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NCT00110669 · ClinicalTrials.gov registry record · Phase 3
High-dose Prednisone in Duchenne Muscular Dystrophy
A Phase 3 study, sponsored by Cooperative International Neuromuscular Research Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
NCT00110669 is a Phase 3 study that has completed, run by Cooperative International Neuromuscular Research Group. The registered enrollment target is 64 participants.
The verdict
NCT00110669, a Phase 3 study, has completed, sponsored by Cooperative International Neuromuscular Research Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
Study Summary
This study will help to determine whether a high-dose weekly course of prednisone therapy is safer than and at least as effective as daily dose therapy for people with Duchenne muscular dystrophy (DMD). Boys who are enrolled in this study should not have taken carnitine, other amino acids, creatine, glutamine, Coenzyme Q10 or any herbal medicines within the last three months. There will be a two-visit screening to take place in one week to ensure a reproducible manual muscle test. The subject will then be randomized and put into either the daily or weekly regimen. The duration of the study is twelve 28-day treatment cycles (approximately 12 months) with follow-up visits at month one, three and then every three months.
Interventions
- DRUG Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2004-01 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00110669
The ClinicalTrials.gov registry entry for NCT00110669 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cooperative International Neuromuscular Research Group, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Prednisone is the first listed.
NCT00110669 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00110669 about?
NCT00110669 is a clinical study titled "High-dose Prednisone in Duchenne Muscular Dystrophy". This study will help to determine whether a high-dose weekly course of prednisone therapy is safer than and at least as effective as daily dose therapy for people with Duchenne muscular dystrophy (DMD). Boys who are enrolled in this study should not have taken carnitine, other amino acids, creatine,...
What is the current status of trial NCT00110669?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 2004-01. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00110669?
The interventions under investigation include: Prednisone (DRUG).
Who is sponsoring clinical trial NCT00110669?
This trial is sponsored by Cooperative International Neuromuscular Research Group, which has 13 total clinical trials registered on ClinicalTrials.gov.
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