At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 24 enrolled

Drug / intervention

CoenzymeQ10 +1 moredrug

Likely dose

CoenzymeQ10 10 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00432744

NCT00432744Phase 3Completed

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Phase 3 Trial of Coenzyme Q10 in Mitochondrial Disease

University of Florida·interventional·Posted Feb 8, 2007·Updated Sep 11, 2017

In Brief

A Phase 3 clinical trial evaluating CoenzymeQ10 and Placebo for Mitochondrial Diseases. Completed, enrolled 24 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMitochondrial Diseases

CountriesCanada, United States

CollaboratorsFDA Office of Orphan Products Development, Food and Drug Administration (FDA)

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2007

First PostedFeb 2007

Primary CompletionMay 2013

TodayJul 2026

First PostedFeb 8, 2007

Enrollment StartJan 1, 2007

Primary CompletionMay 1, 2013

TodayJul 2, 2026

Enrollment to primary: 6.3 yearsPosted 19.4 years ago

Interventions

CoenzymeQ10drug

CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.

Placebodrug

Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.