Evidence map›Paper›PMID 41428177›Full record

Trial reportAdvances in therapy2026

Efficacy and Safety of Adjunctive Cenobamate in Chinese Participants with Focal Seizure.

Peimin Yu, Xintong Wu, Li Cui, Songqing Pan, Yanbing Han, Huiqin Xu, Suiqiang Zhu, Xuefeng Wang, Huapin Huang, Tiancheng Wang and 19 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04557085 (A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04557085 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

TypeinterventionalSponsorSK Life Science, Inc.Ran2021 to 2025Enrolled519ConditionsPartial Seizure, Focal SeizureArmsCenobamate, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Peimin Yu *Department of Neurology, Huashan Hospital of Fudan University, Shanghai, 200040, China.
Xintong Wu *Department of Neurology, West China Hospital of Sichuan University, Chengdu, 610041, China.
Li CuiDepartment of Neurology, The First Hospital of Jilin University, Jilin, 130021, China.
Songqing PanDepartment of Neurology, Renmin Hospital of Wuhan University, Wuhan, 430060, China.
Yanbing HanDepartment of Neurology, The First Affiliated Hospital of Kunming Medical University, Kunming, 650032, China.
Huiqin XuDepartment of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325015, China.
Suiqiang ZhuDepartment of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Xuefeng WangDepartment of Neurology, First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.
Huapin HuangDepartment of Neurology, Fujian Medical University Union Hospital, Fuzhou, 350001, China.
Tiancheng WangEpilepsy Center, The Second Hospital and Clinical Medical School, Lanzhou University, Lanzhou, 730030, China.
Weiping LiaoInstitute of Neuroscience and Department of Neurology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510260, China.
Ming ZhangDepartment of Neurology, The Second Affiliated Hospital of Nanchang University, Nanchang, 330006, China.
Liou TangDepartment of Neurology, The Affiliated Hospital of Qingdao University, Qingdao, 266000, China.
Hongbin SunDepartment of Neurology, Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital, Chengdu, 610072, China.
Bing QinEpilepsy Center, Department of Neurosurgery, The First Affiliated Hospital of Jinan University, Guangzhou, 510630, China.
Zhiping HuDepartment of Neurology, The Second Xiangya Hospital of Central South University, Guangzhou, 510120, China.
Juan FengDepartment of Neurology, Shengjing Hospital of China Medical University, Shenyang, 110004, China.
Yangmei ChenDepartment of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Meiyun ZhangDepartment of Neurology, Tianjin Union Medical Center, The First Affiliated Hospital of Nankai University, Tianjin, 300121S, China.
Qifu LiDepartment of Neurology, The First Affiliated Hospital, Hainan Medical University, Haikou, 570102, China.
Xiong HanDepartment of Neurology, Henan Provincial People's Hospital, Zhengzhou University, Zhengzhou, 450003, China.
Bo XiaoDepartment of Neurology, Xiangya Hospital of Central South University, Changsha, 410031, China.
Huisheng ChenDepartment of Neurology, General Hospital of Northern Theater Command, Shenyang, 110160, China.
Luoqing LiDepartment of Neurology, Yueyang Central Hospital, Yueyang, 414000, China.
Yanran LiangDepartment of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, China.
Hui YeIgnis Therapeutics (Shanghai) Limited, Shanghai, 200000, China.
Yutong LiuIgnis Therapeutics (Shanghai) Limited, Shanghai, 200000, China.
Zhen Hong *Department of Neurology, Huashan Hospital of Fudan University, Shanghai, 200040, China. profzhong@sina.com.
Dong Zhou *Department of Neurology, West China Hospital of Sichuan University, Chengdu, 610041, China. zhoudong66@yahoo.de.ORCID 0000-0001-7101-4125

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe treatment landscape for focal seizures in China is distinct from those in other regions, with oxcarbazepine and sodium valproate being more commonly used than newer antiseizure medications (ASMs). Cenobamate, a novel ASM, has demonstrated significant efficacy in reducing seizure frequency. However, its efficacy and safety have not been assessed within the Chinese population.

methodsThe current study analyzed the 24-week double-blind period data of Chinese participants from a randomized, double-blind, placebo-controlled clinical trial (NCT04557085). Efficacy was assessed by determining seizure frequency reduction and responder rates across the cenobamate dose groups (100, 200, and 400 mg) and concomitant ASM groups. Safety was assessed by treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) during the double-blind treatment period.

resultsThis post hoc analysis included 227 participants with a median age of 32 (interquartile range 24-40) years with focal seizures across 24 sites in China. Cenobamate demonstrated a greater median percentage reduction in seizure frequency (100 mg, 39.5%, 200 mg, 88.0%, 400 mg, 100.0%) compared to placebo (24.6%). The responder rate of ≥ 50% was higher in the cenobamate groups (100 mg, 35.4%, 200 mg, 76.0%, 400 mg, 89.4%) compared to the placebo group (22.0%). A greater seizure reduction and responder rates were observed when cenobamate was administered alongside sodium channel blockers (SCBs) and non-SCBs, demonstrating better efficacy compared to placebo. On the basis of the number of baseline ASMs, cenobamate demonstrated seizure reduction and higher responder rates across all ASM groups as compared with placebo. Cenobamate demonstrated an acceptable safety profile across all dosage groups, with most AEs being mild to moderate. Common TEAEs reported included dizziness and somnolence.

conclusionCenobamate demonstrated a very favorable efficacy and safety profile in Chinese participants with focal seizures. The combination of cenobamate with both SCB and non-SCB treatments was effective in reducing seizure frequency and improved responder rates compared to placebo.

Indexed as

AnticonvulsantsCarbamatesChlorophenolsEpilepsies, PartialSeizuresTetrazolesAdultChinaDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationEast Asian PeopleFemaleHumansMaleTreatment OutcomeAnticonvulsantsCarbamatesCenobamateChlorophenolsTetrazolesCenobamateConcomitant therapyNon-sodium channel blockersSeizureSodium channel blockers

Identifiers

PMID41428177
PMCPMC12909318

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.