Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

February 2, 2017

Primary Completion Date

April 30, 2020

Study Completion Date

April 30, 2020

Conditions
Duchenne Muscular Dystrophy
Interventions
DRUG

Vamorolone 0.25 mg/day/day

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

DRUG

Vamorolone 0.75 mg/day/day

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

DRUG

Vamorolone 2.0 mg/day/day

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

DRUG

Vamorolone 6.0 mg/day/day

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

Trial Locations (12)

27710

Duke University, Durham

32611

University of Florida, Gainesville

32827

Nemours Children's Hospital, Orlando

41685

Queen Silvia Children's Hospital, Gothenburg

49202

Schneider Children's Medical Center, Petah Tikva

60611

Ann & Robert H. Lurie Children's Hospital, Chicago

75207

University of Texas Southwestern Medical Center, Dallas

95616

University of California Davis, Davis

Unknown

Royal Children's Hospital, Melbourne

Sydney Children's Hospital, Westmead

T3B 6A8

Alberta Children's Hospital, Calgary

NE7 7DN

Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

All Listed Sponsors
collaborator

University of Pittsburgh

OTHER

collaborator

Cooperative International Neuromuscular Research Group

NETWORK

lead

ReveraGen BioPharma, Inc.

INDUSTRY

NCT03038399 - Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) | Biotech Hunter | Biotech Hunter