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Corticosteroid

Weekly Prednisolone for Duchenne Muscular Dystrophy

Phase 4
Recruiting
Led By Anne Connolly, MD
Research Sponsored by Anne M. Connolly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects ages 1 month through 30 months
Weakness consistent with Duchenne on exam, creatine kinase ≥ 20 times the upper limit of normal, and genetic mutation known to be causative for DMD.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit to 24 month visit
Awards & highlights

Study Summary

This trial found that a lower dose of intermittent oral corticosteroids (5mg/kg/week) is just as effective as the 10mg/kg/week dose.

Who is the study for?
This trial is for young children from 1 month to 30 months old who show signs of Duchenne Muscular Dystrophy (DMD) on physical exams, have high levels of an enzyme called creatine kinase in their blood, and a genetic mutation known to cause DMD. Children previously treated with glucocorticosteroids can't participate.Check my eligibility
What is being tested?
The study is testing if a lower weekly dose of the corticosteroid Prednisolone (5mg/kg) is as effective as the standard higher dose (10mg/kg) for treating symptoms of Duchenne Muscular Dystrophy in infants.See study design
What are the potential side effects?
Prednisolone may cause side effects such as increased appetite, weight gain, mood changes, high blood pressure, bone weakening over time, and higher risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 1 month and 30 months old.
Select...
I have Duchenne muscular dystrophy with high creatine kinase levels and a confirmed genetic mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit to 24 month visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit to 24 month visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change from baseline to 24 months for the Gross Motor Scaled Score.
Secondary outcome measures
Language (expressive and receptive), Social and Fine Motor skills at 24 months as assessed by the Bayley-4 Scales of Infant and Toddler Development
Linear growth

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
This is a one-arm study and the group of subjects are all experimental and will receive drug.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisolone
FDA approved

Find a Location

Who is running the clinical trial?

Muscular Dystrophy AssociationOTHER
36 Previous Clinical Trials
50,405 Total Patients Enrolled
University of TexasOTHER
186 Previous Clinical Trials
142,453 Total Patients Enrolled
Virginia Commonwealth UniversityOTHER
691 Previous Clinical Trials
22,884,727 Total Patients Enrolled

Media Library

Prednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05412394 — Phase 4
Duchenne Muscular Dystrophy Research Study Groups: Experimental
Duchenne Muscular Dystrophy Clinical Trial 2023: Prednisolone Highlights & Side Effects. Trial Name: NCT05412394 — Phase 4
Prednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412394 — Phase 4

Frequently Asked Questions

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

Do I meet the qualifications for enrollment in this clinical experiment?

"This research seeks 26 children with muscular dystrophy, duchenne between 1 month of age and 30 months of age. The required criteria for eligibility include: a minimum one-month old subject, physical manifestations that are consistent with Duchenne muscular dystrophy (DMD), creatine kinase levels at least 20 times higher than the normal upper limit, and genetic mutation known to be causative for DMD."

Answered by AI

How many participants are currently engaging in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively inviting participants and was initially announced on April 30th 2021. A total of 26 individuals must be enrolled at the single site that is associated with the study."

Answered by AI

Do the potential side-effects of Prednisolone outweigh its benefits?

"Prednisolone has been approved by the relevant regulatory bodies, making it a safe and reliable option for patients. As such, our team rated its safety as 3 out of 3."

Answered by AI

Is this research endeavor open to seniors above the age of 85?

"This medical trial is recruiting infants and toddlers aged between 1 Month to 30 Months. There are 60 patients under 18 years of age, while 49 individuals over 65 have been selected for the study."

Answered by AI

Are there any available slots for participants in this ongoing experiment?

"That is accurate. According to clinicaltrials.gov, this trial was initially posted on April 30th 2021 and recently updated June 7th 2022. The research necessitates the enrollment of 26 volunteers from a single medical facility."

Answered by AI
~12 spots leftby Aug 2026