Recruiting

Corticosteroid

Sponsor:

Anne M. Connolly

Code:

NCT05412394

Conditions

Duchenne Muscular Dystrophy

Eligibility Criteria

Sex: Male

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Prednisolone

Study Details

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.

Conditions

Duchenne Muscular Dystrophy

Study ID

NCT05412394

Start date

Apr 30, 2021

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0 - 2

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

This is a one-arm study and the group of subjects are all experimental and will receive drug.

Interventions

Prednisolone

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

Primary outcome measure

  • The change from baseline to 24 months for the Gross Motor Scaled Score. [ Time Frame: Baseline visit to 24 month visit ]

Central Contacts and Locations

Central contacts

Sara Marshall

614-355-3508sara.adamczak@nationwidechildrens.org

Kevin Warf

614-355-2765kevin.warf@nationwidechildrens.org

Locations

Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45220

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Kevin Warf, BS

(614) 355-2765kevin.warf@nationwidechildrens.org

Principal Investigator:

Anne Connolly, MD

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75235

Contacts

Shahera Ranjha, MS

214-456-5959shahera.ranjha@utsouthwestern.edu

More Information

Sponsor

Anne M. Connolly

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Duchenne Muscular Dystrophy
  • DMD
  • Steroid
  • Muscular Dystrophy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anne M. Connolly on 2026-08-14.