Effects of Coenzyme Q10 on Charcot-Marie-Tooth Disease

NCT00541164 | Completed Phase 1

• 1 other identifier: 05-19
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Charcot Marie Tooth Disease

Keywords

CMT; Charcot-Marie Tooth; CoQ10; Coenzyme Q10

Outcome Measures

Primary Outcomes (1)

• Changes in weakness, fatigue and pain in persons with Charcot-Marie-Tooth disease after supplementation with 600 mgs a day of Coenzyme Q10.

  60 weeks

Secondary Outcomes (3)

• Improvements in quality of life in subjects with CMT before and after CoQ10 supplementation.

  60 weeks

• Measure blood serum levels of the oxidized and reduced forms of CoQ10.

  60 weeks

• Measure liver function tests

  visits 1, 6, 12

Study Arms (2)

1

EXPERIMENTAL

300 mg CoQ10 chewable wafer twice a day

Drug: Coenzyme Q10

2

PLACEBO COMPARATOR

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

Interventions

Coenzyme Q10 DRUG

300 mg CoQ10 twice a day for 48 weeks

Also known as: CoQ10, Ubiquinone

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

John P Murtha Neuroscience and Pain Institute

Johnstown, Pennsylvania, 15904, United States

Location

Related Publications (9)

• Hendler SS, Rorvik D, eds. PDR for Nutritional Supplements. Montvale, NJ: Thomson PDR; 2001:105-106.

  BACKGROUND

• Chaudhuri A, Behan PO. Fatigue in neurological disorders. Lancet. 2004 Mar 20;363(9413):978-88. doi: 10.1016/S0140-6736(04)15794-2.

  PMID: 15043967 BACKGROUND

• Beal MF. Coenzyme Q10 as a possible treatment for neurodegenerative diseases. Free Radic Res. 2002 Apr;36(4):455-60. doi: 10.1080/10715760290021315.

  PMID: 12069110 BACKGROUND

• Shults CW. Coenzyme Q10 in neurodegenerative diseases. Curr Med Chem. 2003 Oct;10(19):1917-21. doi: 10.2174/0929867033456882.

  PMID: 12871093 BACKGROUND

• Bhagavan HN, Chopra RK. Coenzyme Q10: absorption, tissue uptake, metabolism and pharmacokinetics. Free Radic Res. 2006 May;40(5):445-53. doi: 10.1080/10715760600617843.

  PMID: 16551570 BACKGROUND

• Shults CW, Oakes D, Kieburtz K, Beal MF, Haas R, Plumb S, Juncos JL, Nutt J, Shoulson I, Carter J, Kompoliti K, Perlmutter JS, Reich S, Stern M, Watts RL, Kurlan R, Molho E, Harrison M, Lew M; Parkinson Study Group. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Arch Neurol. 2002 Oct;59(10):1541-50. doi: 10.1001/archneur.59.10.1541.

  PMID: 12374491 BACKGROUND

• Huntington Study Group. A randomized, placebo-controlled trial of coenzyme Q10 and remacemide in Huntington's disease. Neurology. 2001 Aug 14;57(3):397-404. doi: 10.1212/wnl.57.3.397.

  PMID: 11502903 BACKGROUND

• Jones K, Hughes K, Mischley L, McKenna DJ. Coenzyme Q-10: efficacy, safety, and use. Altern Ther Health Med. 2002 May-Jun;8(3):42-55; quiz 56, 138. No abstract available.

  PMID: 12017500 BACKGROUND

• Lagendijk J, Ubbink JB, Vermaak WJ. Measurement of the ratio between the reduced and oxidized forms of coenzyme Q10 in human plasma as a possible marker of oxidative stress. J Lipid Res. 1996 Jan;37(1):67-75.

  PMID: 8820103 BACKGROUND

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease

Interventions

coenzyme Q10; Ubiquinone

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Study Officials

• Sharon Plank, MD

  John P. Murtha Neuroscience and Pain Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 10, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 15, 2013

Record last verified: 2010-06

Locations

US (1)