Extension Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)

Completed · Phase 2

Conditions studied: Duchenne Muscular Dystrophy

In brief

This is an open-label, extension study of NS-065/NCNP-01 administered intravenously once weekly for an additional 192 weeks to boys with DMD who complete Study NS-065/NCNP-01-201.

Key facts

Study ID

NCT03167255

Run by

NS Pharma, Inc.

People needed

16

Starts

2017-07-06

Expected to finish

2021-11-15

Last updated by the study team

2022-12-28

Who can join

Age: 4 and older, up to 10. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Completed Study NS-065/NCNP-01-201 through Week 25.
• Willing and able to comply with scheduled visits, investigational product administration plan, and study procedures.
• Stable dose of glucocorticoid (GC), and is expected to remain on the stable dose for the duration of the study.

You may not qualify if…

• Serious or severe adverse event in Study NS-065/NCNP-01-201 that precludes safe use of NS-065/NCNP-01.
• Patient had a treatment which was made for the purpose of dystrophin or its related protein induction after completion of Study NS-065/NCNP-01-201.
• Patient took any other investigational drugs after completion of Study NS-065/NCNP-01-201.
• Patient was judged by the investigator and/or the Sponsor that it was not appropriate to participate in the extension study for other reasons.

Where it is running

• UC Davis — Sacramento, California, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• Washington University — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital of Richmond at VCU — Richmond, Virginia, United States
• Alberta Children's Hospital — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.