At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
Vamorolone 0.25 mg/kg/day +3 moredrug
Likely dose
Vamorolone 0.25 mg/kg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIa Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
In Brief
A Phase 2 clinical trial evaluating Vamorolone 0.25 mg/kg/day, Vamorolone 0.75 mg/kg/day, and 2 other interventions for Duchenne Muscular Dystrophy. Completed, enrolled 48 participants across 12 sites in 6 countries.
Detailed Summary
The purpose of this study is to determine whether a new medication called vamorolone is safe and well-tolerated by boys with Duchenne muscular dystrophy (DMD) ages ≥ 4 and \< 7 years old.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesAustralia, Canada, Israel, Sweden, United Kingdom, United States
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJun 2016
Primary CompletionMay 2018
TodayJul 2026
First PostedMay 3, 2016
Enrollment StartJun 1, 2016
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.2 years ago
Interventions
Vamorolone 0.25 mg/kg/daydrug
Oral administration of 0.25 mg/kg/day daily for 14 days.
Vamorolone 0.75 mg/kg/daydrug
Oral administration of 0.75 mg/kg/day daily for 14 days.
Vamorolone 2.0 mg/kg/daydrug
Oral administration of 2.0 mg/kg/day daily for 14 days.
Vamorolone 6.0 mg/kg/daydrug
Oral administration of 6 mg/kg/day daily for 14 days.