4 results
The primary objective of this study is to document the incidence of unanticipated device and procedure related adverse events intra-operatively and through one year follow-up.
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…
• To assess the tolerability and safety of the investigational medicinal product