Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT05067634
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
Study:
NCT05067634
Study Brief:
Protocol Section:
NCT05067634