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Sponsored by: |
Ludwig-Maximilians - University of Munich |
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Information provided by: | Ludwig-Maximilians - University of Munich |
ClinicalTrials.gov Identifier: | NCT00471744 |
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 |
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Epilepsy, Rolandic |
Drug: Treatment with levetiracetam or sulthiame over a six-month period. |
Phase III |
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 |
Enrollment: | 44 |
Study Start Date: | June 2006 |
Study Completion Date: | July 2008 |
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Dr. von Haunersches Kinderspital | |
München, Germany, 81371 |
Principal Investigator: | F Heinen, Prof. | Ludwigs-Maximilians-Universität München |
Study ID Numbers: | 2005-004468-22, ISRCTN 97864911 |
Study First Received: | May 8, 2007 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00471744 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
benign epilepsy pediatrics children |
rolandic epilepsy levetiracetam sulthiame |
Epilepsies, Partial Nootropic Agents Sulthiame Epilepsy, Rolandic Epilepsy |
Central Nervous System Diseases Etiracetam Brain Diseases Anticonvulsants |
Epilepsies, Partial Nootropic Agents Epilepsy, Rolandic Nervous System Diseases Central Nervous System Diseases Brain Diseases Pharmacologic Actions |
Sulthiame Epilepsy Therapeutic Uses Etiracetam Central Nervous System Agents Anticonvulsants |