2 results
Approved WMOCompleted
The primary safety endpoint is to evaluate a 30-day major adverse event (MAE) rate, where MAE is a composite of the following device- or procedure-related events: * All-cause mortality* Stroke* Life-threatening bleeding (MVARC scale)* Major vascular…
Approved WMOCompleted
Primary objectives: 1. To compare the efficacy of vamorolone administered orally at daily doses of 6.0 mg/kg over a 24-week treatment period vs. placebo in ambulant boys ages 4 to <7 years with DMD; and2. To evaluate the safety and…