Overview

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

Status:
Active, not recruiting

Trial end date:
2022-03-01

Target enrollment:

Participant gender:

Summary

it is a randomised, double blind, parallel group, placebo controlled study. A total of 179 male ambulant subjects will be randomised 2:1 (givinostat:placebo). Subjects will be stratified for their concomitant use of steroids in 4 strata: 1. Deflazacort daily regimen 2. Deflazacort intermittent regimen 3. Other steroids daily regimen 4. Other steroids intermittent regimen. The study duration is planned for 19 months.

Phase:

Phase 3

Details

Lead Sponsor:

Italfarmaco

Collaborators:

inVentiv Health Clinical
Syneos Health