Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

Running, not enrolling · Phase 3

Conditions studied: Partial Epilepsy

In brief

Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Key facts

Study ID

NCT05067634

Run by

SK Life Science, Inc.

People needed

140

Starts

2022-01-14

Expected to finish

2026-11-01

Last updated by the study team

2026-04-03

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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)
• Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds [lb])
• 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.
• 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
• 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).
• Investigator believes subject could benefit from new or continued exposure to study drug
• Subjects entering from study YKP3089C039 must continue to meet all of the inclusion criteria from the YKP3089C039 study
• Subjects receiving felbamate as a concomitant AED must meet the following criteria:
• 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).
• No prior or known history of hepatotoxicity or hematologic disorder due to felbamate.
• 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

You may not qualify if…

• Females who are breastfeeding or pregnant at Screening or Baseline.
• Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 2 years before Visit 1 (Screening).
• Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1 (Screening).
• 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).
• 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].
• 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.
• 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.
• Presence of only nonmotor simple partial seizures or primary generalized epilepsies.
• 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.
• 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).
• 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).
• Subjects with Familial short QT syndrome.
• 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.
• Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
• 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.
• History of AED-associated rash that involved conjunctiva or mucosae.
• History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication.
• 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.
• 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).
• 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).
• 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.
• 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.
• Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
• For subjects new to Study YKP3089C040 previous exposure to cenobamate or sensitivity/allergy to components of the oral suspension.

Where it is running

• Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States
• University of California Davis Health — Sacramento, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• Clinical Integrative Research Center of Atlanta — Sandy Springs, Georgia, United States
• Meridian Clinical Research - Savannah Neurology Specialists — Savannah, Georgia, United States
• Kentucky Clinic — Lexington, Kentucky, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Spectrum Health Hospitals Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• University of Missouri Health Care - Women's and Children's Hospital — Columbia, Missouri, United States
• Northeast Regional Epilepsy Group — Hackensack, New Jersey, United States
• Northeast Regional Epilepsy Group - Morristown — Morristown, New Jersey, United States
• Boston Children's Health Physicians - Neurology at Hawthorne — Hawthorne, New York, United States
• Duke University Hospital — Durham, North Carolina, United States
• Akron Children's Hospital NeuroDevelopmental Science Center/Pediatric Neurology — Akron, Ohio, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic Main Campus — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States
• Child Neurology Consultants of Austin — Austin, Texas, United States
• Scottish Rite for Children — Dallas, Texas, United States
• MultiCare Institute - Mary Bridge Children's Neurology — Tacoma, Washington, United States
• Austin Health — Heidelberg, Australia
• Phoenix Children's Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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