jRCTs051230107招募中不适用
Prophylactic Administration of Perampanel for Post-Stroke Epilepsy(PROPELLER study)
未提供0 个研究点目标入组 54 人开始时间: 2023年10月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 主要终点
- -
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
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 50age old over 至 90age old not(—)
- 性别
- All
入选标准
- •Patients with subcortical hemorrhage available for registration within 1 week
- •Patients'age at onset between 50 and 90 years
- •Patients capable of oral intake,including tube feeding
- •Patients who have been fully informed of the details of this clinical research and who have given their written consent,either by the research subject or by a surrogate
排除标准
- •Patients with a history of epilepsy
- •Patients taking antiepileptic drugs
- •Patients whose cerebral hemorrhage is known to be caused by a vascular malformation such as arteriovenous malformation or moyamoya disease, or is traumatic in nature
- •Patients with severe renal or hepatic impairment
- •Patients with pregnant or breast feeding
- •Patients with allergy to the target drug
- •Patients who are judged to be inappropriate as research subjects by the principal investigator (subinvestigator)
结局指标
主要结局
-
Percentage of epilepsy incidence in the first 3 years after initiation of protocol treatment.
次要结局
- All mortality(3 years after initiation of protocol treatment)
- Stroke(3 years after initiation of protocol treatment)
研究者
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