MedTrace Logo

Twice Weekly Steroids and Exercise as Therapy for DMD

NCT04322357 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-03-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Duchenne Muscular Dystrophy (DMD)

Interventions

DRUG

Prednisone

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

BEHAVIORAL

Exercise Training on standard steroid regimen

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.

DRUG

Exercise training on twice-weekly steroids

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

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • University of Florida

    lead OTHER

Principal Investigators

  • Tanja Taivassalo, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2024-12-04
Completion
2025-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04322357 on ClinicalTrials.gov