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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: Clinical Trial Phase 3 study, sponsored by Cooperative International Neuromuscular Research Group.

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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Comparing change from baseline of mean systolic wall stress and rate-corrected mean velocity of circumferential shortening in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year. The values are obtained via an echocardiogram read locally at each site.

Interventions

  • DRUG Prednisone
  • DIETARY_SUPPLEMENT Coenzyme Q10

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2007-04
Est. Completion 2010-11
Phase Phase 3

Why NCT00308113 stopped before completion

NCT00308113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which Prednisone is the first listed.

NCT00308113 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00308113's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00308113, the US trial registry maintained by the National Library of Medicine. NCT00308113 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.