Clinical Trial

A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy

Study acronym: GUARDIAN
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
This study aims to assess safety and effectivness of long-term treatment with vamorolone in boys with Duchenne Muscular Dystrophy (DMD) who have completed prior studies with vamorolone.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-11-26; most recent amendment 2026-04-22.
Status change: Recruiting → Active, Not Recruiting 2025-12-12
Trial Details
NCT Number NCT06713135
Lead Sponsor Santhera Pharmaceuticals
Conditions Duchenne Muscular Dystrophy
Enrollment 80 participants
Start Date 2024-11-10
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-04-23