5 results
Primary objective:The primary objective is the difference between the gammaCore®-R and the sham treatment groups in mean reduction in number of episodic migraine days during the last four weeks in the twelve-week randomized period compared with the…
The primary goal of this study is to investigate whether placebo-controlled double-blind titration leads to optimizing the use of methylphenidate. This by detecting placebo-and non-responders more efficiently and by treating responders better so…
Primary: • Demonstrate superior efficacy (increased progression-free survival [PFS]) of MEK162 vs. physician*s choice of selected chemotherapies (liposomal doxorubicin, paclitaxel and topotecan)Key Secondary: • Demonstrate superior efficacy (…
Primary Objectives• Safety and tolerability• PK of OCA and its conjugates o SD PK Phase: To assess the PK of OCA and its conjugates after a single low dose of OCA on Day 1 and determine subject eligibility for the MD Phase o MD Phase: To assess the…
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase(ALP) in comparison to BZF alone in subjects with primary biliary cholangitis (PBC)To assess the effects of the combination of OCA and BZF in…