HEAD-Study Optimizing the Treatment of Children With BECTS

HEAD-TO-HEAD Evaluation of the Antiepileptic Drugs Levetiracetam (LEV) vs. Sulthiame (STM) in a German Multi-Centre, Doubleblind Controlled Trial in Children With Benign Epilepsy With Centro-Temporal Spikes

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00471744

Acronym

HEAD

Enrollment

Registered

2007-05-10

Start date

2006-06-30

Completion date

2008-07-31

Last updated

2009-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Rolandic

Keywords

benign epilepsy, pediatrics, children, rolandic epilepsy, levetiracetam, sulthiame

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.

Interventions

DRUGTreatment with levetiracetam or sulthiame over a six-month period.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

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

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame	6 months

Secondary

Measure	Time frame
Safety and tolerability	6 months
Cognitive effects	6 months
Efficacy on EEG pattern	6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026