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Recruiting Phase 4 NCT05412394

Once Weekly Infant Corticosteroid Trial for DMD

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Trial Parameters

Condition Duchenne Muscular Dystrophy
Sponsor Anne M. Connolly
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 26
Sex MALE
Min Age 1 Month
Max Age 30 Months
Start Date 2021-04-30
Completion 2026-08
Interventions
Prednisolone

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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.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * Prior treatment with Glucocorticosteroids

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