CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Prednisone +2 moredrug
Likely dose
Prednisone 0.75 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04322357
NCT04322357Phase 2Completed

Impact and Interplay of Corticosteroid Regimen and Exercise Training on DMD Muscle Function

University of Florida·interventional·Posted Mar 26, 2020·Updated Mar 13, 2026

In Brief

A Phase 2 clinical trial evaluating Prednisone, Exercise Training on standard steroid regimen, and 1 other intervention for Duchenne Muscular Dystrophy (DMD). Completed, enrolled 21 participants across 1 site.

Detailed Summary

The study team will determine the potential of low dose twice weekly prednisone and whether exercise training can synergize to delay disease progression and improve muscle strength/physical function in boys with Duchenne muscular dystrophy (DMD). Current standard of care (daily prednisone) is associated with adverse side effects. Evidence from DMD mouse models suggest that weekly dosing provides same efficacy without side effects. Appropriate exercise may also benefit but this area has not been adequately explored.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 26, 2020
Enrollment StartJul 30, 2020
Primary CompletionDec 4, 2024
Study CompletionSep 4, 2025
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.3 years ago

Interventions

Prednisonedrug

A 12-month treatment period with twice weekly, low-dose prednisone (dose of 0.75 mg/kg per day).

Exercise Training on standard steroid regimenbehavioral

For boys on current standard of care (daily glucocorticoid use), 6-months in-home, remotely supervised exercise training program involving a combination of aerobic and isometric leg strength exercises.

Exercise training on twice-weekly steroidsdrug

Twice weekly prednisone for 6 months followed by twice weekly prednisone plus exercise for 6 months.