Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes

Recruiting

• Conditions: Epilepsy in Children; Importance of Interictal Epileptiform Activity on Sleep EEG

• Registration Number: NCT05885646
• Lead Sponsor: University Hospital, Angers

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-02
• Study Start: 2023-10-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2024-10-17
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG	14 days

Trial Locations

Locations (3)

Strasbourg University Hospital, Pediatric department; 🇫🇷 Strasbourg, France

Angers University Hospital, Pediatric department; 🇫🇷 Angers, France

Toulouse University Hospital, Pediatric Neurology Department; 🇫🇷 Toulouse, France