HEAD-Study Optimizing the Treatment of Children With BECTS

This study is currently recruiting participants.

Verified by Ludwig-Maximilians - University of Munich, May 2007

Sponsored by:	Ludwig-Maximilians - University of Munich
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00471744

Purpose

We 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	Intervention	Phase
Epilepsy, Rolandic	Drug: Treatment with levetiracetam or sulthiame over a six-month period.	Phase III

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Levetiracetam Sulthiame

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	5 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 5 and 14 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471744

Contacts

Contact: F Heinen, Prof.	0049-89-5160 ext 7851	florian.heinen@med.uni-muenchen.de
Contact: M Bonfert	0049-89-5160 ext 7852	michaela.bonfert@med.uni-muenchen.de

Locations

Germany
Dr. von Haunersches Kinderspital	Recruiting
München, Germany, 81371

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Investigators

Principal Investigator:

F Heinen, Prof.

Ludwigs-Maximilians-Universität München

More Information

Study ID Numbers:	2005-004468-22, ISRCTN 97864911
Study First Received:	May 8, 2007
Last Updated:	May 8, 2007
ClinicalTrials.gov Identifier:	NCT00471744
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:

benign epilepsy
pediatrics
children

rolandic epilepsy
levetiracetam
sulthiame

Study placed in the following topic categories:

Epilepsies, Partial
Sulthiame
Epilepsy, Rolandic
Epilepsy

Central Nervous System Diseases
Etiracetam
Brain Diseases

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Nervous System Diseases

Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009