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.
Who can participate
SexMALE
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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
What they're measuring
1
Number of vertebral fractures per 1000 person-years based on X-ray central reading.
Timeframe: At Enrolment and every 2 years during a Full visit