NCT03003143撤回不适用
Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients - A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Seizure frequency reduction
研究概览
简要总结
Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85
- •Possible autoimmune encephalitis
- •Patients who have been diagnosed and treated for encephalitis for more than 4 weeks
- •Patients with epilepsy (EEG finding or clinically)
排除标准
- •septic shock, fever >38.5 ℃, O2 saturation <90%, respiratory rate >25, HR >120
- •previously, mRS=3 or mRS>3
- •Patients who have terminal disease
- •eye problem
- •pregnancy
研究组 & 干预措施
Vigabatrin treatment group
Experimental
干预措施: Vigabatrin 500 MG (Drug)
结局指标
主要结局
Seizure frequency reduction
时间窗: 3 month of vigabatrin administration
50% reduction - favorable outcome
次要结局
- Modified Rankin Scale(3 month of vigabatrin administration)
- Depression (Beck Depression Inventory®-II)(3 month of vigabatrin administration)
- Cognition (Mini-Mental State Examination-Korean)(3 month of vigabatrin administration)
- Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)(after 3 month of vigabatrin administration)
- Sleep quality (Pittsburgh Sleep Quality Assessment)(3 month of vigabatrin administration)
研究者
Kon Chu
Professor
Seoul National University Hospital
研究点 (1)
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