Benign epilepsy of childhood with centrotemporal spikes (BECTS) Nervous System Diseases Benign epilepsy of childhood with centrotemporal spikes
Conditions
Interventions
Patients entering the HEAD-STUDIE are either treated with levetiracetam or sulthiame over a six-month period. Patients are equally randomised to one of the two treatment regimens. Administration of me
Sponsors
Hospital of the University of Munich, Dr. von Haunerschen Children?s Hospital (Germany)
Eligibility
Sex/Gender
All
Inclusion 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 (=8 years) Inclusion criteria added/changed as of 08/05/2007: 1. Age between 5 and 14 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 (=8 years)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability 2. Efficacy on EEG pattern 3. Cognitive effects | — |
Countries
Germany
Outcome results
None listed