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

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ClinicalTrials.gov Identifier: NCT00471744
Recruitment Status : Terminated (low patient number after 2 years recruiting)
First Posted : May 10, 2007
Last Update Posted : January 29, 2009
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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
Study Start Date : June 2006
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 6 months ]
  2. Cognitive effects [ Time Frame: 6 months ]
  3. Efficacy on EEG pattern [ Time Frame: 6 months ]

Eligibility Criteria
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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
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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
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Germany
Dr. von Haunersches Kinderspital
München, Germany, 81371
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Principal Investigator: F Heinen, Prof. Ludwigs-Maximilians-Universität München
More Information
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ClinicalTrials.gov Identifier: NCT00471744    
Other Study ID Numbers: 2005-004468-22
ISRCTN 97864911
First Posted: May 10, 2007    Key Record Dates
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:
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Epilepsy
Epilepsy, Rolandic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
 Epileptic Syndromes
Levetiracetam
Sulthiame
Anticonvulsants
Nootropic Agents