New epilepsy drug candidate aims to tame severe seizures

NCT ID NCT03678753

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

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for PRIMARY GENERALIZED TONIC-CLONIC SEIZURES are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.

Contacts and locations

Show contact details

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