ISRCTN97864911已完成不适用

HEAD-to-head evaluation of the antiepileptic drugs, levetiracetam versus sulthiame in a German multicentre, double-blind, controlled trial in children with benign epilepsy with centrotemporal spikes

Hospital of the University of Munich, Dr. von Haunerschen Children?s Hospital (Germany)0 个研究点目标入组 120 人开始时间: 2006年4月21日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Age between 6 and 12 years
•2. Weight between 15 kg and 60 kg
•3. At least two preceding seizures within the last six months before study start
•4. Typical electroencephalogram (EEG) with Rolando focus (centrotemporal spike or sharp-wave-focus)
•5. Diagnosis of BECTS
•6. Written informed consent from parents and child (=8 years)
•Inclusion criteria added/changed as of 08/05/2007:
•1. Age between 5 and 14 years
•2. Weight between 15 kg and 60 kg
•3. At least two preceding seizures within the last six months before study start
•4. Typical electroencephalogram (EEG) with Rolando focus (centrotemporal spike or sharp-wave-focus)
•5. Diagnosis of BECTS
•6. Written informed consent from parents and child (=8 years)

•1. Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep [CSWS], Landau-Kleffner-syndrome)
•2. Preceding treatment with antiepileptic drugs
•3. Mental Retardation (intelligence quotient [IQ] <85)
•4. Focal neurological deficit
•5. Relevant major internistic disease (e.g. hepatopathy, nephropathy, endocrinopathy)
•6. Participation in another clinical trial within the last 30 days

发起方

Hospital of the University of Munich, Dr. von Haunerschen Children?s Hospital (Germany)