NCT05067634

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Secondary objectives: * 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

• Partial Epilepsy

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2022-01-14
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2021-10-05
• Last updated: 2026-04-03

Locations

54 sites across 7 countries: United States, Australia, Germany, Hungary, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study