Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
NCT ID: NCT05067634
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
140 participants
INTERVENTIONAL
2022-01-14
2026-07-31
Brief Summary
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Detailed Description
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* To evaluate the efficacy of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures
* To evaluate the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset seizures
* To evaluate the PK/pharmacodynamics of cenobamate in pediatric subjects with partial onset (focal) seizures
* Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and the 12.5 mg tablets - Day 1, and Day 15
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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12 to < 18 year olds
Xcopri
Age groups 12 to \<18 will enroll once dosing data is received from Cohort I of the PK analysis of YKP3089C039 study. Age groups 6 to \<12 will enroll once dosing data is received from Cohort IIa of the PK analysis of YKP3089C039 study. Age groups 4 to \<6 will enroll once dosing data is received from Cohort IIb of the PK analysis of YKP3089C039 study. Age groups 2 to \<4 will enroll once dosing data is received from Cohort III of the PK analysis of YKP3089C039 study.
6 to <12 years old
Xcopri
Age groups 12 to \<18 will enroll once dosing data is received from Cohort I of the PK analysis of YKP3089C039 study. Age groups 6 to \<12 will enroll once dosing data is received from Cohort IIa of the PK analysis of YKP3089C039 study. Age groups 4 to \<6 will enroll once dosing data is received from Cohort IIb of the PK analysis of YKP3089C039 study. Age groups 2 to \<4 will enroll once dosing data is received from Cohort III of the PK analysis of YKP3089C039 study.
4 to <6 years old
Xcopri
Age groups 12 to \<18 will enroll once dosing data is received from Cohort I of the PK analysis of YKP3089C039 study. Age groups 6 to \<12 will enroll once dosing data is received from Cohort IIa of the PK analysis of YKP3089C039 study. Age groups 4 to \<6 will enroll once dosing data is received from Cohort IIb of the PK analysis of YKP3089C039 study. Age groups 2 to \<4 will enroll once dosing data is received from Cohort III of the PK analysis of YKP3089C039 study.
2 to <4 years old
Xcopri
Age groups 12 to \<18 will enroll once dosing data is received from Cohort I of the PK analysis of YKP3089C039 study. Age groups 6 to \<12 will enroll once dosing data is received from Cohort IIa of the PK analysis of YKP3089C039 study. Age groups 4 to \<6 will enroll once dosing data is received from Cohort IIb of the PK analysis of YKP3089C039 study. Age groups 2 to \<4 will enroll once dosing data is received from Cohort III of the PK analysis of YKP3089C039 study.
Interventions
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Xcopri
Age groups 12 to \<18 will enroll once dosing data is received from Cohort I of the PK analysis of YKP3089C039 study. Age groups 6 to \<12 will enroll once dosing data is received from Cohort IIa of the PK analysis of YKP3089C039 study. Age groups 4 to \<6 will enroll once dosing data is received from Cohort IIb of the PK analysis of YKP3089C039 study. Age groups 2 to \<4 will enroll once dosing data is received from Cohort III of the PK analysis of YKP3089C039 study.
Eligibility Criteria
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Inclusion Criteria
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
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
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.
2 Years
18 Years
ALL
No
Sponsors
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SK Life Science, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Kamin, MD
Role: STUDY_DIRECTOR
SK Life Science, Inc.
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
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
Massachusetts General Hospital
Boston, Massachusetts, 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
Royal Children's Hospital Melbourne
Parkville, , Australia
Sydney Children's Hospital - Randwick
Randwick, , Australia
Children's Health Queensland Hospital and Health Service
South Brisbane, , Australia
Charite University Hospital
Berlin, , Germany
Diakonie Kork
Kehl, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, , Germany
Neurologische Klinik und Poliklinik Interdisziplinäres Epilepsiezentrum München
Munich, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Bethesda Gyermekkorhaz
Budapest, , Hungary
Országos Klinikai Idegtudományi Intézet, Neurológiai Osztály
Budapest, , Hungary
Semmelweis University Dept. Of Paediatrics
Budapest, , Hungary
Servus Salvus Egészségügyi Szolgáltató Kft.
Budapest, , Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, , Hungary
Niepubliczny Zaklad Opieki Zdrowotnej - Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, , Poland
Chungbuk National University Hospital
Cheonju, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hospital Sant Joan de Déu Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, , Spain
Instituto de Investigación Sanitaria de la Fundación Ramón Domínguez
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Arkady Barber
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Susan Fong
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Steven Phillips
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Other Identifiers
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YKP3089C040
Identifier Type: -
Identifier Source: org_study_id
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