Actively Recruiting

Phase 4
Age: 1Month - 30Months
MALE
NCT05412394

Once Weekly Infant Corticosteroid Trial for DMD

Led by Anne M. Connolly · Updated on 2025-08-13

26

Participants Needed

4

Research Sites

291 weeks

Total Duration

On this page

Sponsors

A

Anne M. Connolly

Lead Sponsor

C

Children's Hospital Medical Center, Cincinnati

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Once Weekly Infant Corticosteroid Trial for DMD

Who Can Participate

Age: 1Month - 30Months
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects ages 1 month through 30 months
  • Weakness consistent with Duchenne muscular dystrophy on exam
  • Creatine kinase level at least 20 times the upper limit of normal
  • Genetic mutation known to cause Duchenne muscular dystrophy
Not Eligible

You will not qualify if you...

  • Prior treatment with glucocorticosteroids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

2

University of Cincinnati

Cincinnati, Ohio, United States, 45220

Actively Recruiting

3

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

4

University of Texas Southwestern

Dallas, Texas, United States, 75235

Actively Recruiting

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Research Team

S

Sara Marshall

CONTACT

K

Kevin Warf

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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