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NCT05885646 Clinical Trial

Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes

Epilepsy in Children Clinical Trial

— SURF  

Official title:
Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05885646
Other study ID # 49RC23_0073
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2023
Est. completion date September 2024

Study information
Verified date January 2024
Source University Hospital, Angers
Contact Patrick Van Bogaert, Professor
Phone 02.41.35.48.46
Email Patrick.VanBogaert@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date September 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 6 Years to 15 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sulthiame
Sulthiame add-on according to good clinical practice in these childhood epilepsy syndromes

Locations
Country Name City State
France Angers University Hospital, Pediatric department Angers
France Strasbourg University Hospital, Pediatric department Strasbourg
France Toulouse University Hospital, Pediatric Neurology Department Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG 14 days
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