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Coenzyme Q10 in Huntington's Disease (HD) (2CARE)

Primary Purpose

Huntington's Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
coenzyme Q10
placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington's Disease focused on measuring Huntington's disease, Huntington disease, HD, coenzyme Q10, CoQ

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama At Birmingham, Pediatric Neurology Childrens, Harbor Bldg Suite 314, 1600 7Th Avenue South
  • Mayo Clinic Arizona, 13400 East Shea Boulevard, Csu-Cp21B
  • WASHINGTON REGIONAL MEDICAL CENTER, 3215 N. North Hills Blvd
  • University of California Irvine, Department of Neurology, 100 Irvine Hall
  • University of California Davis, Medical Center Dept of Neurology, Acc Building Suite 3700, 4860 Y Street
  • Colorado Neurological Institute, Movement Disorders Center, 701 East Hampden Avenue Suite 510
  • University of Florida Center for Movement Disorders and Neurorestoration, 3450 Hull Road, 4th Floor
  • UNIVERSITY OF MIAMI, 1150 NW 14th STREET, #401
  • University of South Florida, College of Medicine Dept of Neurology, 12901 Bruce B Downs Blvd Mdc-55
  • Emory University, Wesley Woods Center, 1841 Clifton Road NE Room 314
  • Idaho Elks Rehabilitation Hospital, 600 North Robbins Road
  • Rush University Medical Center, Department of Neurological Sciences, 1725 West Harrison Suite 755
  • Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
  • University of Iowa Hospital and Clinics, 200 Hawkins Road, Room W263 General Hospital
  • University of Kansas Medical Center, Department of Neurology, 3599 Rainbow Blvd Mail Stop 2012
  • Hereditary Neurological Disease Centre (Hndc),3223 N. Webb, Suite 4
  • University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B
  • Johns Hopkins University, 600 North Wolfe Street, Meyer 2-181
  • Boston University School of Medicine, Department of Neurology, 715 Albany Street C329
  • Massachusetts General Hospital, 149 13Th Street Suite 2241
  • University of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine
  • Struthers Parkinson'S Center, 6701 Country Club Drive
  • Washington University School of Medicine, Box 8111, 660 South Euclid
  • University of Las Vegas School of Medicine, 1707 W. Charleston Blvd, Suite 220
  • Cooper University Hospital
  • Nj Neuroscience Institute, Jfk Medical Center, 65 James Street
  • Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr
  • North Shore-Lij Health System, 350 Community Drive Room 110, Research Institute
  • Columbia University, Sergievsky Center P&S Box 16, 630 West 168Th Street
  • University of Rochester, Department of Neurology, 919 Westfall Road Building C Suite 220
  • Duke University, 932 Morreene Road #213
  • Wake Forest University, Baptist Med Center, Department of Neurology, Medical Center Boulevard
  • University of Cincinnati/Cincinnati Children'S Hospital, 222 Piedmont Avenue, Suite 3200
  • OHIO STATE UNIVERSITY , 2006 Kenny Road
  • ST. LUKE'S HOSPITAL, 240 Centronia Road
  • University of Pennsylvania, Pennsylvania Hospital Department of Neurology , 330 South 9Th Street
  • University of Pittsburgh Kaufmann Medical Building, 3471 Fifth Avunue, Suite 811
  • BUTLER HOSPTIAL MOVEMENT DISORDER PROGRAM, 345 Blackstone Boulevard
  • The University of Tennesee Health Science Cen, 855 Monroe Avenue, Department of Neurology, Room 415 Link Bldg
  • UN oF TEXAS SOUTHWESTERN MED CENTER DALLAS, 5323 HARRY HINES BOULEVARD H1.108
  • Baylor College of Medicine, 6550 Fannin Suite 1801
  • Westmead Hospital, Department of Neurology Level 1, Po Box 533
  • University of Calgary, Heritage Medical Research Clinic, Trw Bldg 5 Floor, 3280 Hospital Dri. NW
  • University of Alberta, Glenrose Rehab Hosp, Movement Disorder Clinic , Rm 0601 Gleneast 10230 - 111 Avenue
  • Department of Medical Genetics, Ubc Hospital, Room S179-2211 Westbrook Mall
  • London Health Sciences Centre, University Hospital, 339 Windermere Road
  • Centre For Movement Disorders, 2780 Bur Oak Avenue
  • NORTH YORK GENERAL HOSPITAL (2), 4001 Leslie Street
  • North York General Hospital, 4001 Leslie Street

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A - coenzyme Q10 2400 mg/day

B - Placebo

Arm Description

Randomized to active treatment (coenzyme Q10 2400 mg/day)

Randomized to placebo

Outcomes

Primary Outcome Measures

Joint Rank (Combination of Time to Death (for Subjects Who Died) and Change in Total Functional Capacity Score (TFC) From Baseline to Month 60 (for Subjects Who Survived))
The primary outcome variable at the start of the trial was the change in TFC score from baseline to Month 60. The Data and Safety Monitoring Board recommended to the trial leadership that they reconsider how they accommodate missing data from subjects who die in their primary analysis of the change in TFC score. Based on these recommendations, the trial leadership changed the primary analysis to that of a joint rank approach. TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).

