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Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

NCT03863119 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-01-20

No results posted yet for this study

Summary

The intent of this protocol is to provide continued access to vamorolone for subjects in the United States and Canada who have completed the VBP15-LTE, VBP15- 004, or VBP15-006 protocols (and are thereby ineligible to enroll in another trial of vamorolone therapy), during the time a new drug application for vamorolone is under preparation and review.

Conditions

Interventions

DRUG

Vamorolone

2.0 mg/kg/day, 4.0 mg/kg/day, or 6.0 mg/kg/day at physician discretion

Sponsors & Collaborators

  • Santhera Pharmaceuticals

    lead INDUSTRY

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States
  • Canada
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03863119 on ClinicalTrials.gov