Considerations for determining the efficacy of new antiseizure medications in children age 1 month to younger than 2 years.

ABSTRACT:

Objectives

Drug treatment for children with epilepsy should, ideally, be governed by evidence from adequate and well-controlled clinical studies. However, these studies are difficult to conduct, and so direct evidence supporting the informed use of specific drugs is often lacking. The Research Roundtable for Epilepsy (RRE) met in 2020 to align on an approach to therapy development for focal seizures in children age 1 month <2 years of age.

Methods

The RRE reviewed the regulatory landscape, epidemiology, seizure semiology, antiseizure medicine pharmacology, and safety issues applicable to this population.

Results

After reviewing evidence, the conclusion was that pediatric efficacy trials would be impracticable to conduct but a waiver of the regulatory requirement to co

SUBMITTER: French JA 

PROVIDER: S-EPMC9804346 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature