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NCT00432744 · ClinicalTrials.gov registry record · Phase 3
Phase III Trial of Coenzyme Q10 in Mitochondrial Disease
A Phase 3 study of Mitochondrial Diseases, sponsored by University of Florida.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
- 3
- Study locations
NCT00432744: Completed Phase 3 study of Mitochondrial Diseases, sponsored by University of Florida.
NCT00432744 is a Phase 3 study of Mitochondrial Diseases that has completed, run by University of Florida. The registered enrollment target is 24 participants, below the 273-participant average among 7 other Mitochondrial Diseases trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00432744, a Phase 3 study of Mitochondrial Diseases, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
- 3
- Study locations
Study Summary
To show that oral CoQ10 is a safe and effective treatment for children with inborn errors of mitochondrial energy metabolism due to defects in specific respiratory chain (RC) complexes or mitochondrial DNA (mtDNA) mutations, and that this beneficial action is reflected in improved motor and neurobehavioral function.
Primary Outcome
The McMaster Gross Motor Function is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CoenzymeQ10
Study Locations (3)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Case Western Reserve University - Cleveland
Ontario
- Hospital for Sick Children - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT00432744 record still lists
NCT00432744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 273-participant average among 7 other Mitochondrial Diseases trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Mitochondrial Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00432744 reports a single indexed study location in Ohio, Ontario.
Frequently Asked Questions
What is clinical trial NCT00432744 about?
NCT00432744 is a clinical study titled "Phase III Trial of Coenzyme Q10 in Mitochondrial Disease". To show that oral CoQ10 is a safe and effective treatment for children with inborn errors of mitochondrial energy metabolism due to defects in specific respiratory chain (RC) complexes or mitochondrial DNA (mtDNA) mutations, and that this beneficial action is reflected in improved motor and neurobeh...
What is the current status of trial NCT00432744?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2007-01. Estimated completion is 2013-05.
What conditions does trial NCT00432744 study?
This clinical trial studies the following conditions: Mitochondrial Diseases.
What interventions are being tested in trial NCT00432744?
The interventions under investigation include: Placebo (DRUG), CoenzymeQ10 (DRUG).
Who is sponsoring clinical trial NCT00432744?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00432744 being conducted?
This trial has 3 study locations across Ohio, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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