At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 54 enrolled
Drug / intervention
Vamorolonedrug
Likely dose
Not stated in 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 II Open-Label, Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)
In Brief
A Phase 2 clinical trial evaluating Vamorolone for Duchenne Muscular Dystrophy. Completed, enrolled 54 participants across 5 sites.
Detailed Summary
This Phase II study is an open-label, multiple dose study to evaluate the safety, tolerability, PK, PD, clinical efficacy, behavior and neuropsychology, and physical functioning vamorolone over a treatment period of 12 weeks in steroid-naïve boys ages 2 to \<4 years, and glucocorticoid-treated and currently untreated boys ages 7 to \<18 years with DMD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedJan 2022
Enrollment StartMar 2022
Primary CompletionJul 2024
TodayJul 2026
First PostedJan 11, 2022
Enrollment StartMar 21, 2022
Primary CompletionJul 16, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.5 years ago
Interventions
Vamorolonedrug
Oral administration of vamorolone for 12 weeks.