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A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2025

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At a glance

  • Drugs Cenobamate (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Sponsors SK biopharmaceuticals

Most Recent Events

  • 17 Nov 2025 According to SK Life Science media release, announced the recent publication of three peer-reviewed articles evaluating the efficacy and safety of adjunctive cenobamate in adult Asian patients with uncontrolled focal seizures and The articles are based on findings from this study.
  • 05 Nov 2025 According to SK Life Science media release, on 3 Nov, Dong-A ST's NDA for cenobamate submitted to the Korean Ministry of Food and Drug Safety was approved. Following the submission of an NDA by Ignis Therapeutics in China at the end of last year, Japanese partner Ono Pharmaceutical Industry submitted an NDA to Japan in September, and it is expected that the expansion into the three Asian countries of Korea, China, and Japan will become visible from the end of this year to next year.
  • 30 Sep 2025 Primary endpoint (Percent change from baseline in seizure frequency (seizure rate per 28-day interval) of all simple partial motor, complex partial, or secondarily generalized seizures during the Maintenance Phase.)has been met as per SK Life Science media release

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