Evaluating the effects of sulthiame on EEG in children with epilepsy
Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG
This study tests if the medication sulthiame can change sleep brain activity in children with epilepsy who haven't had success with other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 3 sites (Angers and 2 other locations) |
| Trial ID | NCT05885646 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of sulthiame on sleep EEG in children diagnosed with epilepsy syndromes characterized by sleep activation. Participants will undergo sleep EEG recordings at baseline and after 2 and 4 weeks of treatment to assess any changes in interictal epileptiform activity. The study aims to determine if the effects of sulthiame can be identified after two weeks of treatment, providing insights into its efficacy in managing childhood epilepsy. The study includes children who have previously failed at least two anti-epileptic drugs.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with epilepsy syndromes that exhibit sleep activation and have not responded to at least two anti-epileptic medications.
Not a fit: Patients who have previously participated in a trial with sulthiame or are currently using corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the effectiveness of sulthiame in reducing epileptiform activity in children with epilepsy.
How similar studies have performed: While the specific effects of sulthiame on EEG in childhood epilepsy have not been extensively studied, similar approaches in evaluating anti-epileptic drugs have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Angers and 2 other locations
- Angers University Hospital, Pediatric department — Angers, France (Recruiting)
- Strasbourg University Hospital, Pediatric department — Strasbourg, France (Not_yet_recruiting)
- Toulouse University Hospital, Pediatric Neurology Department — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Patrick Van Bogaert, Professor — University Hospital, Angers
- Study coordinator: Patrick Van Bogaert, Professor
- Email: Patrick.VanBogaert@chu-angers.fr
- Phone: 02.41.35.48.46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.