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NCT02167217 · ClinicalTrials.gov registry record · Phase 2
Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT02167217 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 25 participants.
The verdict
NCT02167217, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
While it has been known for many years that corticosteroid use benefits boys with Duchenne Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4 years of age. The primary reason for the delay is that daily corticosteroid use has many side effects including short stature, obesity, and osteoporosis. A recent randomized blinded study of weekend oral corticosteroid use over one year showed equal improvement in strength with fewer side effects, particularly as related to growth and cushingoid changes. The investigators will test the efficacy of oral weekend corticosteroid use in infants and young boys with DMD who are under age 30 months. The investigators have demonstrated that the Bayley-III Scales of Infant development shows that infants and young boys in this age group who are untreated decline in abilities when compared to their peers. Here, in this Phase 2 historically controlled trial, the investigators will use these two measures and treat boys at five Muscular Dystrophy Association-DMD centers
Interventions
- DRUG Prednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-04-17 |
| Est. Completion | 2017-03-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02167217
The ClinicalTrials.gov registry entry for NCT02167217 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Prednisolone is the first listed.
NCT02167217 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02167217 about?
NCT02167217 is a clinical study titled "Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy". While it has been known for many years that corticosteroid use benefits boys with Duchenne Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4 years of age. The primary reason for the delay is that daily corticosteroid use has many side effects including short s...
What is the current status of trial NCT02167217?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2014-04-17. Estimated completion is 2017-03-22.
What interventions are being tested in trial NCT02167217?
The interventions under investigation include: Prednisolone (DRUG).
Who is sponsoring clinical trial NCT02167217?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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