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Once Weekly Infant Corticosteroid Trial for DMD

NCT05412394 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-08-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Prednisolone

Liquid, 5mg/kg per week, for one year

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Muscular Dystrophy Association

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Virginia Commonwealth University

    collaborator OTHER

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • Anne M. Connolly

    lead OTHER

Principal Investigators

  • Anne Connolly, MD · Nationwide Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
30 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2026-08-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05412394 on ClinicalTrials.gov