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Phase III Trial of Coenzyme Q10 in Mitochondrial Disease

NCT00432744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-09-11

Study results available
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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.

Conditions

  • Mitochondrial Diseases

Interventions

DRUG

CoenzymeQ10

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    collaborator FED

  • Food and Drug Administration (FDA)

    collaborator FED

  • University of Florida

    lead OTHER

Principal Investigators

  • Douglas S. Kerr, MD, PhD · Case Western Reserve University

  • Ton J deGrauw, MD, PhD · Children's Hospital Medical Center, Cincinnati

  • Annette S. Feigenbaum, MD · SickKids, Toronto, Canada/University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00432744 on ClinicalTrials.gov