HEAD-Study Optimizing the Treatment of Children With BECTS

Epilepsy, Rolandic Clinical Trial

— HEAD  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00471744
• Other study ID #: 2005-004468-22
• Secondary ID: ISRCTN 97864911
• Status: Terminated
• Phase: Phase 3
• First received: May 8, 2007
• Last updated: January 28, 2009
• Start date: June 2006
• Est. completion date: July 2008

Study information

• Verified date: January 2009
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Rolandic

Intervention

Drug:
• Treatment with levetiracetam or sulthiame over a six-month period.

Locations

Country	Name	City	State
Germany	Dr. von Haunersches Kinderspital	München

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame		6 months
Secondary	Safety and tolerability		6 months
Secondary	Cognitive effects		6 months
Secondary	Efficacy on EEG pattern		6 months