New hope for kids with focal seizures: cenobamate trial underway

NCT ID NCT05067634

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

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This phase 3 trial is testing the safety and tolerability of the drug cenobamate (Xcopri) in 140 children aged 2 to 17 with partial-onset (focal) seizures. Researchers will monitor side effects, lab results, and drug levels in the blood. The study is open-label, meaning everyone knows they are receiving the drug, and it is currently active but not recruiting.

What this could mean

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

Active substance: cenobamate (Xcopri)
What this could lead to: If successful, this could provide a new treatment option to help control focal seizures in children, potentially reducing seizure frequency.
What could go wrong: This is an open-label study without a placebo group, so results may be less definitive. Side effects are possible, and the drug may not work for all children.

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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

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

2 to 18 years

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. Have a diagnosis of epilepsy with partial-onset (focal) seizures (POS) with or without secondarily generalized seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures. A diagnosis should have been established at least 12 months prior to Visit 1 (Screening) by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e., clinical history) 2. Male or female participant, from age 2 to less than 18 years at the time of informed consent/assent (dates including informed consent in YKP3089C039) 3. Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds \[lb\]) 4. Have had a brain imaging (e.g., magnetic resonance imaging \[MRI\] scan or computed tomography (CT) within 10 years before Visit 1 (Screening) that ruled out a progressive cause of epilepsy. 5. For subjects new to Study YKP3089C040, participants must have had at least 1 POS seizure during the 28-day Baseline Period. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS 6. Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1 (Screening). A vagal nerve stimulator \[VNS\] will not be counted as one of the 3 allowed AEDs but the settings should be stable for at least 4 weeks prior to Visit 1 (Screening). 7. Investigator believes subject could benefit from new or continued exposure to study drug 8. Subjects entering from study YKP3089C039 must continue to meet all of the inclusion criteria from the YKP3089C039 study 9. Subjects receiving felbamate as a concomitant AED must meet the following criteria: 1. Have a 12-month history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 (Screening). 2. No prior or known history of hepatotoxicity or hematologic disorder due to felbamate. 10. Subjects following a ketogenic diet will be allowed as long as the diet has been stable for at least 30 days prior to Visit 1 (Screening) and will remain stable for the duration of the study Exclusion Criteria: 1. Females who are breastfeeding or pregnant at Screening or Baseline. 2. Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 2 years before Visit 1 (Screening). 3. Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1 (Screening). 4. Have an unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified tests (e.g., significant suicide risk, including suicidal behavior and ideation within 6 months before Visit 1 (Screening), current psychotic disorder, acute mania). 5. Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 \[i.e., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) in participants aged 6 and above, if able\]. 6. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1 (Screening); however, those who have previously documented "failed" epilepsy surgery will be allowed. 7. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments. 8. Presence of only nonmotor simple partial seizures or primary generalized epilepsies. 9. Evidence of moderate or severe renal insufficiency as defined by estimated glomerular filtration rates (eGFRs) of 31 to \< 60 "milliliters per minute (mL/min)" and \< 30 mL/min, respectively. 10. Evidence of significant active hepatic disease. Stable elevation of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) due to concomitant medication(s), will be allowed if they are less than 3 times the upper limit of normal (ULN). 11. Evidence of significant active hematological disease; white blood cell (WBC) count equal or less than 2500/µL (2.50 1E+09/liter \[L\]) or an absolute neutrophil count equal or less than 1000/µL (1.00 1E+09/L). 12. Subjects with Familial short QT syndrome. 13. Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than 450 milliseconds (msec) or shortened corrected QT interval (QTc) defined as less than 340 msec. 14. Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors. 15. 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. 16. History of AED-associated rash that involved conjunctiva or mucosae. 17. History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication. 18. Concomitant use of vigabatrin. Participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 (Screening) and with documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in a visual perimetry test. 19. 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) more than once within the 30 days prior to Visit 1(Screening). 20. A VNS implanted less than 5 months before Visit 1 (Screening) or changes in parameter less than 4 weeks before Visit 1 (or thereafter during the study). 21. History of or a concomitant medical condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study or compromise the participant's ability to safely complete the study. 22. Have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1 (Screening), or within approximately 5 half-lives of the previous investigational compound, whichever is longer. 23. Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 24. For subjects new to Study YKP3089C040 previous exposure to cenobamate or sensitivity/allergy to components of the oral suspension.

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Conditions

The condition(s) this trial relates to.

focal epilepsy visual epilepsy

As listed by the trial registrant

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

Partial epilepsy

Contacts and locations

Locations

Ajou University Hospital

Suwon, South Korea
Bethesda Gyermekkorhaz

Budapest, Hungary
Boston Children's Health Physicians - Neurology at Hawthorne

Hawthorne, New York, 10532, United States
Centrum Medyczne Plejady

Krakow, Poland
Charite University Hospital

Berlin, Germany
Child Neurology Consultants of Austin

Austin, Texas, 78731, United States
Children's Health Queensland Hospital and Health Service

South Brisbane, Australia
Chungbuk National University Hospital

Cheonju, South Korea
Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States
Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States
Clinical Integrative Research Center of Atlanta

Sandy Springs, Georgia, 30328, United States
Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States
Duke University Hospital

Durham, North Carolina, 27710, United States
Hospital Infantil Universitario Niño Jesús

Madrid, Spain
Hospital Sant Joan de Déu Barcelona

Barcelona, Spain
Hospital Universitari Vall d'Hebrón

Barcelona, Spain
Hospital Universitario Virgen del Rocío

Seville, Spain
Korea University Guro Hospital

Seoul, South Korea
Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States
Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States
Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States
Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States
Niepubliczny Zaklad Opieki Zdrowotnej - Centrum Neurologii Dzieciecej i Leczenia Padaczki

Kielce, Poland
Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601, United States
Northeast Regional Epilepsy Group - Morristown

Morristown, New Jersey, 07960, United States
Országos Klinikai Idegtudományi Intézet, Neurológiai Osztály

Budapest, Hungary
Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States
Royal Children's Hospital Melbourne

Parkville, Australia
SMG-SNU Boramae Medical Center

Seoul, South Korea
Semmelweis University Dept. Of Paediatrics

Budapest, Hungary
Seoul National University Hospital

Seoul, South Korea
Servus Salvus Egészségügyi Szolgáltató Kft.

Budapest, Hungary
Severance Hospital

Seoul, South Korea
Sydney Children's Hospital - Randwick

Randwick, Australia
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

Krakow, Poland

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