Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes

NCT ID: NCT05885646

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-17

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Importance of Interictal Epileptiform Activity on Sleep EEG Epilepsy in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Sulthiame

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Van Bogaert, Professor

Role: PRINCIPAL_INVESTIGATOR

Angers University Hospital

Locations

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Angers University Hospital, Pediatric department

Angers, , France

Site Status RECRUITING

Strasbourg University Hospital, Pediatric department

Strasbourg, , France

Site Status NOT_YET_RECRUITING

Toulouse University Hospital, Pediatric Neurology Department

Toulouse, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Patrick Van Bogaert, Professor

Role: CONTACT

02.41.35.48.46

Elsa Berardi

Role: CONTACT

Facility Contacts

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Patrick Van Bogaert, Professor

Role: primary

02 41 35 48 46

Elsa Berardi

Role: backup

Anne de Saint-Martin, Doctor

Role: primary

Salomé Hemar

Role: backup

Caroline Hachon-Le Camus, Doctor

Role: primary

Other Identifiers

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49RC23_0073

Identifier Type: -

Identifier Source: org_study_id

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