4 results
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Efficacy and quality of life.
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
The purpose of this study is to seek regulatory approval for use of fingolimod in a pediatric population with MS aged 10 to less than 18 years old. This study is conducted in line with the Pediatric Investigational Plan agreed with the EMA (under EU…
PrimaryTo evaluate the efficacy of single agent talazoparib in DNA damage repair (DDR) + metastatic CRPC, as measured by best objective responserate (ORR).Secondary:To evaluate efficacy with respect to the following parameters:• Time to objective…