RECRUITING
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Once Weekly Infant Corticosteroid Trial for DMD
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 Start (Actual) 30 April 2021
🗓️ Primary Completion (Estimated) 30 August 2026
✅ Study Completion (Estimated) 30 December 2026
👥 Enrollment (Estimated) 26
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Chicago, Illinois, United States
📍 Cincinnati, Ohio, United States
📍 Columbus, Ohio, United States
📍 Dallas, Texas, United States
📍 Richmond, Virginia, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 1 Month to 30 Months (CHILD)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 2 February 2022
  • First Submitted that Met QC Criteria 7 June 2022
  • First Posted 9 June 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 September 2023
  • Last Update Posted 18 September 2023
  • Last Verified September 2023
I'm interested ...!!