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

StatusActive, Not Recruiting
PhasePhase 4
Started2024-10-14
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 23 times since 2024-06-05; most recent filed 2026-08-25. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-08-25
Amendment Study Status v23
2026-07-20
Amendment Study Status v22
2026-02-26
Amendment Study Status, Contacts/Locations v21
2026-01-26
Amendment Study Status, Contacts/Locations v20
2025-12-17
Amendment Study Status, Contacts/Locations v19
2025-11-24
Amendment Study Status, Contacts/Locations v18
2025-10-27
Amendment Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v17
2025-09-24
Amendment Study Status, Contacts/Locations v16
2025-08-25
Amendment Study Status, Contacts/Locations v15
2025-07-23
Amendment Study Status, Contacts/Locations v14
2025-06-25
Amendment Study Status, Contacts/Locations v13
2025-05-22
Amendment Study Status, Contacts/Locations v12
2025-04-28
Amendment Study Status, Contacts/Locations v11
2025-03-25
Amendment Study Status, Eligibility, Contacts/Locations v10
2025-02-25
Amendment Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v9
2025-01-24
Amendment Study Status, Contacts/Locations v8
2024-12-20
Amendment Study Status, Contacts/Locations v7
2024-11-26
Amendment Study Status, Contacts/Locations v6
2024-10-25
Amendment Study Status, Contacts/Locations v5
2024-09-25
Amendment Study Status, Contacts/Locations v4
2024-08-26
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
2024-07-29
Amendment Study Status, Contacts/Locations v2
2024-06-25
Amendment Study Status, Contacts/Locations v1
2024-06-05
Original filing
Trial Details
NCT Number NCT06453213
Lead Sponsor SK Life Science, Inc.
Conditions Focal Onset Seizure
Enrollment 49 participants
Start Date 2024-10-14
Primary Completion 2027-05-26 (estimated)
Study Completion 2027-07-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-27