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Intermittent vs Alternate Daily Regimen of Prednisolone in Ambulatory Boys With Duchenne Muscular Dystrophy

NCT07787689 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-26

No results posted yet for this study

Summary

The alternate-day regimen is hypothesized to reduce hypothalamic-pituitary-adrenal (HPA) axis suppression and decrease steroid-related toxicity. Similarly, intermittent regimens aim to provide periodic steroid exposure sufficient for muscle preservation while allowing recovery periods to limit side effects. There is a critical need for localized, prospective data to determine which protocol offers the optimal balance of efficacy and safety for pediatric patients in Pakistan.

Conditions

Interventions

DRUG

Alternate-day prednisolone

Patients will be given alternate-day administration of prednisolone at a dose of 0.75 mg/kg/day.

DRUG

Intermittent prednisolone

Patients will be administered prednisolone at a dose of 0.75 mg/kg/day for 10 consecutive days, followed by a 10-day steroid-free period.

Sponsors & Collaborators

  • Muhammad Aamir Latif

    lead OTHER

Principal Investigators

  • Nida Imdad · Children's Hospital/University of Child Health Sciences, Lahore

  • Tipu Sultan, FCPS · Children's Hospital/University of Child Health Sciences, Lahore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2027-03-15
Completion
2027-03-15

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

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 NCT07787689 on ClinicalTrials.gov