A Study of Tadalafil for Duchenne Muscular Dystrophy
Status:
Terminated
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to determine if tadalafil can slow the decline in walking
ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the
safety of tadalafil and any side effects that might be associated with it in boys who have
DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks
of the study, and can then continue into an open label extension (OLE) that consists of two
periods during which all participants will receive tadalafil. In OLE period 1, all
participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will
continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.