HEAD-Study Optimizing the Treatment of Children With BECTS
This study has been terminated.
(low patient number after 2 years recruiting)
Sponsor:
Ludwig-Maximilians - University of Munich
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
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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:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
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:
- 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
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
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 Epilepsies, Partial Nervous System Diseases Etiracetam |
Sulthiame Anticonvulsants Central Nervous System Agents Nootropic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015