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TerminatedNCT006088812CAREUpdated Mar 30, 2016Results posted

Coenzyme Q10 in Huntington's Disease (HD)

A Phase 3 interventional study of coenzyme Q10 and placebo in Huntington's Disease, sponsored by Massachusetts General Hospital. Terminated at 49 sites in 3 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2016-03-30.

Sponsored by Massachusetts General Hospital · Phase 3, Interventional, and Treatment

Why this study was terminated
Futility analysis failed to showed likelihoo of benefit of CoQ 2400 mg/day.
Phase
Phase 3
Study type
Interventional
Enrollment
609
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Huntington's Disease

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Keywords

  • Huntington's disease
  • Huntington disease
  • HD
  • coenzyme Q10
  • CoQ
03

In context

Huntington Disease

285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.

This study's enrollment of 609 is above the median of 40 across 203 interventional studies indexed under Huntington Disease.

Browse Huntington Disease studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
609 participants (actual)

Study arms

  • Active comparator
    A - coenzyme Q10 2400 mg/day

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

    Drug: coenzyme Q10

  • Placebo comparator
    B - Placebo

    Randomized to placebo

    Other: placebo

Interventions

  • Drugcoenzyme Q10

    4 - 300 mg CoQ chewable wafers taken orally twice a day

    Also known as: CoQ

  • Otherplacebo

    an inactive substance

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 5 years

Secondary outcomes

  1. 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).

    Time frame: Baseline and Month 60

  2. 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.

    Time frame: Baseline and Month 60

  3. 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.

    Time frame: Baseline and Month 60

  4. 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.

    Time frame: Baseline and Month 60

  5. 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.

    Time frame: Baseline and Month 60

  6. 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.

    Time frame: Baseline and Month 60

  7. 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.

    Time frame: Baseline and Month 60

  8. 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.

    Time frame: Baseline and Month 60

  9. 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.

    Time frame: Baseline and Month 60

  10. 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.

    Time frame: Baseline and Month 60

  11. 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 frame: Baseline and Month 60

  12. 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 frame: 5 years

  13. 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).

    Time frame: 5 years

  14. Number Completing Study at Assigned Dosage Level

    Time frame: 5 years

07

Results

Posted Mar 30, 2016
Limitations and caveats
An interim analysis for futility revealed a conditional power of \< 5% for the primary analysis, and the trial was halted in July, 2014. Only data collected prior to this time were included in the final analyses.

Participant flow

Participant flow — Overall Study
MilestoneA - Coenzyme Q10 2400 mg/DayB - Placebo
Started303306
Completed224240
Not completed7966
Withdrew: Death2213
Withdrew: Adverse event53
Withdrew: Lost to follow-up2814
Withdrew: Withdrawal by subject1829
Withdrew: Physician decision55
Withdrew: Institutionalized12

Outcome measures

PrimaryJoint 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).

Time frame:
5 years
Reported as:
Mean · rank
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))
rankA - Coenzyme Q10 2400 mg/DayB - Placebo
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))303.3 ± 173.1306.7 ± 179.0
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Π hat: 0.494 · 95% CI 0.454 to 0.534π hat is the estimate of the probability π that a randomly selected subject treated with CoQ has a better outcome than a randomly selected subject treated with placebo. Under the null hypothesis of no effect of CoQ, π = 0.50.
SecondaryChange 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).

Time frame:
Baseline and Month 60
Reported as:
Least squares mean · units on a scale
Change in Total Functional Capacity (TFC) Score From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Total Functional Capacity (TFC) Score From Baseline to Month 60-4.53 ± 0.25-4.76 ± 0.24
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): 0.23 · 95% CI -0.44 to 0.91
SecondaryChange 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.

Time frame:
Baseline and Month 60
Reported as:
Mean · units on a scale
Change in Functional Checklist Score From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Functional Checklist Score From Baseline to Month 60-7.93 ± 0.55-8.02 ± 0.54
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): 0.09 · 95% CI -1.40 to 1.58
SecondaryChange 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.

