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Open-Label Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

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Trial Profile

Open-Label Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 May 2024

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At a glance

  • Drugs Cenobamate (Primary)
  • Indications Partial epilepsies; Seizures
  • Focus Adverse reactions; Registrational
  • Sponsors SK Life Science

    • Most Recent Events

    • 11 Apr 2024 According to a SK Life Science media release, based on data from this study, U.S. Food and Drug Administration approved two new administration options of cenobamate tablets an antiseizure medication for adults with partial onset (focal) seizures, which can now be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube.
    • 23 Mar 2023 Status changed from active, no longer recruiting to recruiting.
    • 20 Dec 2022 Planned End Date changed from 1 Sep 2024 to 1 Jul 2026.
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