4 results
PRIMARY OBJECTIVE To characterize the pharmacokinetics (PK) of single doses of solriamfetolin pediatric subjects with narcolepsy.SECONDARY OBJECTIVE To assess the safety and tolerability of single doses of solriamfetol inpediatric subjects with…
The primary outcome of the study is a 50% reduction in exacerbation rate in patients using TIS once daily (OD). Secondary outcome parameters are lung function (FEV1, FVC), QoL (QOL-B), LTRI-VAS, Leicester cough score), bacterial load in sputum and…
To compare event-free survival (EFS) of the experimental treatment arm including ATO/ATRA and idarubicin with standard treatment based on ATRA plus chemotherapy (AIDA regimen).
Primary objective:To assess, in an international pediatric study, the efficacy, in terms of event-free survival, of a combination of ATO and ATRA in newly diagnosed SR APL children and adolescents and to explore the safety and efficacy of a…