Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy
Recruiting at11 trial locations
Age: Any Age
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Santhera Pharmaceuticals
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The intent of this protocol is to provide continued access to vamorolone for subjects in the United States 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.
Research Team
Eligibility Criteria
Inclusion Criteria
Subject's parent or legal guardian has provided written informed consent/HIPAA authorization
Subject has previously completed at a participating US study site VBP15-LTE up to and including the Month 24 assessments, OR VBP15-004 up to and including the Week 48 assessments, within 30 days prior to participation in the VBP15-EAP
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
Treatment Details
Interventions
- Vamorolone (Corticosteroid)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Santhera Pharmaceuticals
Lead Sponsor
Trials
32
Recruited
2,800+
ReveraGen BioPharma, Inc.
Lead Sponsor
Trials
9
Recruited
440+