Abstracts

Long-Term Efficacy of Adjunctive Cenobamate: Open-Label Extension of a Randomized Clinical Study in a Multinational Asian Population

Abstract number : 3.352
Submission category : 7. Anti-seizure Medications / 7B. Clinical Trials
Year : 2025
Submission ID : 960
Source : www.aesnet.org
Presentation date : 12/8/2025 12:00:00 AM
Published date :

Authors :
Presenting Author: Louis Ferrari, RPh – SK Life Science, Paramus, New Jersey, USA

SangKun Lee, MD, PhD – Seoul National University
Peimin Yu, MD – Huashan Hospital, Fudan University
Eunyeong Choe, RN – SK Biopharmaceuticals Co., Ltd
Kyoung Heo, MD, PhD – Yonsei University College of Medicine
Seung Bong Hong, MD, PhD, ABCN – Epilepsy & Sleep Center, St. Peter’s General Hospital
Zhen Hong, MD – Huashan Hospital, Fudan University
Koji Iida, MD, PhD – Hiroshima University Hospital
Yong Heui Jeon, PhD – SK Biopharmaceuticals Co., Ltd
Jiwon Jung, RPh, PhD – SK Biopharmaceuticals Co., Ltd
Marc Kamin, MD – SK Life Science, Inc.
Kensuke Kawai, MD, PhD – Jichi Medical University
Ji Hyun Kim, MD, PhD – Korea University Guro Hospital, Korea University College of Medicine
Myung Won Kim, RPh – SK Biopharmaceuticals Co., Ltd
Xiaorong Liu, MD – Institute of Neuroscience, Second Affiliated Hospital of Guangzhou Medical University
Sunita N Misra, MD – SK Life Science, Inc.
Jungshin Park, RPh, PhD – SK Biopharmaceuticals Co., Ltd
William E. Rosenfeld, MD – Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA
Takamichi Yamamoto, MD, PhD – Seirei Mikatahara General Hospital
Dong Zhou, MD – West China Hospital of Sichuan University, Sichuan, China
Suiqiang Zhu, MD – Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Rationale: Results from a recent multicenter, randomized, double-blind (DB), placebo-controlled study (YKP3089C035 [C035]) in a multinational Asian population with uncontrolled focal seizures showed that adjunctive cenobamate (CNB) 100, 200, and 400 mg/day significantly reduced focal-onset seizure frequency in a dose-responsive manner. During the last 6 weeks of the 24-week study (DB maintenance phase) median percent reductions of 42.6%, 78.3%, and 100% were demonstrated for cenobamate 100, 200, and 400 mg/day, respectively (vs 25.9% placebo, all P< 0.001). Patients completing the entire 24-week DB treatment period were eligible to continue CNB in a 52-week open-label extension (OLE). Here we report interim efficacy and safety outcomes from the ongoing OLE.
Anti-seizure Medications