NCT03940326已完成4 期
Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Seizure Freedom Rate
研究概览
简要总结
This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months
- •Normal brain MRI or MRI without epileptogenic lesion
- •Normal electroencephalography(EEG) or existence of generalized epileptiform discharges without any focal epileptiform discharges.
- •Signing consent form
排除标准
- •History of treatment by sodium valproate or levetiracetam
- •History of treatment by any anti-epileptic drug in last 6 months
- •Plan for pregnancy
- •Using no certain contraceptive method
- •History of past or current hepatic disease
- •History of past or current renal disease
- •History of past or current hematologic disease
- •History of known psychiatric disease
- •History of status epilepticus
研究组 & 干预措施
Levetiracetam
Experimental
干预措施: Levetiracetam (Drug)
Valproate
Active Comparator
干预措施: Valproate (Drug)
结局指标
主要结局
Seizure Freedom Rate
时间窗: 6 months
Time to First Seizure
时间窗: 6 months
The time interval from the beginning of the study to occurrence of the first seizure
次要结局
- Withdrawal Rate(6 months)
- Time to Withdrawal(9 months)
研究者
Nasim Tabrizi
Assistant professor of neurology
Mazandaran University of Medical Sciences
研究点 (1)
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