HEAD-Study Optimizing the Treatment of Children With BECTS

Ludwig Maximilian University of Munich

Status and phase: Terminated; Phase 3

Conditions: Epilepsy, Rolandic

Treatments: Drug: Treatment with levetiracetam or sulthiame over a six-month period.

Study type: Interventional

Funder types: Other

Identifiers

NCT00471744

2005-004468-22

ISRCTN 97864911

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind