Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-15
SponsorUniversity Hospital, Angers
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
-Children with pharmaco-resistant epilepsy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sulthiame
DrugSulthiame add-on according to good clinical practice in these childhood epilepsy syndromes
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG
Time frame
14 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov