Coenzyme Q10 in Huntington's Disease (HD)
This trial is active, not recruiting.
|Treatments||coenzyme q10, placebo|
|Sponsor||Massachusetts General Hospital|
|Collaborator||National Institute of Neurological Disorders and Stroke (NINDS)|
|Start date||March 2008|
|End date||August 2017|
|Trial size||608 participants|
|Trial identifier||NCT00608881, 2CARE 01.00, 5R01NS052619, 5U01NS052592|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||University of Alabama At Birmingham, Pediatric Neurology Childrens, Harbor Bldg Suite 314, 1600 7Th Avenue South||no longer recruiting|
|Scottsdale, AZ||Mayo Clinic Arizona, 13400 East Shea Boulevard, Csu-Cp21B||no longer recruiting|
|Fayetteville, AR||WASHINGTON REGIONAL MEDICAL CENTER, 3215 N. North Hills Blvd||no longer recruiting|
|Irvine, CA||University of California Irvine, Department of Neurology, 100 Irvine Hall||no longer recruiting|
|Sacramento, CA||University of California Davis, Medical Center Dept of Neurology, Acc Building Suite 3700, 4860 Y Street||no longer recruiting|
|Littleton, CO||Colorado Neurological Institute, Movement Disorders Center, 701 East Hampden Avenue Suite 510||no longer recruiting|
|Gainesville, FL||University of Florida Center for Movement Disorders and Neurorestoration, 3450 Hull Road, 4th Floor||no longer recruiting|
|Miami, FL||UNIVERSITY OF MIAMI, 1150 NW 14th STREET, #401||no longer recruiting|
|Tampa, FL||University of South Florida, College of Medicine Dept of Neurology, 12901 Bruce B Downs Blvd Mdc-55||no longer recruiting|
|Atlanta, GA||Emory University, Wesley Woods Center, 1841 Clifton Road NE Room 314||no longer recruiting|
|Boise, ID||Idaho Elks Rehabilitation Hospital, 600 North Robbins Road||no longer recruiting|
|Chicago, IL||Rush University Medical Center, Department of Neurological Sciences, 1725 West Harrison Suite 755||no longer recruiting|
|Indianapolis, IN||Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150||no longer recruiting|
|Iowa City, IA||University of Iowa Hospital and Clinics, 200 Hawkins Road, Room W263 General Hospital||no longer recruiting|
|Kansas City, KS||University of Kansas Medical Center, Department of Neurology, 3599 Rainbow Blvd Mail Stop 2012||no longer recruiting|
|Wichita, KS||Hereditary Neurological Disease Centre (Hndc),3223 N. Webb, Suite 4||no longer recruiting|
|Baltimore, MD||Johns Hopkins University, 600 North Wolfe Street, Meyer 2-181||no longer recruiting|
|Baltimore, MD||University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B||no longer recruiting|
|Boston, MA||Boston University School of Medicine, Department of Neurology, 715 Albany Street C329||no longer recruiting|
|Charlestown, MA||Massachusetts General Hospital, 149 13Th Street Suite 2241||no longer recruiting|
|Ann Arbor, MI||University of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine||no longer recruiting|
|Golden Valley, MN||Struthers Parkinson'S Center, 6701 Country Club Drive||no longer recruiting|
|St Louis, MO||Washington University School of Medicine, Box 8111, 660 South Euclid||no longer recruiting|
|Las Vegas, NV||University of Las Vegas School of Medicine, 1707 W. Charleston Blvd, Suite 220||no longer recruiting|
|Camden, NJ||Cooper University Hospital||no longer recruiting|
|Edison, NJ||Nj Neuroscience Institute, Jfk Medical Center, 65 James Street||no longer recruiting|
|Albany, NY||Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr||no longer recruiting|
|Manhasset, NY||North Shore-Lij Health System, 350 Community Drive Room 110, Research Institute||no longer recruiting|
|New York, NY||Columbia University, Sergievsky Center P&S Box 16, 630 West 168Th Street||no longer recruiting|
|Rochester, NY||University of Rochester, Department of Neurology, 919 Westfall Road Building C Suite 220||no longer recruiting|
|Durham, NC||Duke University, 932 Morreene Road #213||no longer recruiting|
|Winston Salem, NC||Wake Forest University, Baptist Med Center, Department of Neurology, Medical Center Boulevard||no longer recruiting|
|Cincinnati, OH||University of Cincinnati/Cincinnati Children'S Hospital, 222 Piedmont Avenue, Suite 3200||no longer recruiting|
|Columbus, OH||OHIO STATE UNIVERSITY , 2006 Kenny Road||no longer recruiting|
|Allentown, PA||ST. LUKE'S HOSPITAL, 240 Centronia Road||no longer recruiting|
|Philadelphia, PA||University of Pennsylvania, Pennsylvania Hospital Department of Neurology , 330 South 9Th Street||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh Kaufmann Medical Building, 3471 Fifth Avunue, Suite 811||no longer recruiting|
|Providence, RI||BUTLER HOSPTIAL MOVEMENT DISORDER PROGRAM, 345 Blackstone Boulevard||no longer recruiting|
|Memphis, TN||The University of Tennesee Health Science Cen, 855 Monroe Avenue, Department of Neurology, Room 415 Link Bldg||no longer recruiting|
|Dallas, TX||UN oF TEXAS SOUTHWESTERN MED CENTER DALLAS, 5323 HARRY HINES BOULEVARD H1.108||no longer recruiting|
|Houston, TX||Baylor College of Medicine, 6550 Fannin Suite 1801||no longer recruiting|
|Wentworthville, Australia||Westmead Hospital, Department of Neurology Level 1, Po Box 533||no longer recruiting|
|Calgary, Canada||University of Calgary, Heritage Medical Research Clinic, Trw Bldg 5 Floor, 3280 Hospital Dri. NW||no longer recruiting|
|Edmonton, Canada||University of Alberta, Glenrose Rehab Hosp, Movement Disorder Clinic , Rm 0601 Gleneast 10230 - 111 Avenue||no longer recruiting|
|Vancouver, Canada||Department of Medical Genetics, Ubc Hospital, Room S179-2211 Westbrook Mall||no longer recruiting|
|London, Canada||London Health Sciences Centre, University Hospital, 339 Windermere Road||no longer recruiting|
|Markham, Canada||Centre For Movement Disorders, 2780 Bur Oak Avenue||no longer recruiting|
|Toronto, Canada||North York General Hospital, 4001 Leslie Street||no longer recruiting|
|Toronto, Canada||NORTH YORK GENERAL HOSPITAL (2), 4001 Leslie Street||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Randomized to active treatment (coenzyme Q10 2400 mg/day)
Randomized to placebo
Change in total functional capacity
time frame: over 5 years
Change in other UHDRS scores; Tolerability - proportion of subjects completing the study at the assigned dosage level; Safety - frequency of adverse events; Times to decline in TFC by 2 and 3 points
time frame: duration of the trial
Male or female participants at least 16 years old.
- 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.
- 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)
|Official title||Coenzyme Q10 in Huntington's Disease (HD)|
|Principal investigator||Merit Cudkowicz, MD MSc|
|Description||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.|
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