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NCT05412394 · ClinicalTrials.gov registry record · Phase 4
Once Weekly Infant Corticosteroid Trial for DMD
A Phase 4 study of Duchenne Muscular Dystrophy, sponsored by Anne M. Connolly.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
- 4
- Study locations
NCT05412394: Recruiting Phase 4 study of Duchenne Muscular Dystrophy, sponsored by Anne M. Connolly.
NCT05412394 is a Phase 4 study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by Anne M. Connolly. The registered enrollment target is 26 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05412394, a Phase 4 study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by Anne M. Connolly.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
- 4
- Study locations
Study Summary
The hypothesis tested here is that a lower dose of intermittent oral corticosteroids (5mg/kg/week) will be equally effective to the 10mg/kg/week dose.
Primary Outcome
Neuromuscular Gross Motor Outcome (GRO): The Neuromuscular GRO is a gross motor outcome measure developed to assess whole body strength, motor development, and function for all levels of ability across the lifespan in those diagnosed with neuromuscular disease. Items are administered following the developmental sequence, as appropriate for age and ability. Maximum score is 100 points.
Conditions Studied
Interventions
- DRUG Prednisolone
Study Locations (4)
Ohio
- University of Cincinnati - Cincinnati
- Nationwide Children's Hospital - Columbus
Illinois
- Lurie Children's Hospital of Chicago - Chicago
Texas
- University of Texas Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What NCT05412394 shows while recruiting
NCT05412394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which Prednisolone is the first listed.
NCT05412394 reports a single indexed study location in Ohio, Illinois, Texas.
Frequently Asked Questions
What is clinical trial NCT05412394 about?
NCT05412394 is a clinical study titled "Once Weekly Infant Corticosteroid Trial for DMD". The hypothesis tested here is that a lower dose of intermittent oral corticosteroids (5mg/kg/week) will be equally effective to the 10mg/kg/week dose.
What is the current status of trial NCT05412394?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2021-04-30. Estimated completion is 2026-12.
What conditions does trial NCT05412394 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT05412394?
The interventions under investigation include: Prednisolone (DRUG).
Who is sponsoring clinical trial NCT05412394?
This trial is sponsored by Anne M. Connolly, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05412394 being conducted?
This trial has 4 study locations across Illinois, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Duchenne Muscular Dystrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05412394's enrollment target sits among peer trials
26 33rd of 48 higher than 15 of 48 other Duchenne Muscular Dystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Duchenne Muscular Dystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502)
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AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
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A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
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Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients
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The Duchenne Registry
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