TCTR20200717002已完成2 期
Efficacy and safety of oral micronized progesterone that converts to allopregnanolone as an adjunctive treatment in refractory status epilepticus (Phase IIa study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1.Adults, age 18â€80 years old
- •2.Diagnosed with either convulsive or non-convulsive RSE
- •3.Receiving standard AED treatment, including intravenous midazolam, for longer than 60 minutes
排除标准
- •1.Pregnancy or lactation
- •2.Serious medical problems; renal failure on dialysis, metastatic cancer, active thromboembolism, active bleeding, elevated transaminase enzymes ≥ five times of normal value (> 160 U/L), blood pressure lower than 80/50 mmHg
- •3.Absolute NPO (as the studied drug was an enteric tubal formulation)
- •4.Receiving drugs with potential major interaction with progesterone (e.g. estrogen, edoxaban, and venetoclax)
研究者
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