Table 4.
Clinical trials with cenobamate (YKP3089) registered in the ClinicalTrials.gov database.
| Identifier | Study Start to Completion | Condition | Intervention | N Enrolled | Comment |
|---|---|---|---|---|---|
| NCT04513860 | NA | Focal epilepsy | CNB | NA | The objective of this expanded access program is to continue providing treatment with CNB to patients with focal epilepsy that were enrolled in the SK Life Science Inc clinical trials |
| NCT00616148 | Aug 2007–Jan 2010 | Focal epilepsy | CNB, placebo | 11 | PPR study |
| NCT01397968 | Jul 2011–Jan 2021 | Focal epilepsy | CNB, placebo | 222 | Efficacy of CNB in DRE |
| NCT01866111 | Jul 2013–Oct 2021 | Focal epilepsy | CNB, placebo | 437 | Effective dose range of CNB as adjunctive therapy |
| NCT02535091 | Aug 2016–Feb 2022 | Focal epilepsy | CNB | 1345 | Effective dose range of CNB as adjunctive therapy |
| NCT03234699 | Feb 2017–Jul 2017 | Healthy | CNB, midazolam, warfarin, omeprazole, bupropion | 24 | Investigate the influence of CNB on the activity of CYP3A4/5, CYP2B6, CYP2C19, and CYP2C9 |
| NCT03509285 | Mar 2017–Dec 2017 | Healthy | CNB, alprazolam | 53 | Evaluate the abuse liability potential of CNB in recreational drug users with sedative drug use experience |
| NCT03678753 | Sep 2018–Jul 2024 | Primary generalized epilepsy | CNB, placebo | 170 | Safety and effectiveness of CNB on primary generalized tonic-clonic seizures |
| NCT03961568 | Aug 2019–May 2023 | Primary generalized epilepsy | CNB | 130 | Long-term safety of CNB adjunctive therapy in subjects with primary generalized tonic-clonic seizures |
| NCT04879433 | Jun 2020–Nov 2023 | Focal epilepsy | CNB | 100 | Efficacy, safety, and tolerability of CNB as adjunctive treatment of DRE |
| NCT04690751 | Dec 2020–May 2021 | Healthy | CNB | 28 | Pharmacokinetics of CNB |
| NCT04557085 | Mar 2021–Oct 2024 | Focal epilepsy | CNB, placebo | 540 | Efficacy and safety of 100, 200, and 400 mg/day of CNB as adjunctive therapy in focal epilepsy |
| NCT04903314 | May 2021–Oct 2024 | Focal epilepsy | CNB | 24 | Pharmacokinetics of CNB in pediatric subjects |
| NCT04791553 | Jun 2021–Nov 2022 | NA | CNB | 16 | Effect of severe hepatic impairment on the pharmacokinetics of CNB |
| NCT05067634 | Jan 2022–Jul 2026 | Focal epilepsy | CNB | 140 | Safety and tolerability of CNB in pediatric subjects with focal epilepsy |
| NCT05572255 | Sep 2022–Jan 2023 | Healthy | CNB | 24 | Pharmacokinetics of CNB |
| NCT05859854 | Jan 2023–Sep 2024 | Focal epilepsy | CNB | 200 | Efficacy of CNB in DRE |
| NCT05747001 | Jan 2023–Apr 2023 | Focal epilepsy | CNB | 500 | Effectiveness and tolerability of CNB from real-world data collected in patients who participated in the early access program |
Abbreviations: CNB: cenobamate; CYP: cytochromes P450; DRE: drug-resistant epilepsy; PPR: photoparoxismal-electroencephalogram response (PPR) model.