An interventional study of Alternate-day prednisolone and Intermittent prednisolone in Duchenne Muscular Dystrophy, sponsored by Muhammad Aamir Latif. Not yet recruiting at 1 site in Pakistan. Open to male participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Muhammad Aamir Latif · Not applicable, Interventional, and Treatment
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.
The study will provide evidence to support the standardization of corticosteroid therapy in the local population. By directly comparing alternate-day versus intermittent dosing at The University of Child Health Sciences \& Children's Hospital, Lahore, the study aims to identify the regimen that best preserves motor function while minimizing debilitating side effects, thereby improving overall quality of life and treatment compliance among local patients with Duchenne Muscular Dystrophy (DMD).
481 studies on the registry are indexed under Muscular Dystrophy, Duchenne; 108 are open to participants now.
This study's planned enrollment of 40 is above the median of 26 across 332 interventional studies indexed under Muscular Dystrophy, Duchenne.
Browse Muscular Dystrophy, Duchenne studies →Muhammad Aamir Latif is the lead sponsor of 57 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Patients will be given alternate-day administration of prednisolone at a dose of 0.75 mg/kg/day.
Drug: Alternate-day 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.
Drug: Intermittent prednisolone
Patients will be given alternate-day administration of prednisolone at a dose of 0.75 mg/kg/day.
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.
Treatment efficacy
Increase in the post-treatment North Star Ambulatory Assessment (NSAA) scores will be noted.
Time frame: 6 month after start of treatment
Weight gain
The frequency of patients who will gain weight as an adverse effect, will be noted
Time frame: 6 month after start of treatment
Hyperglycemia
The frequency of patients who will who will develop hyperglycemia as an adverse effect will be noted.
Time frame: 6 month after start of treatment
Plan to share: No — Data can be shared on a reasonable request.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
Of 45 non-industry interventional studies with no phase under Muscular Dystrophy, Duchenne, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 44. This study's planned 6 months is below that.
Counting every sponsor, half of 47 studies reached it within 20 months; a quarter within 10 and three quarters within 44.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Muscular Dystrophy, Duchenne →
Muhammad Aamir Latif