Summary

Eligibility
for males (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

The VILT-502 study is Non-interventional Study(United States)/Low-intervention Clinical Trial (Canada) of Viltolarsen administered intravenously once weekly for 10 years to boys with DMD who complete the NS-065/NCNP-01-202 study.

Details

The VILT-502 study is an open-label, single-arm study to assess the long-term safety and effectiveness of viltolarsen, an exon skipping therapy for the treatment of DMD. Patients who complete the Phase II long-term extension study and meet the additional inclusion and exclusion criteria of the present protocol will be invited to enroll. Viltolarsen will be administered through weekly IV infusions, at the study site or at home.

The VILT-502 study will be conducted as a non-interventional study in the US, and as a low-intervention clinical trial in Canada where viltolarsen is not yet commercially available, owing to differences in the stage of regulatory approval in the two countries.

Keywords

Duchenne Muscular Dystrophy, Muscular Dystrophies, Viltolarsen

Eligibility

Locations

  • UC Davis
    Sacramento California 95817 United States
  • Alberta Children's Hospital
    Calgary Alberta T3B 6A8 Canada

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NS Pharma, Inc.
ID
NCT04687020
Phase
Phase 4 Duchenne Muscular Dystrophy Research Study
Study Type
Interventional
Participants
About 9 people participating
Last Updated