Study Stopped
low patient number after 2 years recruiting
HEAD-Study Optimizing the Treatment of Children With BECTS
HEAD
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
2 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 8, 2007
CompletedFirst Posted
Study publicly available on registry
May 10, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJanuary 29, 2009
January 1, 2009
May 8, 2007
January 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
6 months
Secondary Outcomes (3)
Safety and tolerability
6 months
Cognitive effects
6 months
Efficacy on EEG pattern
6 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. von Haunersches Kinderspital
München, 81371, Germany
Related Publications (1)
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.
PMID: 34554571DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
F Heinen, Prof.
Ludwigs-Maximilians-Universität München
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 8, 2007
First Posted
May 10, 2007
Study Start
June 1, 2006
Study Completion
July 1, 2008
Last Updated
January 29, 2009
Record last verified: 2009-01