drugset / Trial / NCT06453213

Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

NCT06453213

Phase 4 Active not recruiting 49 enrolled SK Life Science, Inc.
NaSingle-groupOpen-labelTreatment

Summary

Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

Timeline

Start
2024-10-14
Primary completion
2027-05-26
Completion
2027-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Cenobamate Small molecule 100 mg
Subject Cenobamate Small molecule 200 mg

Indications