Time frame:
Baseline and Month 60
Reported as:
Mean · units on a scale
Change in Independence Scale Score From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Independence Scale Score From Baseline to Month 60-26.30 ± 1.92-24.86 ± 1.90
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): -1.44 · 95% CI -6.68 to 3.79
SecondaryChange 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.

Time frame:
Baseline and Month 60
Reported as:
Least squares mean · units on a scale
Change in Total Motor Score From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Total Motor Score From Baseline to Month 6018.06 ± 1.2219.18 ± 1.18
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): -1.12 · 95% CI -4.40 to 2.16
SecondaryChange 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.

Time frame:
Baseline and Month 60
Reported as:
Least squares mean · units on a scale
Change in Behavioral Frequency Score From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Behavioral Frequency Score From Baseline to Month 601.39 ± 0.551.43 ± 0.53
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): -0.04 · 95% CI -1.48 to 1.39
SecondaryChange 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.

Time frame:
Baseline and Month 60
Reported as:
Least squares mean · units on a scale
Change in Behavioral Frequency x Severity Score From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Behavioral Frequency x Severity Score From Baseline to Month 604.29 ± 1.525.06 ± 1.46
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): -0.77 · 95% CI -4.78 to 3.23
SecondaryChange 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.

Time frame:
Baseline and Month 60
Reported as:
Least squares mean · units on a scale
Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60-10.95 ± 0.66-11.36 ± 0.65
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): 0.41 · 95% CI -1.32 to 2.14
SecondaryChange 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.

Time frame:
Baseline and Month 60
Reported as:
Least squares mean · units on a scale
Change in Verbal Fluency Test From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Verbal Fluency Test From Baseline to Month 60-5.07 ± 0.79-4.47 ± 0.78
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): -0.60 · 95% CI -2.71 to 1.51
SecondaryChange 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.

Time frame:
Baseline and Month 60
Reported as:
Least squares mean · units on a scale
Change in Stroop Interference Test - Color Naming From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Stroop Interference Test - Color Naming From Baseline to Month 60-14.21 ± 1.00-14.51 ± 0.97
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (final values): 0.29 · 95% CI -2.28 to 2.87
SecondaryChange 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.

Time frame:
Baseline and Month 60
Reported as:
Least squares mean · units on a scale
Change in Stroop Interference Test - Word Reading From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Stroop Interference Test - Word Reading From Baseline to Month 60-15.25 ± 1.36-19.13 ± 1.32
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): 3.88 · 95% CI 0.31 to 7.44
SecondaryChange 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 frame:
Baseline and Month 60
Reported as:
Least squares mean · units on a scale
Change in Stroop Interference Test - Interference From Baseline to Month 60
units on a scaleA - Coenzyme Q10 2400 mg/DayB - Placebo
Change in Stroop Interference Test - Interference From Baseline to Month 60-7.57 ± 0.81-8.61 ± 0.79
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Mean difference (net): 1.04 · 95% CI -1.10 to 3.18
SecondaryTime 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 frame:
5 years
Reported as:
Median · days to event
Time to a Two-Point Decline in TFC Score or Death
days to eventA - Coenzyme Q10 2400 mg/DayB - Placebo
Time to a Two-Point Decline in TFC Score or Death553 (545 to 728)549 (395 to 726)
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Hazard ratio (hr): 0.99 · 95% CI 0.81 to 1.20
SecondaryTime 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).

