2 results
Approved WMOCompleted
Primary:To determine the safety, tolerability, and pharmacokinetic (PK) profile of single ascending intravenous (iv) doses and of multiple ascending iv doses of FMX-8 in healthy subjectsSecondary:To evaluate the pharmacodynamics (PD) of FMX-8 in…
Approved WMOCompleted
- To evaluate the efficacy of pitolisant ( 5, 10, 20,40mg/d in the Double Blind Period and 5, 10, 15, 20, 30, 40mg/d in the Open Label Period) in reducing residual Excessive Daytime Sleepiness (EDS) and the number of cataplectic episodes (for…