Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT05067634
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2021-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
Sponsor:
SK Life Science, Inc.
Organization:
Study Overview
Official Title:
Open-Label Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: