Considerations for determining the efficacy of new antiseizure medications in children age 1 month to younger than 2 years-Reference-Cited by-同舟云学术

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

Published:2022-08-12 Issue:10 Volume:63 Page:2664-2670
ISSN:0013-9580
Container-title:Epilepsia
language:en
Short-container-title:Epilepsia

Author:

French Jacqueline A.¹^ORCID,Cleary Elena²,Dlugos Dennis³,Farfel Gail⁴,Farrell Kathleen⁵^ORCID,Gidal Barry⁶,Grzeskowiak Caitlin L.⁵^ORCID,Gurrell Rachel⁷,Harden Cynthia⁸,Stalvey Tracy J.⁹,Tsai Julia¹⁰,Wirrell Elaine C.¹¹^ORCID,Blum David¹²,Fountain Nathan¹³^ORCID

Affiliation:

1. New York University Comprehensive Epilepsy Center New York New York USA

2. UCB Pharma Morrisville North Carolina USA

3. Departments of Neurology and Pediatrics Children's Hospital of Philadelphia, Perelman Philadelphia Pennsylvania USA

4. Zogenix, a UCB Company Emeryville California USA

5. Research and New Therapies Program Epilepsy Foundation of America Maryland USA

6. University of Wisconsin School of Pharmacy Madison Wisconsin USA

7. Cerevel Therapeutics Cambridge Massachusetts USA

8. Clinical Development Division Xenon Pharmaceuticals Inc. Burnaby British Columbia Canada

9. Stalvey Consulting Dripping Springs Texas USA

10. Ovid Therapeutics New York New York USA

11. Divisions of Child and Adolescent Neurology and Epilepsy, Department of Neurology Mayo Clinic Rochester Minnesota USA

12. Consultant Santa Barbara California USA

13. Department of Neurology University of Virginia Charlottesville Virginia USA

Publisher

Wiley

Subject

Neurology (clinical),Neurology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/epi.17366

Reference16 articles.

1. Reducing placebo exposure in trials

2. EMA.Guideline on Clinical Investigation of Medicinal Products in the Treatment of Epileptic Disorders. [Internet];2018.https://www.ema.europa.eu/en/documents/scientific‐guideline/draft‐guideline‐clinical‐investigation‐medicinal‐products‐treatment‐epileptic‐disorders‐revision‐3_en.pdf. Accessed on February 7 2022.

3. FDA.Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older Guidance for Industry. [Internet];2019.www.fda.gov/media/130449/download. Accessed on February 7 2022.

4. Efficacy of antiepileptic drugs in adults predicts efficacy in children: A systematic review

5. FDA.Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older Guidance for Industry. [Internet];2018.www.fda.gov/media/110916/download. Accessed on February 7 2022.

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