At a glance
ClinicalIndex Comparison Record- ✓Subject has previously completed study VBP15-003 up to and including the Week 24 Final assessments, prior to enrolling in the VBP15-LTE study at the conclusion of the VBP15-003 Week 24 Visit (or within 8 weeks after dose-tapering).
- ✓Subject and parent/guardian are willing and able to comply with scheduled visits, study drug administration, and study procedures.
- ✕Subject had a serious or severe adverse event in VBP15-003 that was probably or definitely related to vamorolone and precludes safe use.
- ✕Subject has current or history of major renal or hepatic impairment, diabetes mellitus, or immunosuppression.
- ✕Subject has current or history of chronic systemic fungal or viral infections.
- ✕Subject has used mineralocorticoid receptor agents (spironolactone, eplerenone, canrenone, prorenone, mexrenone) within 4 weeks prior to first dose.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 24-month Phase II Open-label, Multicenter Long-term Extension Study to Assess the Long-Term Safety and Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
In Brief
A Phase 2 clinical trial evaluating Vamorolone 0.25 mg/day/day, Vamorolone 0.75 mg/day/day, and 2 other interventions for Duchenne Muscular Dystrophy. Completed, enrolled 46 participants across 12 sites in 6 countries.
Detailed Summary
This long-term extension study is an open-label, multiple-dose study to evaluate the long-term safety, tolerability, efficacy and PD of vamorolone administered once daily by liquid oral suspension over a Treatment Period of 24 months to young boys with DMD who participated in the VBP15-002 Phase IIa and VBP15-003 Phase IIa extension core studies.
Study Details
Timeline
Interventions
Oral administration of 0.25 mg/kg/day daily for 24 months.
Oral administration of 0.75 mg/kg/day daily for 24 months.
Oral administration of 2.0 mg/kg/day daily for 24 months.
Oral administration of 6.0 mg/kg/day daily for 24 months.