EUCTR2005-004468-22-DE进行中（未招募）不适用
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 - HEAD-STUDIE
Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital0 个研究点目标入组 120 人开始时间: 2006年8月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age between 5 and 14 years
- •Weight between 15 kg and 60 kg
- •At least two preceeding seizures within the last 6 months before study start
- •Typical eeg with Rolando focus (centro-temporal spike/sharp-wave-focus)
- •Diagnosis of BECTS G 40.08
- •Written informed consent of parents and child
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Other forms of epilepsy (eg CSWS, Landau-Kleffner-syndrome)
- •Preceeding treatment with antiepileptic drugs
- •Mental Retardation (IQ < 85)
- •Focal neurological deficit
- •Relevant major internistic disease (eg hepatopathy, nephropathy, endocrinopathy. metabolic disorder, cardiovascular disease)
- •Participation in another clinical trial within the last 30 days
研究者
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