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New epilepsy drug candidate aims to tame severe seizures

NCT ID NCT03678753

Disease control Sponsor: SK Life Science, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether cenobamate, an experimental anti-epileptic drug, can safely reduce primary generalized tonic-clonic (PGTC) seizures when added to a person's usual seizure medications. Adults and adolescents aged 12 and older with PGTC seizures are randomly assigned to receive either cenobamate or a placebo, with doses gradually increased over 22 weeks. Participants track their seizures in a diary, and those who complete the study may join a longer-term extension trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cenobamate
What this could lead to
If successful, cenobamate could become a new add-on treatment option for people with hard-to-control generalized tonic-clonic seizures.
What could go wrong
This is a mid-stage trial with only 169 participants. The drug may not prove more effective than placebo, and side effects could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

169 people

The number who actually took part.

Started

Oct 2018

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is male or female and aged ≥12 years. 2. Written informed consent signed by the subject or legal guardian, or legally authorized representative (LAR), prior to entering the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. Age- appropriate assent will be obtained for adolescents. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the Informed Consent Form (ICF) in accordance with ICH guidelines. 3. Female subjects of childbearing potential are willing to use an acceptable form of birth control 4. Subject has a clinical diagnosis of PGTC seizures (with or without other subtypes of generalized seizures) in the setting of idiopathic generalized epilepsy. 5. Subject experiences at least 5 PGTC seizures in 12 weeks during the Pre-Randomization Period. 6. Subject has had a routine electroencephalogram (EEG) within 5 years prior to Visit1 (Screening/Baseline) or during the Pre-Randomization Period with electroencephalographic features consistent with idiopathic generalized epilepsy; other concomitant anomalies must be explained by adequate past medical history. 7. Subject has undergone computed tomography (CT) or magnetic resonance imaging (MRI) within 10 years prior to Visit 1 (Screening/Baseline) or during the Pre-Randomization Period that ruled out a progressive cause of epilepsy. 8. Subject is currently receiving 1 to a maximum of 3 concomitant AEDs with fixed dosing regimens for a minimum of 30 days prior to Visit 1 (Screening/Baseline). 1. Benzodiazepines (except diazepam, see Exclusion Criterion No.7) taken at least once per week during the 30 days prior to Visit 1 (Screening/Baseline) for epilepsy, anxiety, or sleep disorder will be counted as 1 AED and the dosage must be continued unchanged throughout the study. Therefore, only a maximum of 2 additional approved AEDs will be allowed. (See Exclusion Criterion No. 10 for intermittent benzodiazepine rescue parameters.) 2. Subjects receiving felbamate as a concomitant AED must meet the following criteria: i. Have a 2-year history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 (Screening/Baseline). ii. No prior or known history of hepatotoxicity or hematologic disorder due to felbamate. 9. Subject with an implanted vagal nerve or deep brain stimulator will be allowed if the stimulator was implanted at least 5 months prior to Visit 1 (Screening/Baseline) and the stimulator parameters are not changed for 30 days prior to Visit 1 and for the duration of the study. 10. Subject taking a ketogenic diet will be allowed as long as the diet has been stable for at least 3 months prior to Visit 1 (Screening/Baseline) and will remain stable for the duration of the study. Exclusion Criteria: 1. Female subjects who are pregnant (or planning to become pregnant during the study), lactating, or breast-feeding. 2. Subject has a history o f status epilepticus that required hospitalization within 12 months prior to Visit 1 (Screening/Baseline). 3. Subject has PGTC seizure clusters where individual seizures cannot be counted or classified. 4. Subject has a history of non-epileptic psychogenic seizures. 5. Subject has a concomitant diagnosis of Partial Onset Seizures (POS). 6. Subject has a clinical diagnosis of Lennox-Gastaut syndrome. 7. Subject is currently taking (within the 30 days prior to Visit 1 \[Screening/Baseline\]) any of the following medications: diazepam (for any reason other than as intermittent benzodiazepine rescue medication), phenytoin, mephenytoin, fosphenytoin, phenobarbital, primidone, ethotoin, clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, or efavirenz. 8. Subject has participated in previous cenobamate clinical studies. 9. Subject has a history of vigabatrin use within 5months prior to Visit 1 (Screening/Baseline), or the subject plans to begin treatment with vigabatrin during the study. a) A subject with a history of vigabatrin use that ended more than 5 months prior to Visit1 may be enrolled after documented evidence of no vigabatrin-associated clinically significant abnormality in an automated visual perimetry test. 10. Subject has a history of intermittent use of rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period is considered a 1-time rescue) 4 or more times within the 30 days prior to Visit 1 (Screening/Baseline). 11. Subject has received an investigational drug or device within 30 days prior to Visit 1 (Screening/Baseline). 12. Subject has a history of drug or alcohol dependency or abuse within 2 years prior to Visit 1 (Screening/Baseline). 13. Subject tests positive, via urine drug screen at Visit 1 (Screening/Baseline), for illicit drugs not legalized in your region/state, or for a drug that has not been prescribed (e.g., certain opiates). 14. Subject has a history of any serious drug-induced hypersensitivity reaction (including, but not limited to, Stevens Johnson syndrome, toxic epidermal necrolysis, or DRESS) or any drug-related rash requiring hospitalization. 15. History of AED-associated rash that involved conjunctiva or mucosae. 16. History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication. 17. Subject has evidence of clinically significant abnormalities or disease (e.g., psychiatric, cardiac, respiratory, gastrointestinal, hepatic \[aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal (ULN), or total or direct bilirubin not more than ULN\], or renal disease) that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study. 18. Presence of congenital short QT syndrome or relevant replicated change in QT/QTc interval less than 340 msec on ECG. 19. Subject has any significant active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results. 20. Subject has a creatinine clearance less than 50 mL/min, as calculated by Cockcroft-Gault equation. 21. Subject has an absolute neutrophil count less than 1500/µL. 22. Subject has platelet count lower than 80,000/µL in subjects treated with valproate. 23. Subject has a history of positive antibody/antigen test for hepatitis A, hepatitis B, hepatitis C, or HIV. 24. Subject has any suicidal ideation (with intent with or without a plan) at Visit 1 (Screening/Baseline) or Visit 4 (Randomization) (i.e., answering YES to Question 4 and/or Question 5 on the Suicidal Ideation section of the C-SSRS). 25. Subject has more than 1 lifetime suicide attempt. 26. Subject is a staff member or immediate family member of study staff. 27. Previous exposure to cenobamate or sensitivity/allergy to components of the oral suspension. Any potential exception to the inclusion as well as exclusion criteria allowing de minimis (clinically trivial and meaningless) variations must be approved by the Medical Monitor.

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Conditions

The condition(s) this trial relates to.

epilepsy with generalized tonic-clonic seizures idiopathic generalized epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary generalized epilepsy

Contacts and locations

Locations

  • ANRC Research

    El Paso, Texas, 79912, United States

  • Acibadem City Clinic MHAT Tokuda EAD

    Sofia, Sofia, 1407, Bulgaria

  • Ajou University Hospital

    Suwon, South Korea

  • Austin Health

    Heidelberg, 3084, Australia

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Brainstorm Research

    Miami, Florida, 33176, United States

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, South Korea

  • Carilion Clinic

    Roanoke, Virginia, 24016, United States

  • Center for Neurosciences

    Tuscon, Arizona, 85718, United States

  • Centrum Leczenia Padaczki i Migreny

    Krakow, Lesser Poland Voivodeship, 31-209, Poland

  • Centrum Medyczne Oporów

    Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

  • Centrum Medyczne Plejady

    Krakow, Lesser Poland Voivodeship, Poland

  • Centrum Medyczne Pratia Katowice

    Katowice, Silesian Voivodeship, 40-081, Poland

  • Centrum Medyczne Warszawa Pratia s.a

    Warsaw, Masovian Voivodeship, 01-868, Poland

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.

    Ksawerów, Iodzkie, 95-054, Poland

  • Cerebovaskularni poradna s.r.o.

    Ostrava-Vitkovice, 703 00, Czechia

  • Cerebrovaskularni poradna, s.r.o.

    Ostrava-Poruba, 708 52, Czechia

  • Charite - Universitätsmedizin Berlin - Sozialpädiatrisches Zentrum

    Berlin, 13353, Germany

  • Child Neurology Consultants of Austin

    Austin, Texas, 78757, United States

  • Children's Health Queensland Hospital

    South Brisbane, 4101, Australia

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30329, United States

  • Children's Hospital of Colorado

    Grand Junction, Colorado, 80045, United States

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, South Korea

  • Clinical Integrative Research Center of Atlanta, CIRCA

    Atlanta, Georgia, 30328, United States

  • Clinical Research Center Spolka z Ograniczona Odpowiedzialnoscia Medic-R sp. k

    Poznan, Greater Poland Voivodeship, 60-848, Poland

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907, United States

  • Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council

    Dnipropetrovsk, Dnipropetrovsk Oblast, 49005, Ukraine

  • Communal Enterprise Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov of Dnipropetrovsk Regional Council, Regional Center of Psychosomatic Disorders based on Psychoneurology Department

