Status:
ACTIVE_NOT_RECRUITING
Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
5+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Has competed a study of DS5141-A-J101
Exclusion
- Significant safety issues in a study of DS5141-A-J101
- Patient who does not consent to use appropriate contraception
- Patient not appropriate to participant in the study as determined by the Investigator
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04433234
Start Date
June 30 2020
End Date
January 31 2027
Last Update
September 19 2025
Active Locations (2)
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1
National Center of Neurology and Psychiatry
Tokyo, Kodaira-Shi, Japan, 187-8551
2
Kobe University Hospital
Hyōgo, Japan, 650-0017