Léonore Diezi, Kim Dao, Vincent Jullien, Caroline Roussel-Maupetit, Ingrid Burton, Pascal André, Carine Bardinet, Laura E Rothuizen, Haithem Chtioui, Maria A Manso-Silvan, Catherine Guittet, Françoise Brunner-Ferber, Francois Vandenhende, Catherine Chiron, Luc-André Granier, Thierry Buclin
Ethosuximide, the first-line therapy for childhood absence epilepsy, is currently formulated as a syrup (Zarontin®, Pfizer) with a bitter taste and high sugar content, poorly adapted to children, and a ketogenic diet. The collaborative European FP7 project KIEKIDS aimed at developing an innovative sugar-free, tasteless formulation convenient for pediatric use. This dual Phase-I study evaluated two granule formulations based on lipid multiparticulate (LMP) technology. Two panels of 6 healthy adult volunteers underwent a randomized, placebo-controlled, partly blinded, 3-way cross-over trial, comparing ethosuximide granules A or B with placebo granules and syrup at single 10 mg/kg doses...
February 2023: Pharmacology Research & Perspectives