Status: Available
Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy
The intent of this protocol is to provide continued access to vamorolone for subjects in the United States and Canada who have completed the VBP15-LTE, VBP15- 004, or VBP15-006 protocols (and are thereby ineligible to enroll in another trial of vamorolone therapy), during the time a new drug application for vamorolone is under preparation and review.
Trial details
Biological sex: MaleType: Expanded AccessSponsor: Santhera PharmaceuticalsUpdated: Jan 20, 2026Locations: 12
Eligibility criteria
Subject's parent or legal guardian has provided written informed consent/HIPAA a... [+2]
Subject had a serious or severe adverse event in study VBP15-LTE or VBP15-004 or... [+1]