NCT00471744终止3 期
HEAD-TO-HEAD Evaluation of the Antiepileptic Drugs Levetiracetam (LEV) vs. Sulthiame (STM) in a German Multi-Centre, Doubleblind Controlled Trial in Children With Benign Epilepsy With Centro-Temporal Spikes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
研究概览
简要总结
The investigators hypothesize that Levetiracetam is as effective as Sulthiame in the treatment of children with BECTS. Patients entering the HEAD-Studie are either treated with Leveitracetam or Sulthiame over a 6 months period. Patients are equally randomised to one of the two treatment regimens. Administration of medication as blinded capsules.
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
- Double
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 12 years
- •Weight between 15 kg and 60 kg
- •At least two preceding seizures within the last six months before study start
- •Typical electroencephalogram (EEG) with Rolando focus (centrotemporal spike or sharp-wave-focus)
- •Diagnosis of BECTS
- •Written informed consent from parents and child
排除标准
- •Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep [CSWS], Landau-Kleffner-syndrome)
- •Preceding treatment with antiepileptic drugs
- •Mental Retardation (intelligence quotient [IQ] <85)
- •Focal neurological deficit
- •Relevant major internistic disease (e.g. hepatopathy, nephropathy, endocrinopathy)
- •Participation in another clinical trial within the last 30 days
结局指标
主要结局
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
时间窗: 6 months
次要结局
- Safety and tolerability(6 months)
- Cognitive effects(6 months)
- Efficacy on EEG pattern(6 months)
研究者
研究点 (2)
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