SURF: Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05885646
• Collaborator: (none)
• Enrollment: 15
• Anticipated Duration (Months): 14.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Importance of Interictal Epileptiform Activity on Sleep EEG	Drug: Sulthiame

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Outcome Measures

Primary Outcome Measures

1. Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG [14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 15 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT05885646
• Other Study ID Numbers: 49RC23_0073
• First Posted: Jun 2, 2023
• Last Update Posted: Jun 2, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epilepsy; Epileptic Syndromes; Sulthiame

Study Results

No Results Posted as of Jun 2, 2023