TerminatedPhase 3

HEAD-Study Optimizing the Treatment of Children With BECTS

Stopped: low patient number after 2 years recruiting

Germany44 participantsStarted 2006-06

Plain-language 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.

Who can participate

Age range6 Years – 12 Years

SexALL

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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

What they're measuring

To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame

Timeframe: 6 months

Trial details

NCT IDNCT00471744

SponsorLudwig-Maximilians - University of Munich

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Epilepsy, Rolandic trials