Time frame:
5 years
Reported as:
Median · days to event
Time to a Three-Point Decline in TFC Score or Death
days to eventA - Coenzyme Q10 2400 mg/DayB - Placebo
Time to a Three-Point Decline in TFC Score or Death917 (760 to 1092)911 (737 to 1092)
Statistical analysis
  • A - Coenzyme Q10 2400 mg/Day vs B - Placebo · Hazard ratio (hr): 0.93 · 95% CI 0.75 to 1.15
SecondaryNumber Completing Study at Assigned Dosage Level
Time frame:
5 years
Reported as:
Number · participants completing study on drug
Number Completing Study at Assigned Dosage Level
participants completing study on drugA - Coenzyme Q10 2400 mg/DayB - Placebo
Number Completing Study at Assigned Dosage Level98108

Adverse events

Collected over 5 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
A - Coenzyme Q10 2400 mg/Day—76/303 (25.1%)276/303 (91.1%)
B - Placebo—83/306 (27.1%)280/306 (91.5%)
Most frequent serious events
Showing 10 of 129
Most frequent serious events
EventA - Coenzyme Q10 2400 mg/DayB - Placebo
SUICIDE ATTEMPTPsychiatric disorders10/3038/306
SUICIDAL IDEATIONPsychiatric disorders3/3037/306
DEPRESSIONPsychiatric disorders2/3036/306
PNEUMONIAInfections and infestations2/3035/306
FALLInjury, poisoning and procedural complications3/3035/306
SUBDURAL HAEMATOMAInjury, poisoning and procedural complications1/3035/306
COMPLETED SUICIDEPsychiatric disorders4/3031/306
SYNCOPENervous system disorders3/3032/306
MYOCARDIAL INFARCTIONCardiac disorders0/3033/306
HUNTINGTON'S DISEASECongenital, familial and genetic disorders2/3032/306
Most frequent other events
Showing 10 of 25
Most frequent other events
EventA - Coenzyme Q10 2400 mg/DayB - Placebo
FALLInjury, poisoning and procedural complications72/30384/306
DEPRESSIONPsychiatric disorders61/30366/306
INSOMNIAPsychiatric disorders35/30364/306
URINARY TRACT INFECTIONInfections and infestations33/30346/306
CHOREANervous system disorders37/30344/306
DIARRHOEAGastrointestinal disorders36/30343/306
ANXIETYPsychiatric disorders36/30342/306
IRRITABILITYPsychiatric disorders36/30338/306
NASOPHARYNGITISInfections and infestations27/30334/306
WEIGHT DECREASEDInvestigations25/30333/306

Baseline characteristics

Age, Continuous
Age, Continuous(years)A - Coenzyme Q10 2400 mg/DayB - PlaceboTotal
Mean50.5 ± 11.950.7 ± 11.650.6 ± 11.7
Sex: Female, Male
Sex: Female, Male(Participants)A - Coenzyme Q10 2400 mg/DayB - PlaceboTotal
Female149164313
Male154142296
08

