NCT05291455Unknown3 期
Efficacy of Lacosamide in Neonatal Status Epilepticus: A Randomized Controlled Study
Sherief Abd-Elsalam1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- number of children with cessation or improved duration of status epilepticus
研究概览
简要总结
Lacosamide in neonatal status epilepticus
详细描述
The study will assess the efficacy of Lacosamide in neonatal status epilepticus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neonates with status epilepticus
排除标准
- •congenital anomalies or organ dysfunction
研究组 & 干预措施
Lacosamide
Experimental
Lacosamide will be given.
干预措施: Lacosamide (Drug)
Phenobarbitone
Active Comparator
Phenobarbital will be given
干预措施: Phenobarbital (Drug)
结局指标
主要结局
number of children with cessation or improved duration of status epilepticus
时间窗: 1 year
the number of children with cessation or improved duration of status epilepticus
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
ass prof tropical medicine
Tanta University
研究点 (1)
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