HEAD-Study Optimizing the Treatment of Children With BECTS
Phase 3
Terminated
- Conditions
- Epilepsy, Rolandic
- Registration Number
- NCT00471744
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame 6 months
- Secondary Outcome Measures
Name Time Method Safety and tolerability 6 months Cognitive effects 6 months Efficacy on EEG pattern 6 months
Trial Locations
- Locations (1)
Dr. von Haunersches Kinderspital
🇩🇪München, Germany