CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Vamorolone 0.25 mg/day/day +3 moredrug
Likely dose
Vamorolone 0.25 mg/day/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.

Search/NCT02760277
NCT02760277Phase 2Completed
CompareCT.gov

A Phase II Open-label, Multicenter Extension Study to Assess the Long-term Safety and Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

ReveraGen BioPharma, Inc.·interventional·Posted May 3, 2016·Updated Jul 23, 2019

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 48 participants across 12 sites in 6 countries.

Detailed Summary

The main purposes of this study are to see if it is safe to use a new medication called vamorolone for more than two weeks in children with Duchenne muscular dystrophy (DMD), to see if vamorolone works for the treatment for DMD, and to see how any potential side effects compare to those seen in boys using steroids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesAustralia, Canada, Israel, Sweden, United Kingdom, United States
CollaboratorsUniversity of Pittsburgh, National Institute of Neurological Disorders and Stroke (NINDS), Cooperative International Neuromuscular Research Group, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 3, 2016
Enrollment StartJul 28, 2016
Primary CompletionApr 26, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.2 years ago

Interventions

Vamorolone 0.25 mg/day/daydrug

Oral administration of 0.25 mg/kg/day daily for 24 weeks.

Vamorolone 0.75 mg/day/daydrug

Oral administration of 0.75 mg/kg/day daily for 24 weeks.

Vamorolone 2.0 mg/day/daydrug

Oral administration of 2.0 mg/kg/day daily for 24 weeks.

Vamorolone 6.0 mg/day/daydrug

Oral administration of 6.0 mg/kg/day daily for 24 weeks.