Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes | NCT05885646

Studies
Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes

NCT05885646

Sponsor

University Hospital, Angers

Status

Recruiting

Last Update Posted

Jun 15, 2025Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Importance of Interictal Epileptiform Activity on Sleep EEG
Epilepsy in Children

Interventions

Sulthiame

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2023Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

May 22, 2023

First Submission Date that Met QC Criteria

May 22, 2023

First Posted Date

Jun 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2025

Last Update Posted Date

Jun 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sulthiame	Drug	Sulthiame add-on according to good clinical practice in these childhood epilepsy syndromes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG		14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

-Children with pharmaco-resistant epilepsy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick Van Bogaert, Professor	Contact	02.41.35.48.46		Patrick.VanBogaert@chu-angers.fr
Elsa Berardi	Contact

Overall Officials

Name	Affiliation	Role
Patrick Van Bogaert, Professor	University Hospital, Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Angers University Hospital, Pediatric department	Recruiting	Angers		49000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C084593	sulthiame

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided