drugset / Trial / NCT01397968
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.
Timeline
- Start
- 2011-07-06
- Primary completion
- 2013-06
- Completion
- 2021-01-28
Outcome
Met primary endpoint
registry MEDIAN YKP3089: 55.6 (-417.3 to 100.0) percent seizure reduction NCT01397968 ↗
registry analysis (superiority test); YKP3089 vs Placebo; p <0.0001; Wilcoxon rank sum NCT01397968 ↗
Publications
- French JA, Chung SS, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Kamin M. Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: Open-label extension of a randomized clinical study. Epilepsia. 2021 Sep;62(9):2142-2150. doi: 10.1111/epi.17007. Epub 2021 Jul 13.
- Chung SS, French JA, Kowalski J, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Mizne S, Kamin M. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020 Jun 2;94(22):e2311-e2322. doi: 10.1212/WNL.0000000000009530. Epub 2020 May 14.
- Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: a summary of the Eleventh Eilat Conference (EILAT XI). Epilepsy Res. 2013 Jan;103(1):2-30. doi: 10.1016/j.eplepsyres.2012.10.001. Epub 2012 Dec 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cenobamate | Small molecule | 200 mg | — |