HEAD-Study Optimizing the Treatment of Children With BECTS

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
  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
Endpoint Classification: Efficacy Study
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:


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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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

No publications provided

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
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

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Rolandic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Sulthiame
Etiracetam
Anticonvulsants
Piracetam
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014