Study locations

49 sites
  • University of Alabama At Birmingham, Pediatric Neurology Childrens, Harbor Bldg Suite 314, 1600 7Th Avenue South
    Birmingham, Alabama 35233-1711, United States
  • Mayo Clinic Arizona, 13400 East Shea Boulevard, Csu-Cp21B
    Scottsdale, Arizona 85259, United States
  • WASHINGTON REGIONAL MEDICAL CENTER, 3215 N. North Hills Blvd
    Fayetteville, Arkansas 72703, United States
  • University of California Irvine, Department of Neurology, 100 Irvine Hall
    Irvine, California 92697-4275, United States
  • University of California Davis, Medical Center Dept of Neurology, Acc Building Suite 3700, 4860 Y Street
    Sacramento, California 95817, United States
  • Colorado Neurological Institute, Movement Disorders Center, 701 East Hampden Avenue Suite 510
    Littleton, Colorado 80120, United States
  • University of Florida Center for Movement Disorders and Neurorestoration, 3450 Hull Road, 4th Floor
    Gainesville, Florida 32607, United States
  • UNIVERSITY OF MIAMI, 1150 NW 14th STREET, #401
    Miami, Florida 33136, United States
  • University of South Florida, College of Medicine Dept of Neurology, 12901 Bruce B Downs Blvd Mdc-55
    Tampa, Florida 33612, United States
  • Emory University, Wesley Woods Center, 1841 Clifton Road NE Room 314
    Atlanta, Georgia 30329, United States
  • Idaho Elks Rehabilitation Hospital, 600 North Robbins Road
    Boise, Idaho 83702, United States
  • Rush University Medical Center, Department of Neurological Sciences, 1725 West Harrison Suite 755
    Chicago, Illinois 60612, United States
  • Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
    Indianapolis, Indiana 46202, United States
  • University of Iowa Hospital and Clinics, 200 Hawkins Road, Room W263 General Hospital
    Iowa City, Iowa 52242-1000, United States
  • University of Kansas Medical Center, Department of Neurology, 3599 Rainbow Blvd Mail Stop 2012
    Kansas City, Kansas 66160-7314, United States
  • Hereditary Neurological Disease Centre (Hndc),3223 N. Webb, Suite 4
    Wichita, Kansas 67226, United States
  • University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B
    Baltimore, Maryland 21201, United States
  • Johns Hopkins University, 600 North Wolfe Street, Meyer 2-181
    Baltimore, Maryland 21287, United States
  • Boston University School of Medicine, Department of Neurology, 715 Albany Street C329
    Boston, Massachusetts 02118, United States
  • Massachusetts General Hospital, 149 13Th Street Suite 2241
    Charlestown, Massachusetts 02129, United States
  • University of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine
    Ann Arbor, Michigan 48109-0028, United States
  • Struthers Parkinson'S Center, 6701 Country Club Drive
    Golden Valley, Minnesota 55427, United States
  • Washington University School of Medicine, Box 8111, 660 South Euclid
    St Louis, Missouri 63110, United States
  • University of Las Vegas School of Medicine, 1707 W. Charleston Blvd, Suite 220
    Las Vegas, Nevada 89102, United States
  • Cooper University Hospital
    Camden, New Jersey 08103, United States
  • Nj Neuroscience Institute, Jfk Medical Center, 65 James Street
    Edison, New Jersey 08818, United States
  • Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr
    Albany, New York 12208, United States
  • North Shore-Lij Health System, 350 Community Drive Room 110, Research Institute
    Manhasset, New York 11030, United States
  • Columbia University, Sergievsky Center P&S Box 16, 630 West 168Th Street
    New York, New York 10032, United States
  • University of Rochester, Department of Neurology, 919 Westfall Road Building C Suite 220
    Rochester, New York 14618, United States
  • Duke University, 932 Morreene Road #213
    Durham, North Carolina 27705, United States
  • Wake Forest University, Baptist Med Center, Department of Neurology, Medical Center Boulevard
    Winston Salem, North Carolina 27157, United States
  • University of Cincinnati/Cincinnati Children'S Hospital, 222 Piedmont Avenue, Suite 3200
    Cincinnati, Ohio 45219, United States
  • OHIO STATE UNIVERSITY , 2006 Kenny Road
    Columbus, Ohio 43212, United States
  • ST. LUKE'S HOSPITAL, 240 Centronia Road
    Allentown, Pennsylvania 18104, United States
  • University of Pennsylvania, Pennsylvania Hospital Department of Neurology , 330 South 9Th Street
    Philadelphia, Pennsylvania 19107, United States
  • University of Pittsburgh Kaufmann Medical Building, 3471 Fifth Avunue, Suite 811
    Pittsburgh, Pennsylvania 15213, United States
  • BUTLER HOSPTIAL MOVEMENT DISORDER PROGRAM, 345 Blackstone Boulevard
    Providence, Rhode Island 02906, United States
  • The University of Tennesee Health Science Cen, 855 Monroe Avenue, Department of Neurology, Room 415 Link Bldg
    Memphis, Tennessee 38163, United States
  • UN oF TEXAS SOUTHWESTERN MED CENTER DALLAS, 5323 HARRY HINES BOULEVARD H1.108
    Dallas, Texas 75390-9016, United States
  • Baylor College of Medicine, 6550 Fannin Suite 1801
    Houston, Texas 77030, United States
  • Westmead Hospital, Department of Neurology Level 1, Po Box 533
    Wentworthville, New South Wales 2145, Australia
  • University of Calgary, Heritage Medical Research Clinic, Trw Bldg 5 Floor, 3280 Hospital Dri. NW
    Calgary, Alberta T2N 4Z6, Canada
  • University of Alberta, Glenrose Rehab Hosp, Movement Disorder Clinic , Rm 0601 Gleneast 10230 - 111 Avenue
    Edmonton, Alberta T5G 0B7, Canada
  • Department of Medical Genetics, Ubc Hospital, Room S179-2211 Westbrook Mall
    Vancouver, British Columbia V6T 2B5, Canada
  • London Health Sciences Centre, University Hospital, 339 Windermere Road
    London, Ontario N6A 5A5, Canada
  • Centre For Movement Disorders, 2780 Bur Oak Avenue
    Markham, Ontario L4A 1G8, Canada
  • NORTH YORK GENERAL HOSPITAL (2), 4001 Leslie Street
    Toronto, Ontario M2K 1E1, Canada
  • North York General Hospital, 4001 Leslie Street
    Toronto, Ontario M2R 1N5, Canada
09

