BridgeMD
An open-label study to collect safety and effectiveness information on long-term treatment with vamorolone in boys with Duchenne Muscular Dystrophy who have completed prior studies with vamorolone (The GUARDIAN Study)
EU CTIS ID: 2024-512828-12-00
What this study is testing
To evaluate the safety of long-term treatment with vamorolone in boys with DMD regarding vertebral fractures
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject and/or subject’s parent(s) or legal guardian has provided written informed consent
- Subject has previously completed either the VBP15-LTE or VBP15-004 study, and transitioned through the CUP, NPP or EAP
- Subject is on vamorolone on the day of enrolment
- Subject and parent / legal guardian are willing and able to comply with the protocol schedule, assessments and requirements
You likely can't join if
- Any medical condition, which in the opinion of the Investigator, would affect study participation, performance or interpretation of study assessments
- Vamorolone treatment discontinued for ≥6 months within the year prior to enrolment for a non-safety reason, or vamorolone treatment previously discontinued at any time for a safety reason
- Severe hepatic impairment
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- New Zealand
- United Kingdom
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; New Zealand; United Kingdom; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.