3 results
Primary Objective: Studying the phenomenon of tolerance by evaluating pharmacokinetic- and dynamic parameters, in patients receiving long-term ITB therapy.Secondary Objective(s): 1.To specify the intrathecal pharmacokinetics and -dynamics of…
The primary objective of the present study is to establish the histological effects of givinostat versus placebo administered over 12 months. The secondary objectives of this study are the following: - To establish the macroscopic muscle effects of…
Primary objective:* To establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects.Secondary objectives:* To assess the safety and tolerability of givinostat versus…