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NCT04322357 · ClinicalTrials.gov registry record · Phase 2
Twice Weekly Steroids and Exercise as Therapy for DMD
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT04322357: Completed Phase 2 study, sponsored by University of Florida.
NCT04322357 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04322357, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
Participant body mass index change (weight and height will be combined to report BMI in kg/m\^2) over the course of one year
Interventions
- DRUG Prednisone
- BEHAVIORAL Exercise Training on standard steroid regimen
- DRUG Exercise training on twice-weekly steroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-07-30 |
| Est. Completion | 2025-09-04 |
| Phase | Phase 2 |
What the finished NCT04322357 record still lists
NCT04322357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT04322357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04322357 about?
NCT04322357 is a clinical study titled "Twice Weekly Steroids and Exercise as Therapy for DMD". 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 associ...
What is the current status of trial NCT04322357?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2020-07-30. Estimated completion is 2025-09-04.
What interventions are being tested in trial NCT04322357?
The interventions under investigation include: Prednisone (DRUG), Exercise Training on standard steroid regimen (BEHAVIORAL), Exercise training on twice-weekly steroids (DRUG).
Who is sponsoring clinical trial NCT04322357?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04322357's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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