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Active, not recruiting

NCT Number: NCT04433234

Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Duchenne Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

5 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

National Center of Neurology and Psychiatry, Tokyo, Kodaira-Shi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has competed a study of DS5141-A-J101

Exclusion criteria

  • 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

Treatment and study plan

DS-5141b

Drug

Administered via subcutaneous injection once weekly

Other names: Renadirsen

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: From first injection to after the last injection of DS-5141b in this study (within approximately 2 years)

  2. Change in distance walked during 6-minute walk test (6MWT)

    Time frame: Every 3 months (within approximately 2 years)

  3. Change in time to stand (TTSTAND)

    Time frame: Every 3 months (within approximately 2 years)

  4. Change in time in Timed up and go test

    Time frame: Every 3 months (within approximately 2 years)

  5. Change in time in 10-meter Run/Walk test

    Time frame: Every 3 months (within approximately 2 years)

  6. Change in score in the North Star Ambulatory Assessment (NSAA)

    Time frame: Every 3 months (within approximately 2 years)

  7. Change in score in the Performance of Upper Limb (PUL)

    Time frame: Every 3 months (within approximately 2 years)

  8. Change in Left Ventricular Ejection Fraction percentage (LVEF %)

    Time frame: Every 6 months (within approximately 2 years)

  9. Change in in Forced Vital Capacity (FVC) (percent predicted)

    Time frame: Every 6 months (within approximately 2 years)

  10. Change in Muscle Strength Measured by Quantitative Muscle Strength Assessment

    Time frame: Every 3 months (within approximately 2 years)

Secondary outcomes

  1. Concentration of DS-5141a in plasma

    Time frame: Every 3 months (within approximately 2 years)

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

A Phase II, Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2020
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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