RECRUITING

Once Weekly Infant Corticosteroid Trial for DMD

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Conditions

Duchenne Muscular DystrophyDMDSteroidMuscular Dystrophy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase-2 Trial of 5mg/kg/Week Prednisolone in Young Boys With DMD

Quick Facts

Study Start:2021-04-30
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05412394

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 30 Months
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Subjects ages 1 month through 30 months
  2. * Weakness consistent with Duchenne on exam, creatine kinase ≥ 20 times the upper limit of normal, and genetic mutation known to be causative for DMD.
  1. * Prior treatment with Glucocorticosteroids

Contacts and Locations

Study Contact

Kevin Warf
CONTACT
614-355-2765
kevin.warf@nationwidechildrens.org
Cosob Barre
CONTACT
(614) 722-4883
cosob.barre@nationwidechildrens.org

Principal Investigator

Anne Connolly, MD
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
University of Cincinnati
Cincinnati, Ohio, 45220
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
University of Texas Southwestern
Dallas, Texas, 75235
United States
Virginia Commonwealth University
Richmond, Virginia, 23284
United States

Collaborators and Investigators

Sponsor: Anne M. Connolly

  • Anne Connolly, MD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-30
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2021-04-30
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • Duchenne Muscular Dystrophy
  • DMD
  • Steroid
  • Muscular Dystrophy

Additional Relevant MeSH Terms

  • Duchenne Muscular Dystrophy