ISRCTN97864911.

Study name	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
Methods	Randomised, double‐blind, active‐controlled, parallel trial. Six‐month treatment period
Participants	Inclusion criteria Age between five and 14 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 (if child is 8 years of age or older) Exclusion criteria 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
Interventions	Sulthiame versus levetiracetam
Outcomes	Primary outcome "To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame". No further information on the primary outcome of this study is given Secondary outcomes Safety and tolerability Efficacy on EEG pattern Cognitive effects
Starting date	1 June 2006
Contact information	florian.heinen@med.uni‐muenchen.de
Notes