Secondary Outcome Measures

Change in Total Functional Capacity (TFC) Score From Baseline to Month 60
TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).
Change in Functional Checklist Score From Baseline to Month 60
The functional assessment checklist includes 25 questions about common daily tasks. A score of 1 is given for each "yes" reply and a score of 0 is given for each "no" reply (scale range is 0-25). Higher scores indicate better functioning.
Change in Independence Scale Score From Baseline to Month 60
The independence scale assesses independence on a 0 to 100 scale with higher scores indicating better functioning.
Change in Total Motor Score From Baseline to Month 60
The motor section of the Unified Huntington's Disease Rating Scale (UHDRS) assesses motor features of Huntington disease with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor score is the sum of all the individual motor ratings, with higher scores (124) indicating more severe motor impairment than lower scores. The score ranges from 0 to 124.
Change in Behavioral Frequency Score From Baseline to Month 60
The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. A total score was calculated by summing up all the individual behavioral frequency items (range 0-56) with higher scores representing more severe behavioral impairment.
Change in Behavioral Frequency x Severity Score From Baseline to Month 60
The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. The total score is the sum of the product of the individual behavioral frequency and severity items (range 0-176) with higher scores representing more severe behavioral impairment.
Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60
The SDMT assesses attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The score is the number of correctly paired abstract symbols and specific numbers in 90 seconds with higher scores indicating better cognitive functioning.
Change in Verbal Fluency Test From Baseline to Month 60
The verbal fluency test is typically considered a measure of executive function. The score is the number of correct words produced across three 1-minute trials.
Change in Stroop Interference Test - Color Naming From Baseline to Month 60
Stroop Interference Test - color naming score is the total number of correct colors identified in 45 seconds and reflects processing speed.
Change in Stroop Interference Test - Word Reading From Baseline to Month 60
Stroop Interference Test - word reading score is the total number of correct words read in 45 seconds and reflects processing speed.
Change in Stroop Interference Test - Interference From Baseline to Month 60
Stroop Interference Test - interference score is the total number of correct items identified in 45 seconds and reflects an executive measure of inhibitory ability.
Time to a Two-Point Decline in TFC Score or Death
TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).
Time to a Three-Point Decline in TFC Score or Death
TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).
Number Completing Study at Assigned Dosage Level

