Efficacy and tolerability of adjunctive lacosamide in patients aged <4 years with focal seizures.

ABSTRACT:

Objective

Primary objective was to evaluate efficacy of lacosamide administered concomitantly with 1-3 antiseizure medications in young children with uncontrolled focal (partial-onset) seizures.

Methods

Double-blind, parallel-group trial (SP0967: NCT02477839/2013-000717-20) conducted between June 2015 and May 2020 at hospitals and clinics in 25 countries. Patients (aged ≥1 month to <4 years) with uncontrolled focal seizures were randomized 1:1 to adjunctive lacosamide or placebo using an interactive voice/web response system and stratified by age. After a 20-day titration period, patients who reached target-dose range (8-12 mg/kg/day) entered a 7-day maintenance period. Region-specific primary efficacy variables were based on ≤72-h video-electroencephalograms: change in aver

SUBMITTER: Makedonska I 

PROVIDER: S-EPMC10963285 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature