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Clinical Trials in Japan / NCT05135663
Active, not recruiting Phase 2

Extension Study of NS-089/NCNP-02 in DMD

NCT05135663 · tracked via the Priya Life Science Japan tracker
Sponsor
Nippon Shinyaku Co., Ltd
Phase
Phase 2
Started
2021-06-23
Last updated
2025-07-20

Condition(s) studied

Duchenne Muscular Dystrophy (DMD)

Investigational drug(s) / intervention(s)

NS-089/NCNP-02 →NS-089/NCNP-02 →

NS-089/NCNP-02: The same dose administered in as Part 2 of Study NCNP/DMT02 (40 mg/kg) will be administered once weekly for 288 weeks (The total treatment period is 312 weeks including Part2 of Study NCNP/DMT02).

NS-089/NCNP-02: The same dose administered in as Part 2 of Study NCNP/DMT02 (80 mg/kg) will be administered once weekly for 288 weeks (The total treatment period is 312 weeks including Part2 of Study NCNP/DMT02).

Study summary

This is the extension study of NS-089/NCNP-02 (Study NCNP/DMT02), which is designed to assess the safety, tolerability and efficacy of NS-089/NCNP-02 in patients with Duchenne muscular dystrophy (DMD).

Eligibility

Sex
MALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient completed Study NCNP/DMT02 Exclusion Criteria: 1. Patient had any serious adverse events in Study NCNP/DMT02 that, in the opinion of the Investigator and/or Sponsor, was probably or definitely related to NS-089/NCNP-02 use and precludes safe use of NS-089/NCNP-02 for the patient in this study. 2. Patient had a treatment which was made for the purpose of dystrophin or dystrophin-related protein induction after completion of Study NCNP/DMT02. 3. Patient took any other investigational drugs after completion of Study NCNP/DMT02. 4. Patient was judged by the investigator and/or the Sponsor that it was not appropriate to participate in the extension study for other reasons.

Primary outcome measure(s)

  • Incidence of adverse events — Up to Week 319

Trial sites (2)

FacilityCityRegionStatus
Kagoshima University Hospital Kagoshima Japan
National Center of Neurology and Psychiatry Tokyo Japan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05135663 on ClinicalTrials.gov ↗ ← All trials in Japan