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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy in Children
• Epileptic Syndromes

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