Effects of Coenzyme Q10 on Charcot-Marie-Tooth Disease
|Charcot Marie Tooth Disease||Drug: Coenzyme Q10 Dietary Supplement: Coenzyme Q10||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||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|
- 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 ]
- Improvements in quality of life in subjects with CMT before and after CoQ10 supplementation. [ Time Frame: 60 weeks ]
- Measure blood serum levels of the oxidized and reduced forms of CoQ10. [ Time Frame: 60 weeks ]
- Measure liver function tests [ Time Frame: visits 1, 6, 12 ]
|Study Start Date:||September 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
300 mg CoQ10 chewable wafer twice a day
Drug: Coenzyme Q10
300 mg CoQ10 twice a day for 48 weeks
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541164
|United States, Pennsylvania|
|John P Murtha Neuroscience and Pain Institute|
|Johnstown, Pennsylvania, United States, 15904|
|Principal Investigator:||Sharon Plank, MD||John P. Murtha Neuroscience and Pain Institute|