Trials / Active Not Recruiting
Active Not RecruitingNCT05135663
Extension Study of NS-089/NCNP-02 in DMD
A Phase II, Open-Label, Extension Study of NS-089/NCNP-02 in Patients With Duchenne Muscular Dystrophy
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Nippon Shinyaku Co., Ltd. · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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). |
| DRUG | 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). |
Timeline
- Start date
- 2021-06-23
- Primary completion
- 2027-04-30
- Completion
- 2027-04-30
- First posted
- 2021-11-26
- Last updated
- 2025-07-20
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05135663. Inclusion in this directory is not an endorsement.