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A Phase II, long-term, extension study of DS-5141b in Patients With Duchenne Muscular Dystrophy

A Phase II, long-term, extension study of DS-5141b in Patients With Duchenne Muscular Dystrophy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080225225
Enrollment
8
Registered
2020-06-11
Start date
2020-06-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne muscular dystrophy

Interventions

investigational material(s) Generic name etc : DS-5141b INN of investigational material : renadirsen Therapeutic category code : 49- Other agents affecting cellular function Dosage and Administration

Sponsors

DAIICHI SANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Has competed a study of DS5141-A-J101.

Exclusion criteria

Exclusion criteria: 1) Significant safety issues in a study of DS5141-A-J101 2) Patient who does not consent to use appropriate contraception 3) Patient who was judged by the investigator that is not appropriate to participate in this study

Design outcomes

Primary

MeasureTime frame
safety efficacy Adverse events, Laboratory tests, etc. Motor function, Respiratory function, Cardiac function, Quantitative muscle strength evaluation

Secondary

MeasureTime frame
pharmacokinetics plasma concentration of DS-5141a

Countries

Japan

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial_jp@daiichisankyo.com+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026