HEAD-to-head evaluation of the antiepileptic drugs, levetiracetam versus sulthiame in a German multicentre, double-blind, controlled trial in children with benign epilepsy with centrotemporal spikes

Completed

• Conditions: Benign epilepsy of childhood with centrotemporal spikes (BECTS); Nervous System Diseases; Benign epilepsy of childhood with centrotemporal spikes

• Registration Number: ISRCTN97864911
• Lead Sponsor: Hospital of the University of Munich, Dr. von Haunerschen Children?s Hospital (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-21
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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 (=8 years)

Inclusion criteria added/changed as of 08/05/2007:
1. Age between 5 and 14 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 (=8 years)

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame

Secondary Outcome Measures

Name	Time	Method
1. Safety and tolerability<br>2. Efficacy on EEG pattern<br>3. Cognitive effects