Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
← catalyst calendarNCT04433234 · readout in 165 d
Sponsored by Daiichi Sankyo Co., Ltd. (industry) · 4568.T — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
8estimated
Sites
2
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-06-30 | actual | When the study began enrolling |
| Primary completion | 2027-01-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-31 | estimated | The whole study's end, after follow-up |
| First posted | 2020-06-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Duchenne Muscular Dystrophy
Intervention
- Drug: DS-5141b — also filed as Renadirsen
Primary outcomes
what the primary-completion date above is the date OFIncidence of Adverse Events (AEs)
measured From first injection to after the last injection of DS-5141b in this study (within approximately 2 years)
Change in distance walked during 6-minute walk test (6MWT)
measured Every 3 months (within approximately 2 years)
Change in time to stand (TTSTAND)
measured Every 3 months (within approximately 2 years)
Change in time in Timed up and go test
measured Every 3 months (within approximately 2 years)
Change in time in 10-meter Run/Walk test
measured Every 3 months (within approximately 2 years)
Change in score in the North Star Ambulatory Assessment (NSAA)
measured Every 3 months (within approximately 2 years)
Change in score in the Performance of Upper Limb (PUL)
measured Every 3 months (within approximately 2 years)
Change in Left Ventricular Ejection Fraction percentage (LVEF %)
measured Every 6 months (within approximately 2 years)
Change in in Forced Vital Capacity (FVC) (percent predicted)
measured Every 6 months (within approximately 2 years)
Change in Muscle Strength Measured by Quantitative Muscle Strength Assessment
measured Every 3 months (within approximately 2 years)
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