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

Partial Epilepsy Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05067634
Study type Interventional
Source SK Life Science, Inc.
Contact Meagan Whritner
Phone 201-431-7812
Email mwhritner@sklsi.com
Status Recruiting
Phase Phase 3
Start date January 14, 2022
Completion date July 2026
View Details
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