What question did this study set out to answer?

Evaluate the pharmacokinetics of cenobamate in adolescents with focal epilepsy and determine optimal dosing.

June 13, 2026Neurology0 citations

Cenobamate in Adolescent Patients With Focal Epilepsy: A Phase 1 Pharmacokinetic Study to Determine an Appropriate Dosing Regimen to Optimize Safety, Tolerability, and Efficacy (P10-11.003)

VVVijaykumar VashiSK Life Science (United States)GKGopal KrishnaSK Life Science (United States)FJFredrik JönssonSandviken Hospital

Key Points

Evaluate the pharmacokinetics of cenobamate in adolescents with focal epilepsy and determine optimal dosing.
Open-label clinical studies analyzing cenobamate in adolescent patients aged 12 to <18 years old.
Assessment of single- and multiple-dose regimens to optimize dosing for safety and efficacy.
Studies included: C039 (NCT04903314) and C040 (NCT05067634).
Results from pharmacokinetic analysis were obtained from both studies for the adolescent subgroup.
Single and multiple doses were evaluated, emphasizing safety and tolerability across the dosing regimens.

Abstract

To report the pharmacokinetics (PK) of cenobamate single- and multiple-dose regimens in the adolescent subgroup of patients (12 to <18 years old) from the open-label clinical studies (Study C039 NCT04903314 and Study C040 NCT05067634) in pediatric patients (2 to <18 years old) with focal seizures.

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