    Dnipro, Dnipro, 49005, Ukraine

  • Communal Enterprise Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev of Poltava Regional Council

    Poltava, 36000, Ukraine

  • Communal Enterprise Regional Medical Center of Family Health of the Dnipropetrovsk Regional Council

    Dnipro, 49000, Ukraine

  • Communal Non-Commercial Enterprise of Kharkiv Regional Council Regional Clinical Psychiatric Hospital #3

    Kharkiv, Kharkiv Oblast, 61068, Ukraine

  • Communal Non-Profit Enterprise Odesa Regional Medical Centre of Mental Health Odesa Regional Council, Department #2

    Odesa, Odesa Oblast, 67513, Ukraine

  • Communal Non-Profit Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Neurological Department, Antiepileptic Center

    Lviv, Lviv Oblast, 79010, Ukraine

  • Communal Non-commercial Enterprise City Children's Clinical Hospital 6 of Dnipro City Council

    Dnipro, 49009, Ukraine

  • Consultants in Epilepsy and Neurology

    Boise, Idaho, 83702, United States

  • Csongrád Megyei Egészségügyi Elláto Központ Ideggyógyászati Osztály

    Hódmezővásárhely, 6800, Hungary

  • Debreceni Egyetem Klinikai Központ, Gyermekgyógyászati Intézet Nagyerdei krt. 98

    Debrecen, Hungary

  • Diagnostic Consultative Center Equita EOOD

    Varna, Varna, 9000, Bulgaria

  • Diagnostic Consultative Center Neoclinic EAD

    Sofia, Sofia, 1408, Bulgaria

  • Duke University Children's Health Center

    Durham, North Carolina, 27710, United States

  • Fakultni nemocnice u sv. Anny v Brne, 1. Neurologicka klinika

    Brno, 656 91, Czechia

  • Fakultní nemocnice v Motole

    Prague, Prague, 150 06, Czechia

  • Five Towns Neuroscience Research

    Woodmere, New York, 11598, United States

  • Florida Hospital Medical Group

    Orlando, Florida, 32803, United States

  • Forbeli s.r.o., Neurologicka ordinace

    Prague, 160 00, Czechia

  • Gornoslaskie Centrum Medyczne - Samodzielny Publiczny Szpital Kliniczny Number 7

    Katowice, Silesian Voivodeship, 40-635, Poland

  • Gyncentrum Clinic Sp. z.o.o

    Katowice, Silesian Voivodeship, 40-851, Poland

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96814, United States

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29011, Spain

  • Hospital Universitario La Fe

    Valencia, 46026, Spain

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • IN MEDIC s.r.o

    Bardejov, 085 01, Slovakia

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Institute of Neurology and Neuropsychology LTD

    Tbilisi, 0186, Georgia

  • Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie

    Lublin, Lublin Voivodeship, 20-090, Poland

  • JFK Medical Center- The Neuroscience Institute

    Edison, New Jersey, 08818, United States

  • Konzílium, s.r.o

    Dubnica nad Váhom, Trenčín Region, 018 41, Slovakia

  • Kyiv City Psychoneurological Hospital №2

    Kiev, Kyiv Oblast, 02192, Ukraine

  • LEPL Tbilisi State Medical University Givi Zhvania Academic Clinic of Pediatry

    Tbilisi, 0159, Georgia

  • LeBonheur Children's Medical Center

    Memphis, Tennessee, 38105, United States

  • M.A. LEK A.M. Maciejowscy S.C Centrum Terapii SM

    Katowice, Silesian Voivodeship, 40-571, Poland

  • MEDBAJ, s.r.o., Neurologicka ambulancia, Nemocnicna 1944/10

    Dolný Kubín, 026 01, Slovakia

  • MHAT Lyulin EAD

    Sofia, Sofia, 1336, Bulgaria

  • MHAT Sv. Ivan Rilski Gorna Oryahovitsa EOOD

    Gorna Oryahovitsa, Veliko Tarnovo, 5100, Bulgaria

  • MUDr. Beata Dupejova, neurologická ambulncia, s.r.o

    Banská Bystrica, 974 04, Slovakia

  • Maine Medical Center

    Scarborough, Maine, 04074, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Medical Center Medica Plus OOD

    Veliko Tarnovo, Veliko Tarnovo, 5000, Bulgaria

  • Michigan State University

    East Lansing, Michigan, 48824, United States

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817, United States

  • Minneapolis Clinic of Neurology Golden Valley

    Golden Valley, Minnesota, 55422, United States

  • MultiCare Institute for Research and Innovation

    Spokane, Washington, 99204, United States

  • Multiprofile Hospital for Active Treatment Puls AD

    Blagoevgrad, Blagoevgrad, 2700, Bulgaria

  • Municipal Non-Profit Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Department of Cerebro-Vascular Diseases with Neurosurgery

    Odesa, Odesa Oblast, 65025, Ukraine

  • Municipal Non-Profit Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Neurology #2

    Ternopil, 46020, Ukraine

  • Municipal Non-Profit Enterprise Zaporizhzhia Regional Clinical Hospital Of Zaporizhzhia Regional Council

    Zaporizhzhya, Zaporizhzhya, 69600, Ukraine

  • Municipal Non-profit Enterprise City Clinical Hospital No.16 of Dnipro City Council, Department of Neurology

    Dnipro, Dnipropetrovsk Oblast, 49069, Ukraine

  • Municipal Non-profit Enterprise Prykarpattia Regional Clinical Center for Mental Health of Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76011, Ukraine

  • Municipal Non-profit Enterprise Regional Clinical Center of Neurosurgery and Neurology of Zakarpattia Regional Council, Department of Neurosurgery #2

    Uzhhorod, Zakarpattia Oblast, 88018, Ukraine

  • Municipal Non-profit Enterprise Vinnytsia Regional Clinical Psychoneurological Hospital named after Acad. O.I. Yushchenko of Vinnytsia Regional Council, Department of Neurology #3

    Vinnytsia, Vinnytsya, 21005, Ukraine

  • NEURES, s.r.o.-Neurologická Ambulancia

    Krompachy, 053 42, Slovakia

  • NZOZ Poradnia Zdrowia Psychicznego Antonijczuk Boleslaw

    Tyniec Mały, Lower Silesian Voivodeship, 55-040, Poland

  • Narodny Ustav Detskych Chorob

    Bratislava, Slovakia

  • Nestatni zdravotnicke zarizeni, privatni ordinance neurologie

    Hradec Králové, 500 03, Czechia

  • Neuro Pain Medical Center

    Fresno, California, 93710, United States

  • Neurologicka ambulance MUDr.Monika Zahumenska

    Zlín, 760 01, Czechia

  • New York Presbyterian Hospital

    Brooklyn, New York, 11215, United States

  • Niepubliczny Zaklad Opieki Zdrowotnej Novo-Med

    Katowice, Silesian Voivodeship, 40-650, Poland

  • Niepubliczny Zakład Opieki Zdrowotnej - Centrum Neurologii Dziecięcej i Leczenia Padaczki

    Kielce, Świętokrzyskie Voivodeship, Poland

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601, United States

  • Odessa Regional Psychiatric Hospital No. 2,

    Odesa, 67513, Ukraine

  • Ohio Health Research and Innovation Institute

    Columbus, Ohio, 43214, United States

  • PMG Research of McFarland Clinic

    Ames, Iowa, 50010, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Rush University

    Chicago, Illinois, 60612, United States

  • SMG-SNU Boramae Medical Center

    Seoul, Gyeonggi-do, South Korea

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901, United States

  • Semmelweis Egyetem

    Budapest, Budapest, 1083, Hungary

  • Sächsisches Epilepsiezentrum Kleinwachau gGmbH

    Radeberg, 01454, Germany

  • Temple University Lewis Katz School of Medicine

    Philadelphia, Pennsylvania, 19140, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UBMD Neurology

    Buffalo, New York, 14203, United States

  • UMHAT Kanev AD

    Rousse, Ruse, 7002, Bulgaria

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Missouri Health Care

    Columbia, Missouri, 65201, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Toledo

    Toledo, Ohio, 43606, United States

  • University of Utah / Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Universitätsklinikum Jena

    Jena, Germany

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105, Germany

  • Valley Medical Center

    Renton, Washington, 98057, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Vestra Clinics, s.r.o.

    Rychnov nad Kněžnou, 516 01, Czechia

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, Warmian-Masurian Voivodeship, 10-561, Poland

  • Wojewódzki Specjalistyczny Szpital Dziecięcy im. sw. Ludwika sw Krakowie

    Krakow, Lesser Poland Voivodeship, Poland

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