Status:
RECRUITING
Once Weekly Infant Corticosteroid Trial for DMD
Lead Sponsor:
Anne M. Connolly
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Muscular Dystrophy Association
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
1-30 years
Phase:
PHASE4
Brief 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.
Detailed Description
The investigators know that the muscle destruction from Duchenne muscular dystrophy (DMD) begins in infancy and we previously demonstrated that motor decline in infancy compared to typically developin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Prior treatment with Glucocorticosteroids
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05412394
Start Date
April 30 2021
End Date
December 1 2026
Last Update
August 13 2025
Active Locations (4)
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1
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
University of Cincinnati
Cincinnati, Ohio, United States, 45220
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
4
University of Texas Southwestern
Dallas, Texas, United States, 75235