HEAD-Study Optimizing the Treatment of Children With BECTS

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Terminated

CT.gov ID

NCT00471744

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy, Rolandic	Drug: Treatment with levetiracetam or sulthiame over a six-month period.	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Study Completion Date :

Jul 1, 2008

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame [6 months]

Secondary Outcome Measures

Safety and tolerability [6 months]
Cognitive effects [6 months]
Efficacy on EEG pattern [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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