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NCT04054375 · ClinicalTrials.gov registry record · Phase 2
Weekly Steroids in Muscular Dystrophy
A Phase 2 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04054375: Completed Phase 2 study, sponsored by Northwestern University.
NCT04054375 is a Phase 2 study that has completed, run by Northwestern University. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04054375, a Phase 2 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of oral weekly glucocorticoid steroids in patients with Becker Muscular Dystrophy (BMD), an inherited disorder in which patients experience weakness of the legs and pelvis, and Limb Girdle Muscular Dystrophy (LGMD), an inherited disorder in which patients experience progressive muscular weakness predominately in their hip and shoulders. The primary objective is safety which we the investigators will measure using laboratory testing and forced vital capacity (FVC), a breathing test that measures the strength of your lungs. The secondary objective is efficacy which will be measured by a change in MRI muscle mass, improved muscle performance, and quality of life. The investigators hypothesize that patients who receive oral weekly glucocorticoid steroids will have improviements in strength and quality of life compared to their baseline. Furthermore, the investigators anticipate that oral weekly glucocorticoid steroids will not have significant adverse impact on patients.
Primary Outcome
mg/dL, 0-unlimited, higher score indicates worse outcome
Interventions
- DRUG Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2022-03-01 |
| Phase | Phase 2 |
What the finished NCT04054375 record still lists
NCT04054375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Prednisone is the first listed.
NCT04054375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04054375 about?
NCT04054375 is a clinical study titled "Weekly Steroids in Muscular Dystrophy". The purpose of this study is to evaluate the safety and efficacy of oral weekly glucocorticoid steroids in patients with Becker Muscular Dystrophy (BMD), an inherited disorder in which patients experience weakness of the legs and pelvis, and Limb Girdle Muscular Dystrophy (LGMD), an inherited disord...
What is the current status of trial NCT04054375?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2019-07-01. Estimated completion is 2022-03-01.
What interventions are being tested in trial NCT04054375?
The interventions under investigation include: Prednisone (DRUG).
Who is sponsoring clinical trial NCT04054375?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04054375's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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