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)

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)

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...

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Bibliographic Details
Main Authors: Stéphane Auvin, Jacqueline French, Denis Dlugos, Kelly G. Knupp, Emilio Perucca, Alexis Arzimanoglou, Ed Whalen, Renée A. Shellhaas
Format: Article
Language:English
Published: Wiley 2019-12-01
Series:Epilepsia Open
Subjects:
antiseizure drugs
children
clinical trials
drug development
infants
Online Access:https://doi.org/10.1002/epi4.12356

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