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The goals of this trial are to determine if coenzyme Q10 is effective in slowing the worsening symptoms of Huntington's disease and to learn about the safety and acceptability of long-term coenzyme Q10 use by determining its effects on people with Huntington's disease.
Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available. The purpose of this trial is to find out if coenzyme Q10 (CoQ) is effective in slowing the worsening symptoms of HD. In this study, researchers also will learn about the safety and acceptability of long-term CoQ use by determining its effects on people with HD. Participants in this trial will be randomly chosen to one of two groups. Group 1 will receive CoQ (2400 mg/day), and group 2 will receive a placebo (an inactive substance). Researchers will compare the change in total functional capacity (TFC)-a measure of functional disability-in the two groups. The TFC is a valid and reliable measure of disease progression and is particularly responsive to change in the early and mid-stages of HD. Researchers will also compare the changes in other components of the Unified Huntington's Disease Rating Scale '99 (UHDRS) including: the total motor score, total behavioral frequency score, total behavior frequency X severity score, verbal fluency test, symbol digit modalities test, Stroop, interference test, functional checklist, and independence scale scores. The groups will also be compared with respect to tolerability, adverse events, vital signs, and laboratory test results as measures of safety.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama At Birmingham, Pediatric Neurology Childrens, Harbor Bldg Suite 314, 1600 7Th Avenue South
Birmingham, Alabama, United States
Mayo Clinic Arizona, 13400 East Shea Boulevard, Csu-Cp21B
Scottsdale, Arizona, United States
WASHINGTON REGIONAL MEDICAL CENTER, 3215 N. North Hills Blvd
Fayetteville, Arkansas, United States
University of California Irvine, Department of Neurology, 100 Irvine Hall
Irvine, California, United States
University of California Davis, Medical Center Dept of Neurology, Acc Building Suite 3700, 4860 Y Street
Sacramento, California, United States
Colorado Neurological Institute, Movement Disorders Center, 701 East Hampden Avenue Suite 510
Littleton, Colorado, United States
University of Florida Center for Movement Disorders and Neurorestoration, 3450 Hull Road, 4th Floor
Gainesville, Florida, United States
UNIVERSITY OF MIAMI, 1150 NW 14th STREET, #401
Miami, Florida, United States
University of South Florida, College of Medicine Dept of Neurology, 12901 Bruce B Downs Blvd Mdc-55
Tampa, Florida, United States
Emory University, Wesley Woods Center, 1841 Clifton Road NE Room 314
Atlanta, Georgia, United States
Start Date
March 1, 2008
Primary Completion Date
November 1, 2014
Completion Date
May 1, 2015
Last Updated
March 30, 2016
609
ACTUAL participants
coenzyme Q10
DRUG
placebo
OTHER
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT02855476
NCT04120493
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05107128