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Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

A Phase I, Open-Label, Pharmacokinetic, Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

NCT04903314•SK Life Science, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing.

Detailed Description

The secondary objective of this study is to evaluate the safety and tolerability of cenobamate (YKP3089) following single and multiple dosing.

Eligibility

Age

2 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of epilepsy with partial-onset 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 6 months prior to Visit 1 by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allows provided that the participant meets the other diagnosis criterion (i.e., clinical history, including a history of treatment failure with at least 2 AEDs)
•2. Male or female subjects, from age 2 to less than 18 years at the time of informed consent
•3. Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds \[lb\])
•4. Written informed consent signed by the subject, legal guardian, or legally authorized representative (LAR) prior to entering the study in accordance with the ICH GCP guidelines. Age appropriate assent will be obtained for children and adolescents. If the written informed consent is provided by the legal guardian or LAR because the subject is unable to do so, a written or verbal assent from the subject must also be obtained
•5. Are currently being treated with stable doses of 1 to a maximum of 2 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a participant, the dose must be stable for at least 8 weeks prior to Visit 1. A vagal nerve stimulator (VNS) will not be counted as one of the 2 allowable AEDs
•6. In the Investigator's opinion, parents or caregivers must be able to report accurate seizure assessments during the screening and study periods and subjects must be able to ingest study drug
•7. Subjects with an implanted vagal nerve stimulator will be allowed if the vagal nerve stimulator was implanted at least 5 months prior to Visit 1 (Screening) and the stimulator parameters have not been changed for 30 days prior to Visit 1 and for the duration of the study
•8. 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. Progressive neurological disease, including degenerative CNS diseases and progressive tumors
•2. Evidence of clinically significant disease or any medical condition that would compromise the subject's ability to safely complete the study including, but not limited to, hepatic or renal failure, ischemic disease, human immunodeficiency virus (HIV) infection, active sexually transmitted disease (STD), active viral hepatitis, or malignancy
•3. Positive urine screen of drugs of abuse (if not due to concomitant medication, e.g., benzodiazepines as hypnotics) for Cohort 1 subjects.
•4. History of anoxic episodes require resuscitation within 6 months before Visit 1, drug or alcohol dependency or abuse within approximately the last 2 years or use of illegal recreational drugs.
•5. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product
•6. Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 72 hours before Day 1 and 72 hours before the day of multiple dose PK sampling (Day 59 for Cohort I)
•7. Consumption of grapefruit or grapefruit-containing products within 72 hours before Day 1 and 72 hours before the day of multiple dose PK sampling (Day 59 for Cohort I)
•8. Significant clinical laboratory abnormalities, including elevation of serum AST or ALT more than 2 times the upper limit or normal (ULN) for each age group.
•9. Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before Day 1
•10. Scheduled for surgery during the study
+18 more criteria

Locations (13)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

Missouri University Pediatric and Adolescent Specialty Clinic

Columbia, Missouri, United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, United States

Duke University

Durham, North Carolina, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

MultiCare Institute - Mary Bridge Children's Neurology

Tacoma, Washington, United States

I. Sz. Gyermekgyógyászati Klinika

Budapest, Hungary

Chungbuk National University Hospital

Cheonju, South Korea

Key Dates

Start Date

May 27, 2021

Primary Completion Date

November 6, 2025

Completion Date

November 6, 2025

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Partial Epilepsy

Interventions

Xcopri

DRUG

Surgery as a Treatment for Medically Intractable Epilepsy

NCT01273129

EpilepsyEpilepsy, Temporal Lobe+1 more

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COMPLETEDPHASE2

A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures

NCT00465517

Partial EpilepsyCatamenial Epilepsy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

Inclusion Criteria

Exclusion Criteria

Surgery as a Treatment for Medically Intractable Epilepsy

A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures

Cenobamate Expanded Access Program (EAP)

PRX-00023 Therapy in Localization-Related Epilepsy

Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine

Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy