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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 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 21 participants.

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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.

Interventions

  • DRUG Prednisone
  • BEHAVIORAL Exercise Training on standard steroid regimen
  • DRUG Exercise training on twice-weekly steroids

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2020-07-30
Est. Completion 2025-09-04
Phase Phase 2

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT04322357

The ClinicalTrials.gov registry entry for NCT04322357 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.

NCT04322357 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.