NCT05885646RecruitingNot Applicable
Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG
University Hospital, Angers3 sites in 1 country15 target enrollmentStarted: October 17, 2023Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 3
- Primary Endpoint
- Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG
Time Frame: 14 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Clinic-based and Technology-Supported Sleep Intervention for Pediatric EpilepsyEpilepsyNCT06661759National Taiwan University Hospital150
Completed
Phase 2
Getting SMART for Pediatric EpilepsyEpilepsy in ChildrenNCT05439876National Taiwan University Hospital147
Recruiting
Not Applicable
Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.Benign Epilepsy With Centro Temporal Spikes (BECTS)Atypical Benign Partial Epilepsy (ABPE)Epileptic Encephalopathy With Continuous Spike and Waves During Sleep (ECSWS)NCT03865771University Hospital, Strasbourg, France95
Withdrawn
Not Applicable
Sleep Spindles and Memory in Rolandic EpilepsyRolandic EpilepsyRolandic Epilepsy, BenignCentrotemporal EpilepsyEEG Spikes, Epilepsy of Childhood CentrotemporalSeizure EpilepsyEpilepsyNCT04569708Massachusetts General Hospital100
Unknown
Not Applicable
Sleep Problems in Epileptic Children and Their CaregiversEpileptic Children,Sleep Disturbances,Maladaptive BehaviorsNCT05191576Ege University120