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ACTIVE NOT RECRUITING
NCT05135663
PHASE2

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

Sponsor: Nippon Shinyaku Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: A Phase II, Open-Label, Extension Study of NS-089/NCNP-02 in Patients With Duchenne Muscular Dystrophy

Key Details

Gender

MALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2021-06-23

Completion Date

2027-04-30

Last Updated

2025-07-20

Healthy Volunteers

No

Interventions

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).

Locations (2)

Kagoshima University Hospital

Kagoshima, Japan

National Center of Neurology and Psychiatry

Tokyo, Japan