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| ID | Type | Description | Link |
|---|---|---|---|
| 205321 | Other Identifier | JapicCTI |
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This is a multicenter, open-label, long-term, extension, phase 2 study to evaluate the safety and efficacy of long-term treatment with DS-5141b in patients with DMD who have completed DS5141-A-J101.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-5141b 2.0 mg/kg | Experimental | Participants who will receive DS-5141b 2.0 mg/kg once weekly. |
|
| DS-5141b 6.0 mg/kg | Experimental | Participants who will receive DS-5141b 6.0 mg/kg once weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-5141b | Drug | Administered via subcutaneous injection once weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | 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) | Every 3 months (within approximately 2 years) | |
| Change in time to stand (TTSTAND) | Every 3 months (within approximately 2 years) | |
| Change in time in Timed up and go test | Every 3 months (within approximately 2 years) | |
| Change in time in 10-meter Run/Walk test | Every 3 months (within approximately 2 years) | |
| Change in score in the North Star Ambulatory Assessment (NSAA) | Every 3 months (within approximately 2 years) | |
| Change in score in the Performance of Upper Limb (PUL) | Every 3 months (within approximately 2 years) | |
| Change in Left Ventricular Ejection Fraction percentage (LVEF %) | Every 6 months (within approximately 2 years) | |
| Change in in Forced Vital Capacity (FVC) (percent predicted) | Every 6 months (within approximately 2 years) | |
| Change in Muscle Strength Measured by Quantitative Muscle Strength Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of DS-5141a in plasma | Every 3 months (within approximately 2 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Leader | Daiichi Sankyo Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Neurology and Psychiatry | Tokyo | Kodaira-Shi | 187-8551 | Japan | ||
| Kobe University Hospital |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| Every 3 months (within approximately 2 years) |
| Hyōgo |
| 650-0017 |
| Japan |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |