Importance of Interictal Epileptiform Activity on Sleep EEGSURFNCT05885646
Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes
An observational study of Importance of Interictal Epileptiform Activity on Sleep EEG and Epilepsy in Children, run by University Hospital, Angers at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Importance of Interictal Epileptiform Activity on Sleep EEG, Epilepsy in Children
- What is being tested?
- Sulthiame
- How many people
- 15 participants
- Where
- 3 sitesFrance
- Study dates
- 17 Oct 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Child
Study population: -Children with pharmaco-resistant epilepsy
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Elsa Berardi contact
France3 sites, 3 recruiting
- Recruiting
Angers University Hospital, Pediatric department
Angers, 49000
Patrick Van Bogaert, Professor, 02 41 35 48 46, Patrick.VanBogaert@chu-angers.fr
Elsa Berardi, ElBerardi@chu-angers.fr
- Not yet recruiting
Strasbourg University Hospital, Pediatric department
Strasbourg, 67000
Anne de Saint-Martin, Doctor, Anne.DESAINTMARTIN@chru-strasbourg.fr
Salomé Hemar, salome.hemar@chru-strasbourg.fr
- Not yet recruiting
Toulouse University Hospital, Pediatric Neurology Department
Toulouse, 31000
Caroline Hachon-Le Camus, Doctor, hachonlecamus.c@chu-toulouse.fr
About this study
Official title: Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG
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.
- Being tested
- Sulthiame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulthiameDrug
Sulthiame add-on according to good clinical practice in these childhood epilepsy syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start17 Oct 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Importance of Interictal Epileptiform Activity on Sleep EEGStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Patrick Van Bogaert, Professor, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885646
- Sponsor's protocol ID
- 49RC23_0073
- Acronym
- SURF
- Status last verified
- Jun 2025
- First submitted
- 22 May 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG
- ClinicalTrials.gov ID
- NCT05885646
- Acronym / sponsor ID
- SURF / 49RC23_0073
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- -Children with pharmaco-resistant epilepsy
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulthiameSulthiame add-on according to good clinical practice in these childhood epilepsy syndromes | Drug | – |
Primary outcome
Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elsa Berardi contact
Patrick Van Bogaert, Professor principal investigator
University Hospital, Angers
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Importance of Interictal Epileptiform Activity on Sleep EEG and Epilepsy in Children, run by University Hospital, Angers at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Van Bogaert, Professor (02.41.35.48.46, Patrick.VanBogaert@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.