Once Weekly Infant Corticosteroid Trial for DMD

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age1-30
SponsorAnne M. Connolly

About this trial

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

Qualifiers

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.

Disqualifiers

Prior treatment with Glucocorticosteroids

Trial design

Treatments tested in this trial

  • Prednisolone

Treatment groups

26 Participants
are divided into 1 treatment group

Sponsors and collaborators

Anne M. Connolly

Lead sponsor

Nationwide Children's Hospital

Sponsor institution

Children's Hospital Medical Center, Cincinnati

Collaborator

Muscular Dystrophy Association

Collaborator

University of Texas

Collaborator

Virginia Commonwealth University

Collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator