Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study

Abstract Objective A good knowledge of safety and age group-specific pharmacokinetics (PK) of antiepileptic drugs (AEDs) in young pediatric patients is of great importance in clinical practice. This paper presents 6-month interim safety and PK from an ongoing 2-year open-label study (Study 303) of a...

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Bibliographic Details
Published in:European journal of paediatric neurology 2016-05, Vol.20 (3), p.393-402
Main Authors: Arzimanoglou, Alexis, Ferreira, Jose A, Satlin, Andrew, Mendes, Shannon, Williams, Betsy, Critchley, David, Schuck, Edgar, Hussein, Ziad, Kumar, Dinesh, Dhadda, Shobha, Bibbiani, Francesco
Format: Article
Language:English
Subjects:
Anticonvulsants - adverse effects
Anticonvulsants - pharmacokinetics
Antiepileptic drug therapy
Child, Preschool
Female
Humans
Infant
Infants
Lennox Gastaut Syndrome - drug therapy
Lennox-Gastaut syndrome
Male
Neurology
Pediatrics
Pharmacokinetic
Randomized study
Rufinamide
safety
Triazoles - adverse effects
Triazoles - pharmacokinetics
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Summary:Abstract Objective A good knowledge of safety and age group-specific pharmacokinetics (PK) of antiepileptic drugs (AEDs) in young pediatric patients is of great importance in clinical practice. This paper presents 6-month interim safety and PK from an ongoing 2-year open-label study (Study 303) of adjunctive rufinamide treatment in pediatric subjects ≥1 to
ISSN:1090-3798
1532-2130
DOI:10.1016/j.ejpn.2015.12.015