Abstract Details

Title Long-term Efficacy of Adjunctive Cenobamate: Open-label Extension of a Randomized Clinical Study in a Multinational Asian Population

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P11 - Poster Session 11 (11:45 AM-12:45 PM)

Poster/Presentation
Number 10-005

Objective To report interim efficacy and safety from the YKP3089C035 (C035) open-label extension (OLE) study.

Background Results from the multicenter, randomized, double-blind, placebo-controlled C035 study in a multinational Asian population with uncontrolled focal seizures showed that adjunctive cenobamate 100, 200, and 400 mg/day significantly reduced focal-onset seizure frequency in a dose-responsive manner.

Design/Methods In C035, adults 18-70 years old with ≥8 focal seizures during an 8-week baseline despite treatment with 1-3 antiseizure medications were randomized 1:1:1:1 to placebo or cenobamate 100, 200, or 400 mg/day. Patients entering the OLE underwent an 18-week blinded conversion to cenobamate target dose of 400 mg/day. Then to maintain blinding, all patients entered the 32-week OLE maintenance phase starting at cenobamate 300 mg/day (doses could be adjusted from 50-400 mg/day). Percent change from double-blind baseline in 28-day focal seizure frequency and responder rates were assessed in the OLE maintenance phase efficacy population (OLE-EM, ≥1 dose of study drug and any seizure data during OLE maintenance phase). Safety was also assessed.

Results This OLE interim analysis included 231 patients (mean age 35.7 years; 50.6% male). Of these, 184 were included in the OLE-EM population (136 originally randomized to cenobamate; 48 transitioned from placebo). Median percent reductions of 76.8%, 84.5%, 90.6%, and 85.1% were demonstrated for patients originally randomized to placebo and cenobamate 100, 200, and 400 mg/day, respectively. Responder rates of ≥50% and 100% by original randomization group were: 67% and 17% for placebo; 71% and 25% for cenobamate 100 mg/day; 76% and 24% for cenobamate 200 mg/day; and 69% and 36% for cenobamate 400 mg/day. TEAEs reported in ≥20% of patients were dizziness, somnolence, and COVID-19 infection. Serious TEAEs occurred in 10% (23/231) of patients.

Conclusions Reductions in seizure frequency increased or were maintained during the 32-week OLE maintenance phase. The safety profile was generally consistent with the double-blind phase.

Authors/Disclosures
Louis Ferrari (SK Lifescience) PRESENTER	Louis Ferrari has received personal compensation for serving as an employee of SK Life science.
Sang Kun Lee, MD (Seoul national University Hospital)	Prof. Lee has nothing to disclose.
Peimin Yu	Dr. Yu has nothing to disclose.
Eunyeong Choe, RN	Ms. Choe has nothing to disclose.
Kyoung Heo, MD, PhD	Dr. Heo has nothing to disclose.
Yu Hong, Master of Science	Mr. Hong has received personal compensation for serving as an employee of Genesis Research Group.
Zhen Hong	Prof. Hong has nothing to disclose.
Koji I. Iida, MD, PhD	Prof. Iida has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. Prof. Iida has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Daiich-Sankyo. Prof. Iida has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for UCB Japan. Prof. Iida has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. The institution of Prof. Iida has received research support from Ricoh. The institution of Prof. Iida has received research support from UCB Japan. The institution of Prof. Iida has received research support from Zimmer Biomet.
Yong Heui Jeon, PhD	Dr. Jeon has received personal compensation for serving as an employee of SK biopharmaceuticals.
Jiwon Jung, PhD	Dr. Jung has nothing to disclose.
Marc Kamin, MD	Dr. Kamin has received personal compensation for serving as an employee of SK LIFE SCIENCE INC.
Kensuke Kawai, MD, PhD	Prof. Kawai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SK Biopharma. Prof. Kawai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Japan. Prof. Kawai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zimmer Biomet. Prof. Kawai has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EP Medical. Prof. Kawai has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eisai. Prof. Kawai has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Daiichi-Sankyo.
Ji Hyun Kim, MD, PhD	Prof. Kim has nothing to disclose.
YI-HSUAN LIU, PhD	Dr. LIU has nothing to disclose.
Sunita N. Misra, MD (SK Life Science)	Dr. Misra has received personal compensation for serving as an employee of SK Life Science, Inc. An immediate family member of Dr. Misra has received personal compensation for serving as an employee of Neurocrine Biosciences.
Jungshin Park, PhD	Dr. Park has received personal compensation for serving as an employee of SK Biopharmaceuticals.
William E. Rosenfeld, MD, FAAN (Comprehensive Epilepsy Care Center for Children and Adults)	The institution of Dr. Rosenfeld has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for SK Life Science. Dr. Rosenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for SK Life Science.
Takamichi Yamamoto, MD, PhD, FAES (Seirei Mikatahara General Hospital)	Dr. Yamamoto has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. Dr. Yamamoto has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Daiichi-Sankyo.
Dong Zhou	Dong Zhou has nothing to disclose.
SUIQIANG ZHU	No disclosure on file

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