Evidence map›Paper›PMID 32409485›Full record

Trial reportNeurology2020

Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures.

Steve S Chung, Jacqueline A French, Jacek Kowalski, Gregory L Krauss, Sang Kun Lee, Maciej Maciejowski, William E Rosenfeld, Michael R Sperling, Sarah Mizne, Marc Kamin

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01397968 (A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures), which is not on this map. Cited by 115 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 5 pooled it
16.4field-weighted citation impact, top 1% of its field
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.

NCT01397968 phase2completednot on this map

A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

TypeinterventionalSponsorSK Life Science, Inc.Ran2011 to 2021Enrolled222ConditionsPartial EpilepsyArmsYKP3089, Placebo
3 · Its place in the literature

Who cites it

115 citing papers in PubMed, 5 syntheses or guidelines pooled it, 227 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Cenobamate add-on therapy for drug-resistant focal epilepsy.The Cochrane database of systematic reviews · 2024
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
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  13. Article
  14. Review
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  16. Review
  17. Cenobamate: An Appraisal Five Years On.Neurology and therapy · 2026
    Review
  18. Observational
  19. Review
  20. Article

55 more citing papers are in PubMed but not listed here.

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

10 authors at 3 institutions in 2 countries.

Steve S ChungFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ. steve.chung@bannerhealth.com.
Jacqueline A FrenchFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.
Jacek KowalskiFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.
Gregory L KraussFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.
Sang Kun LeeFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.
Maciej MaciejowskiFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.
William E RosenfeldFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.
Michael R SperlingFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.
Sarah MizneFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.
Marc KaminFrom the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.
NZOZ Medi-Spatz · PLCenter for Children · USThomas Jefferson University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of adjunctive cenobamate 200 mg/d in patients with uncontrolled focal (partial-onset) seizures despite treatment with 1 to 3 antiepileptic drugs.

methodsIn this multicenter, double-blind, placebo-controlled study, adults 18 to 65 years of age with focal seizures were randomized 1:1 (cenobamate:placebo) after an 8-week baseline period. The 12-week double-blind treatment period consisted of a 6-week titration phase and a 6-week maintenance phase. The primary outcome was percent change in seizure frequency (from baseline) per 28 days during double-blind treatment.

resultsTwo hundred twenty-two patients were randomized; 113 received cenobamate and 109 received placebo; and 90.3% and 90.8% of patients, respectively, completed double-blind treatment. Median baseline seizure frequency was 6.5 in 28 days (range 0-237). Compared to placebo, cenobamate conferred a greater median percent seizure reduction (55.6% vs 21.5%;

conclusionAdjunctive treatment with cenobamate 200 mg/d significantly improved seizure control in adults with uncontrolled focal seizures and was well tolerated. CLINICALTRIALSGOV IDENTIFIER: NCT01397968. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that, for patients with uncontrolled focal seizures, adjunctive cenobamate reduces seizures.

Indexed as

AdolescentAdultAnticonvulsantsCarbamatesChlorophenolsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedSeizuresTetrazolesYoung AdultAnticonvulsantsCarbamatesCenobamateChlorophenolsTetrazoles

Identifiers

PMID32409485
PMCPMC7357293
OpenAlexW3025691036

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.