Full Information

First Posted
February 4, 2008
Last Updated
February 29, 2016
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT00608881
Brief Title
Coenzyme Q10 in Huntington's Disease (HD)
Acronym
2CARE
Official Title
Coenzyme Q10 in Huntington's Disease (HD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Futility analysis failed to showed likelihoo of benefit of CoQ 2400 mg/day.
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease
Keywords
Huntington's disease, Huntington disease, HD, coenzyme Q10, CoQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - coenzyme Q10 2400 mg/day
Arm Type
Active Comparator
Arm Description
Randomized to active treatment (coenzyme Q10 2400 mg/day)
Arm Title
B - Placebo
Arm Type
Placebo Comparator
Arm Description
Randomized to placebo
Intervention Type
Drug
Intervention Name(s)
coenzyme Q10
Other Intervention Name(s)
CoQ
Intervention Description
4 - 300 mg CoQ chewable wafers taken orally twice a day
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
an inactive substance
Primary Outcome Measure Information:
Title
Joint Rank (Combination of Time to Death (for Subjects Who Died) and Change in Total Functional Capacity Score (TFC) From Baseline to Month 60 (for Subjects Who Survived))
Description
The primary outcome variable at the start of the trial was the change in TFC score from baseline to Month 60. The Data and Safety Monitoring Board recommended to the trial leadership that they reconsider how they accommodate missing data from subjects who die in their primary analysis of the change in TFC score. Based on these recommendations, the trial leadership changed the primary analysis to that of a joint rank approach. TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Change in Total Functional Capacity (TFC) Score From Baseline to Month 60
Description
TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).
Time Frame
Baseline and Month 60
Title
Change in Functional Checklist Score From Baseline to Month 60
Description
The functional assessment checklist includes 25 questions about common daily tasks. A score of 1 is given for each "yes" reply and a score of 0 is given for each "no" reply (scale range is 0-25). Higher scores indicate better functioning.
Time Frame
Baseline and Month 60
Title
Change in Independence Scale Score From Baseline to Month 60
Description
The independence scale assesses independence on a 0 to 100 scale with higher scores indicating better functioning.
Time Frame
Baseline and Month 60
Title
Change in Total Motor Score From Baseline to Month 60
Description
The motor section of the Unified Huntington's Disease Rating Scale (UHDRS) assesses motor features of Huntington disease with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor score is the sum of all the individual motor ratings, with higher scores (124) indicating more severe motor impairment than lower scores. The score ranges from 0 to 124.
Time Frame
Baseline and Month 60
Title
Change in Behavioral Frequency Score From Baseline to Month 60
Description
The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. A total score was calculated by summing up all the individual behavioral frequency items (range 0-56) with higher scores representing more severe behavioral impairment.
Time Frame
Baseline and Month 60
Title
Change in Behavioral Frequency x Severity Score From Baseline to Month 60
Description
The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. The total score is the sum of the product of the individual behavioral frequency and severity items (range 0-176) with higher scores representing more severe behavioral impairment.
Time Frame
Baseline and Month 60
Title
Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60
Description
The SDMT assesses attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The score is the number of correctly paired abstract symbols and specific numbers in 90 seconds with higher scores indicating better cognitive functioning.
Time Frame
Baseline and Month 60
Title
Change in Verbal Fluency Test From Baseline to Month 60
Description
The verbal fluency test is typically considered a measure of executive function. The score is the number of correct words produced across three 1-minute trials.
Time Frame
Baseline and Month 60
Title
Change in Stroop Interference Test - Color Naming From Baseline to Month 60
Description
Stroop Interference Test - color naming score is the total number of correct colors identified in 45 seconds and reflects processing speed.
Time Frame
Baseline and Month 60
Title
Change in Stroop Interference Test - Word Reading From Baseline to Month 60
Description
Stroop Interference Test - word reading score is the total number of correct words read in 45 seconds and reflects processing speed.
Time Frame
Baseline and Month 60
Title
Change in Stroop Interference Test - Interference From Baseline to Month 60
Description
Stroop Interference Test - interference score is the total number of correct items identified in 45 seconds and reflects an executive measure of inhibitory ability.
Time Frame
Baseline and Month 60
Title
Time to a Two-Point Decline in TFC Score or Death
Description
TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).
Time Frame
5 years
Title
Time to a Three-Point Decline in TFC Score or Death
Description
TFC consists of five ordinally scaled items assessing a person's capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).
Time Frame
5 years
Title
Number Completing Study at Assigned Dosage Level
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merit Cudkowicz, MD MSc
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael McDermott, PhD
Organizational Affiliation
University of Rochester, Biostatistics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl Kieburtz, MD MPH
Organizational Affiliation
Director, Clinical Trials Coordination Center, University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama At Birmingham, Pediatric Neurology Childrens, Harbor Bldg Suite 314, 1600 7Th Avenue South
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1711
Country
United States
Facility Name
Mayo Clinic Arizona, 13400 East Shea Boulevard, Csu-Cp21B
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
WASHINGTON REGIONAL MEDICAL CENTER, 3215 N. North Hills Blvd
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
University of California Irvine, Department of Neurology, 100 Irvine Hall
City
Irvine
State/Province
California
ZIP/Postal Code
92697-4275
Country
United States
Facility Name
University of California Davis, Medical Center Dept of Neurology, Acc Building Suite 3700, 4860 Y Street
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Colorado Neurological Institute, Movement Disorders Center, 701 East Hampden Avenue Suite 510
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
University of Florida Center for Movement Disorders and Neurorestoration, 3450 Hull Road, 4th Floor
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
UNIVERSITY OF MIAMI, 1150 NW 14th STREET, #401
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida, College of Medicine Dept of Neurology, 12901 Bruce B Downs Blvd Mdc-55
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University, Wesley Woods Center, 1841 Clifton Road NE Room 314
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Idaho Elks Rehabilitation Hospital, 600 North Robbins Road
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Rush University Medical Center, Department of Neurological Sciences, 1725 West Harrison Suite 755
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospital and Clinics, 200 Hawkins Road, Room W263 General Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1000
Country
United States
Facility Name
University of Kansas Medical Center, Department of Neurology, 3599 Rainbow Blvd Mail Stop 2012
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7314
Country
United States
Facility Name
Hereditary Neurological Disease Centre (Hndc),3223 N. Webb, Suite 4
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University, 600 North Wolfe Street, Meyer 2-181
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston University School of Medicine, Department of Neurology, 715 Albany Street C329
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Massachusetts General Hospital, 149 13Th Street Suite 2241
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
University of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0028
Country
United States
Facility Name
Struthers Parkinson'S Center, 6701 Country Club Drive
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
Washington University School of Medicine, Box 8111, 660 South Euclid
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Las Vegas School of Medicine, 1707 W. Charleston Blvd, Suite 220
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Nj Neuroscience Institute, Jfk Medical Center, 65 James Street
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Facility Name
Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
North Shore-Lij Health System, 350 Community Drive Room 110, Research Institute
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Columbia University, Sergievsky Center P&S Box 16, 630 West 168Th Street
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester, Department of Neurology, 919 Westfall Road Building C Suite 220
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Duke University, 932 Morreene Road #213
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Wake Forest University, Baptist Med Center, Department of Neurology, Medical Center Boulevard
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati/Cincinnati Children'S Hospital, 222 Piedmont Avenue, Suite 3200
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
OHIO STATE UNIVERSITY , 2006 Kenny Road
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
ST. LUKE'S HOSPITAL, 240 Centronia Road
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
University of Pennsylvania, Pennsylvania Hospital Department of Neurology , 330 South 9Th Street
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Kaufmann Medical Building, 3471 Fifth Avunue, Suite 811
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
BUTLER HOSPTIAL MOVEMENT DISORDER PROGRAM, 345 Blackstone Boulevard
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
The University of Tennesee Health Science Cen, 855 Monroe Avenue, Department of Neurology, Room 415 Link Bldg
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
UN oF TEXAS SOUTHWESTERN MED CENTER DALLAS, 5323 HARRY HINES BOULEVARD H1.108
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9016
Country
United States
Facility Name
Baylor College of Medicine, 6550 Fannin Suite 1801
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Westmead Hospital, Department of Neurology Level 1, Po Box 533
City
Wentworthville
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
University of Calgary, Heritage Medical Research Clinic, Trw Bldg 5 Floor, 3280 Hospital Dri. NW
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta, Glenrose Rehab Hosp, Movement Disorder Clinic , Rm 0601 Gleneast 10230 - 111 Avenue
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Facility Name
Department of Medical Genetics, Ubc Hospital, Room S179-2211 Westbrook Mall
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
London Health Sciences Centre, University Hospital, 339 Windermere Road
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Centre For Movement Disorders, 2780 Bur Oak Avenue
City
Markham
State/Province
Ontario
ZIP/Postal Code
L4A 1G8
Country
Canada
Facility Name
NORTH YORK GENERAL HOSPITAL (2), 4001 Leslie Street
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Facility Name
North York General Hospital, 4001 Leslie Street
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2R 1N5
Country
Canada

