2024-512828-12-00Active, not recruitingPhase 4
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)
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 21 Sept 2026
Brief summary (registry, in English)
To evaluate the safety of long-term treatment with vamorolone in boys with DMD regarding vertebral fractures
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 27 Jun 2024
- Start date
- 5 Dec 2024
- Lead sponsor
- Santhera Pharmaceuticals (Schweiz) AG
- Diseases
- Duchenne muscular dystrophy
- EU CT number
- 2024-512828-12-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 24
- 11 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any medical condition, which in the opinion of the Investigator, would affect study participation, performance or interpretation of study assessments
- Severe hepatic impairment
Who the study is looking for
- Participant and/or participant's parent(s) or legal guardian has provided written informed consent
- Participant has previously completed either the VBP15-LTE or VBP15-004 study, and transitioned through the CUP, NPP or EAP
- Participant is on vamorolone on the day of enrolment
- Participant and parent / legal guardian are willing and able to comply with the protocol schedule, assessments and requirements
Age in the registry: - to 17 years · Sex: Male · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universiteit Gent | Gent | Belgium | Active, not recruiting |
| UZ Leuven | Leuven | Belgium | Active, not recruiting |
| Fakultni Nemocnice Brno | Brno-Sever | Czechia | Active, not recruiting |
| Fakultni Nemocnice Motol a Homolka | Prague | Czechia | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Active, not recruiting |
| Nosokomeio Paidon I Agia Sofia | Athens | Greece | Active, not recruiting |
| Children's Health Ireland | Dublin 1 | Ireland | Active, not recruiting |
| Children's Health Ireland | Dublin 24 | Ireland | Active, not recruiting |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | Active, not recruiting |
| Radboud universitair medisch centrum Stichting | Nijmegen | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.