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 - HEAD-STUDIE

• Conditions: Benign epilepsy of childhood with centro-temporal spikes (BECTS)

• Registration Number: EUCTR2005-004468-22-DE
• Lead Sponsor: Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunerschen Kinderspital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Age between 5 and 14 years
Weight between 15 kg and 60 kg
At least two preceeding seizures within the last 6 months before study start
Typical eeg with Rolando focus (centro-temporal spike/sharp-wave-focus)
Diagnosis of BECTS G 40.08
Written informed consent of parents and child
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Other forms of epilepsy (eg CSWS, Landau-Kleffner-syndrome)
Preceeding treatment with antiepileptic drugs
Mental Retardation (IQ < 85)
Focal neurological deficit
Relevant major internistic disease (eg hepatopathy, nephropathy, endocrinopathy. metabolic disorder, cardiovascular disease)
Participation in another clinical trial within the last 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the HEAD-STUDIE is to evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame;Secondary Objective: The secondary objectives of the HEAD-STUDIE are to evaluate the effects of the two treatment regimens on:<br>safety and tolerability<br>efficacy on eeg pattern<br>cognitive effects<br>correlation of changes of eeg patterns on cognition;Primary end point(s): The primary endpoint is efficacy: No treatment failure event (seizure) after reaching a steady state under aimed dosing conditions (from day 21 after begin of treatment)