Status:
AVAILABLE
Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy
Lead Sponsor:
Santhera Pharmaceuticals
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
Brief Summary
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 ther...
Detailed Description
Vamorolone will be shipped to the subject's family by the study site. The patient will receive standard of care treatment and procedures for management of DMD. Treating Physicians participating in the...
Eligibility Criteria
Inclusion
- Subject's parent or legal guardian has provided written informed consent/HIPAA authorization
- Subject has previously completed at a participating US or Canada study site VBP15-LTE up to and including the Month 24 assessments, OR VBP15-004 up to and including the Week 48 assessments, VBP15-006 up to and including the Week 12 assessment
- Subject and parent/guardian are willing and able to comply with recommended study drug administration plan, and standard of care follow-up and monitoring as recommended by their Treating Physician
Exclusion
- Subject had a serious or severe adverse event in study VBP15-LTE or VBP15-004 or VBP15-006 that, in the opinion of the Treating Physician and Sponsor, was probably or definitely related to vamorolone use and precludes safe use of vamorolone for the subject in this expanded access program
- Subject and/or parent/guardian are unable and/or unwilling to comply with regular medical care and follow-up as recommended by their Treating Physician throughout participation in the VBP15-EAP
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03863119
Last Update
September 30 2025
Active Locations (11)
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1
University of California Davis
Davis, California, United States, 95616
2
Nemours Children's Hospital
Orlando, Florida, United States, 32827
3
urie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
4
Duke University
Durham, North Carolina, United States, 27710