Coenzyme Q10 in Huntington's Disease (HD)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Huntington's Disease

In brief

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.

Key facts

Study ID: NCT00608881
Run by: Massachusetts General Hospital
People needed: 609
Starts: 2008-03-01
Expected to finish: 2015-05-01
Last updated by the study team: 2016-03-30

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

To be eligible for enrollment into this study, subjects must meet the following eligibility criteria within 28 days prior to randomization:
Subjects must have clinical features of HD and a confirmed family history of HD, OR a CAG repeat expansion ≥ 36.
TFC > 9.
Must be ambulatory and not require skilled nursing care.
Age ≥ 16 years.
Women must not be able to become pregnant (e.g., post menopausal, surgically sterile or using adequate birth control methods for the duration of the study).
If psychotropic medications are taken (e.g., anxiolytics, hypnotics, benzodiazepines, antidepressants), they must be at a stable dosage for four weeks prior to randomization and should be maintained at a constant dosage throughout the study, as possible. (Note: stable dosing of tetrabenazine is allowable.) Any changes to these medications mandated by clinical conditions will be systematically recorded and the subject will be permitted to remain in the trial.
Able to give informed consent and comply with trial procedures
Able to take oral medication.
May be required to identify an informant or caregiver who will be willing and able to supervise the daily dosing of study medications and to maintain control of study medications in the home.
A designated individual will be identified by the subject to participate in the ongoing consent process should the subject's cognitive capacity to consent become compromised during participation in the study.

You may not qualify if…

History or known sensitivity of intolerability to CoQ.
Exposure to any investigational drug within 30 days of the Baseline visit.
Clinical evidence of unstable medical illness in the investigator's judgment.
Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression or suicidal ideation within 90 days of the Baseline visit.
Substance (alcohol or drug) abuse within one year of the Baseline visit.
Women who are pregnant or breastfeeding.
Use of supplemental coenzyme Q10 within 30 days prior to the Baseline visit
Clinically serious abnormalities in the screening laboratory studies (Screening creatinine greater than 2.0, alanine aminotransferase (ALT) or total bilirubin greater than 3 times the upper limit of normal, absolute neutrophil count of ≤1000/ul, platelet concentration of <100,000/ul, hematocrit level of <33 for female or <35 for male, or coagulation tests > 1.5 time upper limit of normal).
Known allergy to FD\&C yellow #5 or any other ingredient in the study drug (active and placebo)

Where it is running

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
Idaho Elks Rehabilitation Hospital, 600 North Robbins Road — Boise, Idaho, United States
Rush University Medical Center, Department of Neurological Sciences, 1725 West Harrison Suite 755 — Chicago, Illinois, United States
Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150 — Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics, 200 Hawkins Road, Room W263 General Hospital — Iowa City, Iowa, United States
University of Kansas Medical Center, Department of Neurology, 3599 Rainbow Blvd Mail Stop 2012 — Kansas City, Kansas, United States
Hereditary Neurological Disease Centre (Hndc),3223 N. Webb, Suite 4 — Wichita, Kansas, United States
University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B — Baltimore, Maryland, United States
Johns Hopkins University, 600 North Wolfe Street, Meyer 2-181 — Baltimore, Maryland, United States
Boston University School of Medicine, Department of Neurology, 715 Albany Street C329 — Boston, Massachusetts, United States
Massachusetts General Hospital, 149 13Th Street Suite 2241 — Charlestown, Massachusetts, United States
University of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine — Ann Arbor, Michigan, United States
Struthers Parkinson'S Center, 6701 Country Club Drive — Golden Valley, Minnesota, United States
Washington University School of Medicine, Box 8111, 660 South Euclid — St Louis, Missouri, United States
University of Las Vegas School of Medicine, 1707 W. Charleston Blvd, Suite 220 — Las Vegas, Nevada, United States
Cooper University Hospital — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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