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)

Author:

Auvin Stéphane12ORCID,French Jacqueline3ORCID,Dlugos Denis45,Knupp Kelly G.6,Perucca Emilio7,Arzimanoglou Alexis8,Whalen Ed9,Shellhaas Renée A.10ORCID

Affiliation:

1. Department of Pediatric Neurology AP‐HP Robert‐Debré University Hospital CRMR Epilepsies Rares Paris France

2. Université de Paris INSERM U1141 Paris France

3. NYU Langone School of Medicine New York NY USA

4. Division of Neurology Children's Hospital of Philadelphia (CHOP) Philadelphia PA USA

5. Departments of Neurology and Pediatrics Perelman School of Medicine at the University of Pennsylvania Philadelphia PA USA

6. Department of Pediatrics and Neurology University of Colorado Aurora CO USA

7. Department of Internal Medicine and Therapeutics Member of the ERN EpiCARE University of Pavia and IRCCS Mondino Foundation Pavia Italy

8. Department of Clinical Pediatric Epileptology and Functional Neurology Member of the ERN EpiCARE University Hospitals of Lyon (HCL) Lyon France

9. Global Biometrics and Data Management Pfizer Inc New York NY USA

10. Division of Pediatric Neurology Department of Pediatrics Michigan Medicine Ann Arbor MI USA

Publisher

Wiley

Subject

Clinical Neurology,Neurology

Reference18 articles.

1. Incidence of Epileptic Syndromes in Rochester, Minnesota: 1980-1984

2. Off-Label Prescribing of Antiepileptic Drugs in Pharmacoresistant Epilepsy: A Cross-Sectional Drug Utilization Study of Tertiary Care Centers in Italy

3. Off-label use and manipulations of antiepileptic drugs in children: Analysis of the outpatient prescriptions in a tertiary center

4. https://www.fda.gov/drugs/development-resources/pediatric-research-equity-act-prea. Accessed May 18 2019.

5. European Union ‐ Drug development.https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf. Accessed May 18 2019.

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