HEAD-Study Optimizing the Treatment of Children With BECTS (HEAD)
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ClinicalTrials.gov Identifier: NCT00471744
Recruitment Status :
(low patient number after 2 years recruiting)
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.
Condition or disease
Drug: Treatment with levetiracetam or sulthiame over a six-month period.
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
Study Start Date :
Actual Study Completion Date :
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Ages Eligible for Study:
6 Years to 12 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep [CSWS], Landau-Kleffner-syndrome)