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Corticosteroid

Twice weekly glucocorticoid with or without exercise for Duchenne Muscular Dystrophy

Phase 2

Recruiting

Led By Tanja Taivassalo, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of DMD confirmed by clinical history, physical examination, elevated serum creatine kinase level, absence of dystrophin expression, and/or DNA confirmation of dystrophin mutation

Age 5.0 to 9 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 12 months

Awards & highlights

Study Summary

This trial will study if low doses of prednisone given less often and exercise training can help boys with Duchenne muscular dystrophy.

Who is the study for?

Boys aged 5 to 9 with confirmed Duchenne muscular dystrophy (DMD) who can walk at least 100 meters and climb stairs without help. They must not have been on steroids for the past six months or be on a stable steroid regimen if participating in different parts of the trial. Those with unstable medical conditions, severe heart issues, behavioral problems that affect testing cooperation, or other muscle-impacting diseases cannot join.Check my eligibility

What is being tested?

The study is testing low dose prednisone given twice weekly combined with exercise training against the standard daily prednisone treatment for DMD. The goal is to see if this new approach slows disease progression and improves muscle strength without causing significant side effects.See study design

What are the potential side effects?

While daily prednisone use is known to cause adverse effects like weight gain, bone thinning, and high blood pressure, this trial aims to determine if a lower frequency dosage reduces these risks. Exercise may pose fatigue or strain but is considered beneficial when properly monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with DMD based on tests and physical exams.

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I am between 5 and 9 years old.

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I was able to walk on my own during my first visit.

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I have not received any gastric cancer treatment before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in BMI

Trial Design

3Treatment groups

Active Control

Group I: Daily Glucocorticoid (GC)Active Control1 Intervention

Existing data from age-matched, ambulatory, on daily GC therapy, and similar exclusion criteria will be selected from the ImagingDMD database to serve as a historical control.

Group II: Twice weekly glucocorticoid with or without exerciseActive Control1 Intervention

Patients will be randomized to one of 2 groups: Twice weekly prednisone alone for 12 months Twice weekly prednisone for 6 months followed by twice weekly prednisone plus 6 months of structured, supervised and home-based exercise training.

Group III: Daily glucocorticoid with exerciseActive Control3 Interventions

Patients on daily glucocorticoids will undergo 6 months of structured, supervised and home-based exercise training.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandFED

285 Previous Clinical Trials

245,070 Total Patients Enrolled

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,568 Total Patients Enrolled

Tanja Taivassalo, MDPrincipal InvestigatorUniversity of Florida

Media Library

Prednisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04322357 — Phase 2

Duchenne Muscular Dystrophy Research Study Groups: Daily Glucocorticoid (GC), Twice weekly glucocorticoid with or without exercise, Daily glucocorticoid with exercise

Duchenne Muscular Dystrophy Clinical Trial 2023: Prednisone Highlights & Side Effects. Trial Name: NCT04322357 — Phase 2

Prednisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04322357 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions is WeekEnd Glucocorticoid with No Exercise routinely employed for?

"WeekEnd Glucocorticoid with No Exercise is a popularly prescribed medication for thyroiditis, but has also been known to effectively treat conditions such as ulcerative colitis, malignant neoplasms and varicella-zoster virus acute retinal necrosis."

Answered by AI

What qualifications are required for potential participants of this clinical trial?

"Patients with Becker Muscular dystrophy aged 5-8 years are eligible for this trial, which is currently enrolling approximately 89 participants."

Answered by AI

Has the WeekEnd Glucocorticoid with No Exercise regimen been given regulatory approval?

"Our safety assessment of WeekEnd Glucocorticoid with No Exercise scored a 2, as this Phase 2 trial has some evidence that the medication is safe but no data to support its effectiveness."

Answered by AI

Does the eligibility criteria for this medical study extend to individuals over 75 years old?

"The minimal age for recruitment into this trial is 5, with an upper limit of 8."

Answered by AI

Is this experiment actively looking for participants at the moment?

"The data contained on clinicaltrials.gov reveals that this research effort is still actively recruiting patients, with its original posting occurring on July 30th 2020 and the most recent edit taking place February 28th 2022."

Answered by AI

What is the current sample size of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that recruitment for this research is ongoing; it was initially submitted on July 30th 2020 and most recently updated on February 28th 2022. In total, 89 participants are required to be recruited from a single site."

Answered by AI

What have been the outcomes of prior investigations into WeekEnd Glucocorticoid with No Exercise?

"At present, there are 334 active clinical studies for WeekEnd Glucocorticoid with No Exercise; 92 of which have reached Phase 3. While the majority of these trials can be found in Duarte, California, they span 16403 sites worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Twice Weekly Steroids and Exercise as Therapy for DMD

2020. "Twice Weekly Steroids and Exercise as Therapy for DMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04322357.

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