only)
- Recurrence of convulsive seizures in the final assessment during the post-treatment observation period(24 hours after the end of the last dose)
研究者
研究点 (1)
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