Back to resultsHEAD-Study Optimizing the Treatment of Children With BECTS (HEAD)
Primary Purpose
Epilepsy, Rolandic
Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Treatment with levetiracetam or sulthiame over a six-month period.
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Rolandic focused on measuring benign epilepsy, pediatrics, children, rolandic epilepsy, levetiracetam, sulthiame
Eligibility 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
Sites / Locations
- Dr. von Haunersches Kinderspital
Outcomes
Primary Outcome Measures
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
Secondary Outcome Measures
Safety and tolerability
Cognitive effects
Efficacy on EEG pattern
Full Information
NCT ID
NCT00471744
First Posted
May 8, 2007
Last Updated
January 28, 2009
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00471744
Brief Title
HEAD-Study Optimizing the Treatment of Children With BECTS
Acronym
HEAD
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 Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
low patient number after 2 years recruiting
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Rolandic
Keywords
benign epilepsy, pediatrics, children, rolandic epilepsy, levetiracetam, sulthiame
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Treatment with levetiracetam or sulthiame over a six-month period.
Primary Outcome Measure Information:
Title
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
6 months
Title
Cognitive effects
Time Frame
6 months
Title
Efficacy on EEG pattern
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F Heinen, Prof.
Organizational Affiliation
Ludwigs-Maximilians-Universität München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. von Haunersches Kinderspital
City
München
ZIP/Postal Code
81371
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34554571
Citation
Milburn-McNulty P, Panebianco M, Marson AG. Sulthiame monotherapy for epilepsy. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD010062. doi: 10.1002/14651858.CD010062.pub3.
Results Reference
derived
Learn more about this trial
HEAD-Study Optimizing the Treatment of Children With BECTS
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