Phase-2 Trial of 5mg/kg/Week Prednisolone in Young Boys With DMD
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The hypothesis tested here is that a lower dose of intermittent oral corticosteroids (5mg/kg/week) will be equally effective to the 10mg/kg/week dose.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 1 month
Maximum Age: 2
Healthy Volunteers: f
View:
• Subjects ages 1 month through 30 months
• Weakness consistent with Duchenne on exam, creatine kinase ≥ 20 times the upper limit of normal, and genetic mutation known to be causative for DMD.
Locations
United States
Illinois
Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Nationwide Children's Hospital
RECRUITING
Columbus
Texas
University of Texas Southwestern
NOT_YET_RECRUITING
Dallas
Contact Information
Primary
Sara Marshall
sara.adamczak@nationwidechildrens.org
614-355-3508
Backup
Kevin Warf
kevin.warf@nationwidechildrens.org
614-355-2765
Time Frame
Start Date: 2021-04-30
Estimated Completion Date: 2026-12
Participants
Target number of participants: 26
Treatments
Experimental: Experimental
This is a one-arm study and the group of subjects are all experimental and will receive drug.
Related Therapeutic Areas
Sponsors
Collaborators: Virginia Commonwealth University, University of Texas, Children's Hospital Medical Center, Cincinnati, Ann & Robert H Lurie Children's Hospital of Chicago, Muscular Dystrophy Association
Leads: Anne M. Connolly