Effects of Coenzyme Q10 on Charcot-Marie-Tooth Disease

July 11, 2013 updated by: Memorial Medical Center

Effects of Coenzyme Q10 (CoQ10) on Subjects With Charcot-Marie-Tooth Disease (CMT):A Double Blind, Randomized, Controlled Trial With an Open Label Follow-up Study

The object of this research is to test the effectiveness of Coenzyme Q10 (CoQ10) on symptoms of weakness, fatigue, and pain in persons with Charcot-Marie-Tooth disease (CMT).In this study we also intend to examine the impact of daily supplementation on overall quality of life.We are also interested in identifying any differences in serum ratios of CoQ10 in the oxidized and reduced forms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CoQ10 is an integral part of the electron transport chain in the mitochondria, or the energy production centers of cells. Within recent years, there has been expanding interest in the potential benefits of CoQ10 supplementation on a variety of neuromuscular diseases, some of which involve mitochondrial dysfunction, such as CMT. Daily supplementation may have cytoprotective and neuroprotective properties, which may improve symptoms of weakness, fatigue, and pain, as well as increase quality of life (QOL) among persons with CMT.

With regards to within group comparisons we hypothesize that daily supplementation of CoQ10 taken as a 300 milligram wafer twice a day for 3 months will produce a statistically significant reduction in weakness, fatigue, and pain, along with a significant improvement in QOL as indicated from scores in both standardized physiological and scale measures.

The addition of serum level analysis will help to contextualize clinical results. We hypothesize the ratios of the oxidized and reduced forms of CoQ10 will be modified upon supplementation.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Johnstown, Pennsylvania, United States, 15904
        • John P Murtha Neuroscience and Pain Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have a diagnosis of CMT, confirmed by review of medical records by the study physician
  • Subjects can be of either gender
  • Subjects must be between the ages of 18 and 75
  • Subjects must be able to complete all assessments at the designated time intervals
  • Subjects must review and sign the informed consent statement according to Conemaugh Memorial Medical Center's (CMMC) Institutional Review Board (IRB) guidelines
  • Subjects must receive approval from their primary care physician (PCP) to enroll in the study
  • Regarding weakness, fatigue, and pain, subjects must experience at least two of the three symptoms on most days over the past month
  • Regarding weakness, fatigue, and pain, subjects must report experiencing maximum levels of >/= 3.0 centimeters (cm) on the 10 cm visual analog scale (VAS) for any two of the three symptoms over the past month
  • Female subjects must be willing to practice stable birth control during involvement in the study
  • Subjects must agree to be randomized

Exclusion Criteria:

  • Subjects having another general medical condition, which might confound the assessment of weakness, fatigue, and pain due to CMT
  • Subjects taking warfarin or Coumadin
  • Subjects who are pregnant, verified by a urine pregnancy test*
  • Subjects having a cognitive impairment scoring < 20 on the Mini-Mental State Exam
  • Subjects who are currently using CoQ10 supplementation or have used it in the past 6 months
  • Subjects with a history of chronic liver disease or other condition causing malabsorption
  • Drug intake that could modify lipid absorption (such as statins)
  • Subjects who consume >3 alcoholic drinks per day on more than one occasion per month

  • Subjects with abnormal liver function tests as defined through a Hepatic -Function Panel or a Liver Function Panel

    • Women of childbearing age who have had at least one menstrual cycle within the past 12 months and who have not undergone a sterilization procedure will undergo a urine pregnancy test at visits 1-10 regardless of group assignment in order to maintain the single blind. The urine samples will be processed at CMMC's lab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
300 mg CoQ10 chewable wafer twice a day
Drug: Coenzyme Q10
300 mg CoQ10 twice a day for 48 weeks
Other Names:
  • CoQ10
  • Ubiquinone
Placebo Comparator: 2
Chewable placebo wafer twice a day for 24 weeks with crossover to 300mg CoQ10 twice a day for weeks 24-48.
Dietary supplement: Coenzyme Q10
300mg CoQ10 twice a day for 24 weeks beginning at week 24 of the study
Other Names:
  • CoQ10
  • Ubiquinone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in weakness, fatigue and pain in persons with Charcot-Marie-Tooth disease after supplementation with 600 mgs a day of Coenzyme Q10.
Time Frame: 60 weeks
60 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvements in quality of life in subjects with CMT before and after CoQ10 supplementation.
Time Frame: 60 weeks
60 weeks
Measure blood serum levels of the oxidized and reduced forms of CoQ10.
Time Frame: 60 weeks
60 weeks
Measure liver function tests
Time Frame: visits 1, 6, 12
visits 1, 6, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Medical Center

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Sharon Plank, MD, John P. Murtha Neuroscience and Pain Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 9, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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