NCT05885646

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

May 22, 2023

Last Update Submit

June 12, 2025

Conditions

Importance of Interictal Epileptiform Activity on Sleep EEGEpilepsy in Children

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG

    14 days

Interventions

SulthiameDRUG

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

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

-Children with pharmaco-resistant epilepsy

You may qualify if:

  • Diagnosis of epilepsy syndromes of childhood with sleep activation
  • Failure of at least two anti-epileptic drugs (AED)

You may not qualify if:

  • Previous trial with sulthiame
  • Change in the anti-epileptic treatment in the 7 days before baseline EEG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Angers University Hospital, Pediatric department

Angers, 49000, France

RECRUITING

Strasbourg University Hospital, Pediatric department

Strasbourg, 67000, France

NOT YET RECRUITING

Toulouse University Hospital, Pediatric Neurology Department

Toulouse, 31000, France

NOT YET RECRUITING

MeSH Terms

Interventions

sulthiame

Study Officials

  • Patrick Van Bogaert, Professor

    Angers University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Van Bogaert, Professor

CONTACT

02.41.35.48.46Patrick.VanBogaert@chu-angers.fr

Elsa Berardi

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 2, 2023

Study Start

October 17, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)