HEAD-Study Optimizing the Treatment of Children With BECTS (HEAD)

This study has been terminated.

(low patient number after 2 years recruiting)

Sponsor:

Information provided by:

Ludwig-Maximilians - University of Munich

ClinicalTrials.gov Identifier:

NCT00471744

First received: May 8, 2007

Last updated: January 28, 2009

Last verified: January 2009

History of Changes

Purpose

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: epilepsy-aphasia spectrum pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Levetiracetam

U.S. FDA Resources

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 ]


Enrollment:	44
Study Start Date:	June 2006
Study Completion Date:	July 2008

Eligibility


Ages Eligible for Study:	6 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Germany
Dr. von Haunersches Kinderspital
München, Germany, 81371

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Investigators


Principal Investigator:	F Heinen, Prof.	Ludwigs-Maximilians-Universität München

More Information


ClinicalTrials.gov Identifier:	NCT00471744 History of Changes
Other Study ID Numbers:	2005-004468-22 ISRCTN 97864911
Study First Received:	May 8, 2007
Last Updated:	January 28, 2009

Keywords provided by Ludwig-Maximilians - University of Munich:


benign epilepsy pediatrics children	rolandic epilepsy levetiracetam sulthiame

Additional relevant MeSH terms:


Epilepsy Epilepsy, Rolandic Brain Diseases Central Nervous System Diseases Nervous System Diseases Epilepsies, Partial Etiracetam	Sulthiame Piracetam Anticonvulsants Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017

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