HEAD-Study Optimizing the Treatment of Children With BECTS

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Treatments: Etiracetam; Levetiracetam; Piracetam; Sulthiame

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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