121
Participants
Start Date
June 29, 2018
Primary Completion Date
February 23, 2021
Study Completion Date
August 19, 2021
Vamorolone
Oral administration of 2.0 mg/kg/day for the duration of the study.
Prednisone
Oral administration of 0.75 mg/kg/day for 24 weeks.
Placebo
Oral administration of placebo daily for 24 weeks.
Vamorolone
Oral administration of 6.0 mg/kg/day for the duration of the study.
Prednisone
Oral administration of 0.75 mg/kg/day for 24 weeks.
Placebo
Oral administration of placebo daily for 24 weeks.
Vamorolone
Oral administration of 2.0 mg/kg/day for 20 weeks.
Vamorolone
Oral administration of 6.0 mg/kg/day for 20 weeks.
Children's Hospital of Virginia of Virginia Commonwealth University, Richmond
Duke Children's Hospital, Durham
Nemours Children's Hospital, Orlando
Queen Silvia Children's Hospital, Gothenburg
Schneider Children's Medical Center, Petah Tikvah
Gillette Children's Speciality Health Care, Saint Paul
Ann & Robert H. Lurie Children's Hospital, Chicago
University of Texas Southwestern Medical Center, Dallas
Children's Hospital Colorado, Aurora
University of California Los Angeles, Los Angeles
University of California Davis, Davis
Seattle Children's Hospital, Seattle
Royal Children's Hospital, Melbourne
Sydney Children's Hospital, Westmead
Ghent University Hospital, Ghent
University Hospitals Leuven, Leuven
University Hospital Brno, Brno
Charles University, Prague
Agia Sofia Children's Hospital, Athens
Leiden University Medical Center, Leiden
Radboud University, Nijmegen
Sant Joan de Deu Hospital - Barcelona, Spain, Barcelona
Hospital Universitario y Politécnico La Fe, Valencia
Birmingham Heartlands Hospital, Birmingham
Leeds Teaching Hospital Trust, Leeds
Great Ormond Street Hospital, London
Alberta's Children Hospital, Calgary
British Columbia Children's Hospital, Vancouver
Children's Hospital of Eastern Ontario, Ottawa
Montreal Children's Hospital, Montreal
Royal Hospital for Children, Glasgow
Alder Hey Children's NHS Foundation Trust, Liverpool
Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne
European Union
OTHER
Cooperative International Neuromuscular Research Group
NETWORK
Newcastle University
OTHER
University of Pittsburgh
OTHER
ReveraGen BioPharma, Inc.
INDUSTRY