HEAD-Study Optimizing the Treatment of Children With BECTS

Last updated: January 28, 2009
Sponsor: Ludwig-Maximilians - University of Munich
Overall Status: Terminated

Phase

3

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT00471744
2005-004468-22
ISRCTN 97864911
  • Ages 6-12
  • All Genders

Study 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 Criteria

Inclusion

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 orsharp-wave-focus)

  5. Diagnosis of BECTS

  6. Written informed consent from parents and child

Exclusion

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

Study Design

Total Participants: 44
Study Start date:
June 01, 2006
Estimated Completion Date:
July 31, 2008

Connect with a study center

  • Dr. von Haunersches Kinderspital

    München, 81371
    Germany

    Site Not Available

  • Dr. von Haunersches Kinderspital

    München, 81371
    Germany

    Site Not Available

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