Status:
TERMINATED
HEAD-Study Optimizing the Treatment of Children With BECTS
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Conditions:
Epilepsy, Rolandic
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
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 Sulthi...
Eligibility Criteria
Inclusion
- Age between 6 and 12 years
- Weight between 15 kg and 60 kg
- At least two preceding seizures within the last six months before study start
- Typical electroencephalogram (EEG) with Rolando focus (centrotemporal spike or sharp-wave-focus)
- Diagnosis of BECTS
- Written informed consent from parents and child
Exclusion
- Other forms of epilepsy (e.g. continuous spikes and waves during slow sleep \[CSWS\], Landau-Kleffner-syndrome)
- Preceding treatment with antiepileptic drugs
- Mental Retardation (intelligence quotient \[IQ\] \<85)
- Focal neurological deficit
- Relevant major internistic disease (e.g. hepatopathy, nephropathy, endocrinopathy)
- Participation in another clinical trial within the last 30 days
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00471744
Start Date
June 1 2006
End Date
July 1 2008
Last Update
January 29 2009
Active Locations (1)
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1
Dr. von Haunersches Kinderspital
München, Germany, 81371