12. IPD Sharing Statement

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27913695
Citation
McGarry A, McDermott M, Kieburtz K, de Blieck EA, Beal F, Marder K, Ross C, Shoulson I, Gilbert P, Mallonee WM, Guttman M, Wojcieszek J, Kumar R, LeDoux MS, Jenkins M, Rosas HD, Nance M, Biglan K, Como P, Dubinsky RM, Shannon KM, O'Suilleabhain P, Chou K, Walker F, Martin W, Wheelock VL, McCusker E, Jankovic J, Singer C, Sanchez-Ramos J, Scott B, Suchowersky O, Factor SA, Higgins DS Jr, Molho E, Revilla F, Caviness JN, Friedman JH, Perlmutter JS, Feigin A, Anderson K, Rodriguez R, McFarland NR, Margolis RL, Farbman ES, Raymond LA, Suski V, Kostyk S, Colcher A, Seeberger L, Epping E, Esmail S, Diaz N, Fung WL, Diamond A, Frank S, Hanna P, Hermanowicz N, Dure LS, Cudkowicz M; Huntington Study Group 2CARE Investigators and Coordinators. A randomized, double-blind, placebo-controlled trial of coenzyme Q10 in Huntington disease. Neurology. 2017 Jan 10;88(2):152-159. doi: 10.1212/WNL.0000000000003478. Epub 2016 Dec 2.
Results Reference
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Coenzyme Q10 in Huntington's Disease (HD)

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