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

• Status: Active, not recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nippon Shinyaku Co., Ltd.

Criteria

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.