7 results
Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.
The primary objective of this study is to evaluate efficacy and safety. Secondary objectives: PK, PK-PD.
The primary objective of Part 1 is the primary objective of the entire study.Part 1The primary objective of Part 1 is:* To evaluate the effect of ZX008 0.8 mg/kg/day versus placebo as adjunctive therapy for the treatment of uncontrolled seizures in…
The primary efficacy objectives of this two-cohort study are:o To demonstrate that ZX008 is superior to placebo as adjunctive therapy in the treatment of symptoms of Dravet syndrome in children and young adults based on change in the frequency of…
Primary:To compare the efficacy of abrocitinib 200 mg once daily (QD) versus dupilumab (as per label guidelines) in adult participants on background topical therapy with moderate to severe atopic dermatitis (AD).Key SecondaryTo compare the efficacy…
* To assess the long-term safety and tolerability of ZX008.
Objectives for Part 1: Primary (Efficacy): To demonstrate that the efficacy of fenfluramine (ZX008) 0.8 mg/kg/day is superior to placebo as an adjunctive therapy for pediatric and adult subjects with CDD Secondary (Safety): To characterize the…