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New study tracks bone safety of DMD drug vamorolone over years

NCT ID NCT06713135

Disease control Sponsor: Santhera Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows about 80 boys with Duchenne muscular dystrophy who have already taken vamorolone in earlier studies. Researchers want to see how safe the drug is over a longer time, especially its effect on bone health, like spine fractures. The boys continue taking vamorolone while doctors monitor them for side effects and fractures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Compassionate Use Program, Named Patient Program or Expanded Acess Protocol * Subject is on vamorolone on day of enrolment * Subject and parent / legal guardian are willing and able to comply with the protocol schedule, assessments and requirements Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Duchenne muscular dystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Duchenne muscular dystrophy

Contacts and locations

Locations

  • Alder Hey Children's Hospital

    Liverpool, Merseyside, L14 5AB, United Kingdom

  • Children's Health Ireland at Tallaght, Tallaght University Hospital

    Dublin, D24TN3C, Ireland

  • Children's Hospital Agia Sofia

    Athens, 115 27, Greece

  • Fakultni Nemocnice Motol

    Prague, 150 06, Czechia

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    London, WC1N 3JH, United Kingdom

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario y Politecnico de La Fe

    Valencia, 46026, Spain

  • Leeds Teaching Hospitals NHS Trust

    Leeds, West Yorkshire, LS1 3EX, United Kingdom

  • Leiden University Medical Center

    Leiden, 2333 ZA, Netherlands

  • Queen Elizabeth University Hospital

    Glasgow, Lanarkshire, United Kingdom

  • Radboud University Nijmegen

    Nijmegen, 6525 HB, Netherlands

  • Schneider Children's Medical Center

    Petah Tikva, 4920235, Israel

  • Te Wao Nui - Child Health Service, Wellington Hospital

    Wellington, 6021, New Zealand

  • The John Walton Muscular Dystrophy Research Centre

    Newcastle, NE1 3BZ, United Kingdom

  • UZ Gent (Universitair Ziekenhuis Gent)

    Ghent, 9000, Belgium

  • UZ Leuven (Universitair Ziekenhuis Leuven)

    Leuven, 3000, Belgium

  • University Hospital Brno

    Brno, Czechia

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B9 5SS, United Kingdom

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