Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sulthiame.
- Who it may be relevant to
- Registry conditions: Importance of Interictal Epileptiform Activity on Sleep EEG, Epilepsy in Children. Basic parameters: 6 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG
Overview
The effect of sulthiame on EEG has been studied in epilepsy syndromes of childhood with sleep activation by comparing sleep EEG obtained at baseline and after 4 weeks of treatment. The aim of the study is to know if an effect is still identifiable after 2 weeks of treatment by performing sleep EEG recordings after 2 and 4 weeks of treatment, respectively.
Interventions
- Drug Sulthiame
Sulthiame add-on according to good clinical practice in these childhood epilepsy syndromes
Primary outcome measures
- Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG [Time frame: 14 days]
Eligibility criteria
Inclusion criteria
- Diagnosis of epilepsy syndromes of childhood with sleep activation
- Failure of at least two anti-epileptic drugs (AED)
- Sleep EEG performed in the last 7 days before inclusion and showing interictal epileptiform discharges (baseline EEG)
Exclusion criteria
- Previous trial with sulthiame
- More than 2 AED at inclusion
- Use of corticosteroids at inclusion
- Change in the anti-epileptic treatment in the 7 days before baseline EEG
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 3 centers
- Angers University Hospital, Pediatric department — Angers
- Strasbourg University Hospital, Pediatric department — Strasbourg
- Toulouse University Hospital, Pediatric Neurology Department — Toulouse
Identifiers
NCT: NCT05885646 · 49RC23_0073