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

- To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame [ Time Frame: 6 months ]
- Safety and tolerability [ Time Frame: 6 months ]
- Cognitive effects [ Time Frame: 6 months ]
- Efficacy on EEG pattern [ Time Frame: 6 months ]

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

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
Germany | |
Dr. von Haunersches Kinderspital | |
München, Germany, 81371 |
Principal Investigator: | F Heinen, Prof. | Ludwigs-Maximilians-Universität München |
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 |
benign epilepsy pediatrics children |
rolandic epilepsy levetiracetam sulthiame |
Epilepsy Epilepsy, Rolandic Brain Diseases Central Nervous System Diseases Nervous System Diseases Epilepsies, Partial |
Epileptic Syndromes Levetiracetam Sulthiame Anticonvulsants Nootropic Agents |