Duchenne Muscular Dystrophy
Conditions
Brief summary
Incidence of treatment-emergent adverse events, Incidence of serious adverse events, Incidence of adverse events of special interest, Clinically significant changes in vital signs and physical examination findings, Clinically significant changes in safety laboratory assessments, ECGs, and ECHOs
Detailed description
Change in quantity of SRP-9001-dystrophin protein expression from baseline to Week 12 as measured by Western blot
Interventions
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
Male
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events, Incidence of serious adverse events, Incidence of adverse events of special interest, Clinically significant changes in vital signs and physical examination findings, Clinically significant changes in safety laboratory assessments, ECGs, and ECHOs | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quantity of SRP-9001-dystrophin protein expression from baseline to Week 12 as measured by Western blot | — |
Countries
Belgium, France, Germany, Italy, Spain
Outcome results
None listed