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Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 to < 18 year olds | Experimental |
| |
| 6 to <12 years old | Experimental |
| |
| 4 to <6 years old | Experimental |
| |
| 2 to <4 years old | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xcopri | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events and SAEs | Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.of age with partial-onset (focal) seizures | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| To collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures | The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri | 3 Years |
| Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and tablets |
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Inclusion Criteria:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sunita Misra, MD | SK Life Science, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Lucile Packard Children's Hospital Stanford |
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|
Testing to determine how patients respond to the taste and route of Xcopri |
| 3 Years |
| Palo Alto |
| California |
| 94304 |
| United States |
| University of California Davis Health | Sacramento | California | 95817 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Clinical Integrative Research Center of Atlanta | Sandy Springs | Georgia | 30328 | United States |
| Meridian Clinical Research - Savannah Neurology Specialists | Savannah | Georgia | 31406 | United States |
| Kentucky Clinic | Lexington | Kentucky | 40536 | United States |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | United States |
| Spectrum Health Hospitals Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| University of Missouri Health Care - Women's and Children's Hospital | Columbia | Missouri | 65212 | United States |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601 | United States |
| Northeast Regional Epilepsy Group - Morristown | Morristown | New Jersey | 07960 | United States |
| Boston Children's Health Physicians - Neurology at Hawthorne | Hawthorne | New York | 10532 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| Akron Children's Hospital NeuroDevelopmental Science Center/Pediatric Neurology | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| Child Neurology Consultants of Austin | Austin | Texas | 78731 | United States |
| Scottish Rite for Children | Dallas | Texas | 75219 | United States |
| MultiCare Institute - Mary Bridge Children's Neurology | Tacoma | Washington | 98405 | 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 |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000654784 | Cenobamate |
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