Offered by: Nemours Children's
Location: Orlando, Fla.
Givinostat vs. Placebo/Duchenne Muscular Dystrophy — Phase 3-Italfarmaco Protocol #DSC/14/2357/48
This is a blind study to learn how well a medicine called Givinostat (the study drug) works for boys with Duchenne Muscular Dystrophy (DMD), and to see how safe Givinostat is compared to a placebo (a placebo looks like the study drug but does not contain any active study drug).
Ambulant males aged ≥ 6 years with DMD signs or symptoms; DMD diagnosis confirmed by genetic testing; able to complete two (2) Four Stairs Climb test; taking a stable dose of steroids for minimum of six months.
The length of the study is approximately 20 months (about two years). The study is divided into two time periods: a screening period (which will start about four weeks before the first dose of study drug) and a treatment period (which will include 18 months of treatment with the study drug).
Study Visits: 15 study visits through the treatment period (three of the study visits may be completed at participant's home or at regular doctor’s office). At the end of the study (about one month after the last dose of study drug), if participant does not continue in the long-term follow-up study, there will be a final follow-up visit.
At the end of the 18-month treatment period of this study, there will be the option to participate in a long-term study.
Trial Name: Givinostat vs. Placebo/Duchenne Muscular Dystrophy — Phase 3-Italfarmaco Protocol #DSC/14/2357/48
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