Trial | NCT00541164  Report issue

Title

Effects of Coenzyme Q10 on Charcot-Marie-Tooth Disease
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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ubiquinone ...

  • Study Participants

    23
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.
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 Started
Sep 30
2007
Primary Completion
Jan 31
2013
Study Completion
Jan 31
2013
Last Update
Jul 15
2013
Estimate

Drug Coenzyme Q10

300 mg CoQ10 twice a day for 48 weeks

  • Other names: CoQ10, Ubiquinone

Dietary Supplement Coenzyme Q10

300mg CoQ10 twice a day for 24 weeks beginning at week 24 of the study

  • Other names: Ubiquinone, CoQ10

1 Experimental

300 mg CoQ10 chewable wafer twice a day

2 Placebo Comparator

Chewable placebo wafer twice a day for 24 weeks with crossover to 300mg CoQ10 twice a day for weeks 24-48.

Criteria 

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
No Results Posted