Coenzyme Q10 in Huntington's Disease (HD)

Huntington's Disease Clinical Trial

— 2CARE  

Official title:

Coenzyme Q10 in Huntington's Disease (HD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00608881
• Other study ID #: 2CARE 01.00
• Secondary ID: 5U01NS0525925R01
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 4, 2008
• Last updated: November 25, 2014
• Start date: March 2008
• Est. completion date: August 2015

Study information

• Verified date: November 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 608
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Drug:
• coenzyme Q10
4 - 300 mg CoQ chewable wafers taken orally twice a day

Other:
• placebo
an inactive substance

Locations

Country	Name	City	State
Australia	Westmead Hospital, Department of Neurology Level 1, Po Box 533	Wentworthville	New South Wales
Canada	University of Calgary, Heritage Medical Research Clinic, Trw Bldg 5 Floor, 3280 Hospital Dri. NW	Calgary	Alberta
Canada	University of Alberta, Glenrose Rehab Hosp, Movement Disorder Clinic , Rm 0601 Gleneast 10230 - 111 Avenue	Edmonton	Alberta
Canada	London Health Sciences Centre, University Hospital, 339 Windermere Road	London	Ontario
Canada	Centre For Movement Disorders, 2780 Bur Oak Avenue	Markham	Ontario
Canada	NORTH YORK GENERAL HOSPITAL (2), 4001 Leslie Street	Toronto	Ontario
Canada	North York General Hospital, 4001 Leslie Street	Toronto	Ontario
Canada	Department of Medical Genetics, Ubc Hospital, Room S179-2211 Westbrook Mall	Vancouver	British Columbia
United States	Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr	Albany	New York
United States	ST. LUKE'S HOSPITAL, 240 Centronia Road	Allentown	Pennsylvania
United States	University of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine	Ann Arbor	Michigan
United States	Emory University, Wesley Woods Center, 1841 Clifton Road NE Room 314	Atlanta	Georgia
United States	Johns Hopkins University, 600 North Wolfe Street, Meyer 2-181	Baltimore	Maryland
United States	University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B	Baltimore	Maryland
United States	University of Alabama At Birmingham, Pediatric Neurology Childrens, Harbor Bldg Suite 314, 1600 7Th Avenue South	Birmingham	Alabama
United States	Idaho Elks Rehabilitation Hospital, 600 North Robbins Road	Boise	Idaho
United States	Boston University School of Medicine, Department of Neurology, 715 Albany Street C329	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	Massachusetts General Hospital, 149 13Th Street Suite 2241	Charlestown	Massachusetts
United States	Rush University Medical Center, Department of Neurological Sciences, 1725 West Harrison Suite 755	Chicago	Illinois
United States	University of Cincinnati/Cincinnati Children'S Hospital, 222 Piedmont Avenue, Suite 3200	Cincinnati	Ohio
United States	OHIO STATE UNIVERSITY , 2006 Kenny Road	Columbus	Ohio
United States	UN oF TEXAS SOUTHWESTERN MED CENTER DALLAS, 5323 HARRY HINES BOULEVARD H1.108	Dallas	Texas
United States	Duke University, 932 Morreene Road #213	Durham	North Carolina
United States	Nj Neuroscience Institute, Jfk Medical Center, 65 James Street	Edison	New Jersey
United States	WASHINGTON REGIONAL MEDICAL CENTER, 3215 N. North Hills Blvd	Fayetteville	Arkansas
United States	University of Florida Center for Movement Disorders and Neurorestoration, 3450 Hull Road, 4th Floor	Gainesville	Florida
United States	Struthers Parkinson'S Center, 6701 Country Club Drive	Golden Valley	Minnesota
United States	Baylor College of Medicine, 6550 Fannin Suite 1801	Houston	Texas
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 California Irvine, Department of Neurology, 100 Irvine Hall	Irvine	California
United States	University of Kansas Medical Center, Department of Neurology, 3599 Rainbow Blvd Mail Stop 2012	Kansas City	Kansas
United States	University of Las Vegas School of Medicine, 1707 W. Charleston Blvd, Suite 220	Las Vegas	Nevada
United States	Colorado Neurological Institute, Movement Disorders Center, 701 East Hampden Avenue Suite 510	Littleton	Colorado
United States	North Shore-Lij Health System, 350 Community Drive Room 110, Research Institute	Manhasset	New York
United States	The University of Tennesee Health Science Cen, 855 Monroe Avenue, Department of Neurology, Room 415 Link Bldg	Memphis	Tennessee
United States	UNIVERSITY OF MIAMI, 1150 NW 14th STREET, #401	Miami	Florida
United States	Columbia University, Sergievsky Center P&S Box 16, 630 West 168Th Street	New York	New York
United States	University of Pennsylvania, Pennsylvania Hospital Department of Neurology , 330 South 9Th Street	Philadelphia	Pennsylvania
United States	University of Pittsburgh Kaufmann Medical Building, 3471 Fifth Avunue, Suite 811	Pittsburgh	Pennsylvania
United States	BUTLER HOSPTIAL MOVEMENT DISORDER PROGRAM, 345 Blackstone Boulevard	Providence	Rhode Island
United States	University of Rochester, Department of Neurology, 919 Westfall Road Building C Suite 220	Rochester	New York
United States	University of California Davis, Medical Center Dept of Neurology, Acc Building Suite 3700, 4860 Y Street	Sacramento	California
United States	Mayo Clinic Arizona, 13400 East Shea Boulevard, Csu-Cp21B	Scottsdale	Arizona
United States	Washington University School of Medicine, Box 8111, 660 South Euclid	St Louis	Missouri
United States	University of South Florida, College of Medicine Dept of Neurology, 12901 Bruce B Downs Blvd Mdc-55	Tampa	Florida
United States	Hereditary Neurological Disease Centre (Hndc),3223 N. Webb, Suite 4	Wichita	Kansas
United States	Wake Forest University, Baptist Med Center, Department of Neurology, Medical Center Boulevard	Winston Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Neurological Disorders and Stroke (NINDS), University of Rochester

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

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* Note: There are 73 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total functional capacity		over 5 years	No
Secondary	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		duration of the trial	Yes