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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.
The secondary objective of this study is to evaluate the safety and tolerability of cenobamate (YKP3089) following single and multiple dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I | Experimental | Xcopri to be administered to ages 12 to < 18 years not to exceed 400 mg/day. |
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| Cohort IIa | Experimental | Xcopri to be administered to ages 6 to < 12 years not to exceed 400 mg/day. |
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| Cohort IIb | Experimental | Xcopri to be administered to ages 4 to < 6 years not to exceed 400 mg/day. |
|
| Cohort III | Experimental | Xcopri to be administered to ages 2 to < 4 years not to exceed 400 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xcopri | Drug | Xcopri will be administered orally not to exceed 400mg/day adult equivalent |
|
| Measure | Description | Time Frame |
|---|---|---|
| The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri | Safety Assessment | 18 Months |
| The maximum plasma concentration (Cmax) after a single and multiple doses of Xcopri | Safety Assessment | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - adverse events (AEs) reporting after a single and multiple doses of Xcopri | Adverse event assessment for seriousness (yes, no), severity (mild, moderate, severe), affect on Xcopri dosing (increase, reduced, interrupted, withdrawn, no change), and outcome (recovered/resolved,recovered/resolved with sequelae, recovering/resolving, not recovered/not resolved, fatal or unknown). | 18 Months |
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Inclusion Criteria:
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 | ||
| Mid-Atlantic Epilepsy and Sleep Center |
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Cohort I will enroll 6 subjects. Upon review of Cohort I's PK analysis, a dose will be determined for Cohort IIa. Upon review of Cohot IIa's PK analysis, a dose will be determined for Cohort 11b and Cohort III.
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| Bethesda |
| Maryland |
| 20817 |
| United States |
| Missouri University Pediatric and Adolescent Specialty Clinic | Columbia | Missouri | 65201 | United States |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| MultiCare Institute - Mary Bridge Children's Neurology | Tacoma | Washington | 98405 | United States |
| I. Sz. Gyermekgyógyászati Klinika | Budapest | Hungary |
| Chungbuk National University Hospital | Cheonju | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| 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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