Novel study design to assess the efficacy and tolerability of antiseizure medications for focal‐onset seizures in infants and young children: A consensus document from the regulatory task force and the pediatric commission of the International League against Epilepsy (ILAE), in collaboration with the Pediatric Epilepsy Research Consortium (PERC)

Auvin, Stéphane; A. French, Jacqueline; Dlugos, Denis; G. Knupp, Kelly; Perucca, Emilio; Arzimanoglou, Alexis; Whalen, Ed; A. Shellhaas, Renée

doi:10.1002/epi4.12356

Public

Novel study design to assess the efficacy and tolerability of antiseizure medications for focal‐onset seizures in infants and young children: A consensus document from the regulatory task force and the pediatric commission of the International League against Epilepsy (ILAE), in collaboration with the Pediatric Epilepsy Research Consortium (PERC)

Published in Epilepsia Open • Aug 29, 2019

Authors:

Stéphane Auvin

Jacqueline A. French

Denis Dlugos

Abstract

High-quality placebo-controlled drug trials for focal-onset seizures in infants and children younger than 4 years have become increasingly difficult to perform because of eligibility constraints and onerous study designs. Traditional designs used in these populations require a high baseline seizure ...

Subject

Medicine

Placebo

Tolerability

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