References and documents

Publications

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  • Gines S, Seong IS, Fossale E, Ivanova E, Trettel F, Gusella JF, Wheeler VC, Persichetti F, MacDonald ME. Specific progressive cAMP reduction implicates energy deficit in presymptomatic Huntington's disease knock-in mice. Hum Mol Genet. 2003 Mar 1;12(5):497-508. doi: 10.1093/hmg/ddg046. PubMed 12588797 ↗
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  • Ferrante RJ, Andreassen OA, Jenkins BG, Dedeoglu A, Kuemmerle S, Kubilus JK, Kaddurah-Daouk R, Hersch SM, Beal MF. Neuroprotective effects of creatine in a transgenic mouse model of Huntington's disease. J Neurosci. 2000 Jun 15;20(12):4389-97. doi: 10.1523/JNEUROSCI.20-12-04389.2000. PubMed 10844007 ↗
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  • McGarry A, Auinger P, Kieburtz KD, Bredlau AL, Hersch SM, Rosas HD. Suicidality Risk Factors Across the CARE-HD, 2CARE, and CREST-E Clinical Trials in Huntington Disease. Neurol Clin Pract. 2022 Apr;12(2):131-138. doi: 10.1212/CPJ.0000000000001161. PubMed 35747889 ↗
  • McGarry A, McDermott MP, Kieburtz K, Fung WLA, McCusker E, Peng J, de Blieck EA, Cudkowicz M; Huntington Study Group 2CARE Investigators and Coordinators. Risk factors for suicidality in Huntington disease: An analysis of the 2CARE clinical trial. Neurology. 2019 Apr 2;92(14):e1643-e1651. doi: 10.1212/WNL.0000000000007244. Epub 2019 Mar 8. PubMed 30850442 ↗
  • 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. PubMed 27913695 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00608881
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of Rochester
Responsible party
Merit E. Cudkowicz, MD (Julieanne Dorn Professor of Neurology, Massachusetts General Hospital) — Principal investigator
First posted
Feb 6, 2008
Start date
Mar 2008
Primary completion
Nov 2014
Completion
May 2015
Results posted
Mar 30, 2016
Last update
Mar 30, 2016

Study contacts

Merit Cudkowicz, MD MSc
principal investigator · Massachusetts General Hospital
Michael McDermott, PhD
principal investigator · University of Rochester, Biostatistics
Karl Kieburtz, MD MPH
principal investigator · Director, Clinical Trials Coordination Center, University of Rochester

Oversight

Data monitoring committee
Yes
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