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HEAD-Study Optimizing the Treatment of Children With BECTS | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

NCT00471744•Ludwig-Maximilians - University of Munich

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 12 years

Sex

ALL

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

Locations (1)

Dr. von Haunersches Kinderspital

München, Germany

Key Dates

Start Date

June 1, 2006

Completion Date

July 1, 2008

Last Updated

January 29, 2009

Enrollment

ACTUAL participants

Conditions

Epilepsy, Rolandic

Interventions

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

DRUG