RecruitingPhase 4NCT05412394
Once Weekly Infant Corticosteroid Trial for DMD
Phase-2 Trial of 5mg/kg/Week Prednisolone in Young Boys With DMD
Sponsor
Anne M. Connolly
Enrollment
26 participants
Start Date
Apr 30, 2021
Study Type
INTERVENTIONAL
Conditions
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
Sex: MALEMin Age: 1 MonthMax Age: 30 Months
Inclusion Criteria2
- 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 Criteria1
- Prior treatment with Glucocorticosteroids
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Interventions
DRUGPrednisolone
Liquid, 5mg/kg per week, for one year
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05412394
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