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

This study has been terminated.
(low patient number after 2 years recruiting)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471744
First Posted: May 10, 2007
Last Update Posted: January 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ludwig-Maximilians - University of Munich
  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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 8, 2007
First Posted: May 10, 2007
Last Update Posted: January 29, 2009
Last Verified: January 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