5 completed, 2 recruiting. 7 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 5, Recruiting 2 |
Follow Cenobamate: new trials by email Literature Review of Cenobamate trials Research Report on Cenobamate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds Cenobamate (tablet) for 12 to < 18 year olds, Cenobamate (syrup) for 2 to < 18 year olds - Partial Epilepsy | Phase 3 | Recruiting | Ono Pharmaceutical Co., Ltd. | 20 | 2026-06-10 | 2026-10-09 |
| ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures. Cenobamate - Epilepsy, Generalized | Phase 3 | Recruiting | Ono Pharmaceutical Co., Ltd. | 15 | 2022-07-12 | 2025-06-17 |
| Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures Xcopri - Partial Epilepsy | Phase 3 | Completed | SK Life Science, Inc. | 154 | 2022-01-10 | 2026-10-16 |
| Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS Cenobamate, Placebo - Partial Seizure, Focal Seizure | Phase 3 | Completed | SK Life Science, Inc. | 519 | 2021-03-08 | 2026-06-03 |
| Cenobamate Open-Label Extension Study for YKP3089C025 Cenobamate - Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy | Phase 3 | Completed | SK Life Science, Inc. | 147 | 2019-08-13 | 2026-06-26 |
| Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures Cenobamate, Placebo - Primary Generalized Epilepsy | Phase 3 | Completed | SK Life Science, Inc. | 169 | 2018-10-03 | 2026-07-02 |
| Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures YKP3089 - Partial Epilepsy | Phase 3 | Completed | SK Life Science, Inc. | 1345 | 2016-08-03 | 2024-05-14 |
Epilepsies, Partial (3) · Seizures (3) · Epilepsy, Idiopathic Generalized (2) · Epilepsy, Generalized (1)
SK Life Science, Inc. (5) · Ono Pharmaceutical Co., Ltd. (2)
Hungary (4) · Poland (4) · South Korea (4) · United States (4) · Australia (3) · Bulgaria (3) · Czechia (3) · Germany (3) · Japan (3) · Spain (3) · Ukraine (3) · Slovakia (2) · Argentina (1) · Chile (1) · China (1)
Sunita Misra, MD (3) · Project Leader (2) · Marc Kamin, MD (1)
PMID 34633084, PMID 35605481, PMID 38446341, PMID 39087564, PMID 41101116, PMID 41428177