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NCT Number: NCT05885646

Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes

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.

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Key information

Conditions

Importance of Interictal Epileptiform Activity on Sleep EEG Epilepsy in Children

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Pediatric department, Angers, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulthiame

Drug

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

Primary outcomes

  1. Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG

    Time frame: 14 days

Study contacts

Contact information is provided by the study sponsor or research team.

Elsa Berardi

CONTACT

Patrick Van Bogaert, Professor

CONTACT

[email protected]

02.41.35.48.46

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG

Acronym: SURF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2023
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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