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NCT00308113 · ClinicalTrials.gov registry record · Phase 3
CoQ10 and Prednisone in Non-Ambulatory DMD
A Phase 3 study, sponsored by Cooperative International Neuromuscular Research Group.
- Terminated
- Registry status
- Phase 3
- Development phase
- 3
- Enrollment target
NCT00308113 is a Phase 3 study that was terminated before completion, run by Cooperative International Neuromuscular Research Group. The registered enrollment target is 3 participants.
The verdict
NCT00308113, a Phase 3 study, was terminated before completion, sponsored by Cooperative International Neuromuscular Research Group.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study will help determine if CoQ10 and prednisone, alone and as a combination decrease the decline in cardiopulmonary and skeletal muscle function that occurs in the wheelchair confined phase of DMD. Participants who are enrolled in this study should not have taken any corticosteroids within the last six months. This is a 13-month, prospective, randomized study comparing a daily prednisone arm (0.75mg/kg/day), a CoQ10 arm (serum of greater than 2.5 ug/mL) and a combination arm (prednisone and CoQ10) with an enhanced standard of care arm in wheelchair confined males age 10 to 18 years with an established DMD diagnosis.
Interventions
- DRUG Prednisone
- DIETARY_SUPPLEMENT Coenzyme Q10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00308113
The ClinicalTrials.gov registry entry for NCT00308113 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 3 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 2 interventions - of which Prednisone is the first listed.
NCT00308113 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00308113 about?
NCT00308113 is a clinical study titled "CoQ10 and Prednisone in Non-Ambulatory DMD". This study will help determine if CoQ10 and prednisone, alone and as a combination decrease the decline in cardiopulmonary and skeletal muscle function that occurs in the wheelchair confined phase of DMD. Participants who are enrolled in this study should not have taken any corticosteroids within th...
What is the current status of trial NCT00308113?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3 participants. The study started on 2007-04. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00308113?
The interventions under investigation include: Prednisone (DRUG), Coenzyme Q10 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00308113?
This trial is sponsored by Cooperative International Neuromuscular Research Group, which has 13 total clinical trials registered on ClinicalTrials.gov.
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