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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00608881




Registration number
NCT00608881
Ethics application status
Date submitted
4/02/2008
Date registered
6/02/2008
Date last updated
30/03/2016

Titles & IDs
Public title
Coenzyme Q10 in Huntington's Disease (HD)
Scientific title
Coenzyme Q10 in Huntington's Disease (HD)
Secondary ID [1] 0 0
5U01NS052592
Secondary ID [2] 0 0
2CARE 01.00
Universal Trial Number (UTN)
Trial acronym
2CARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - coenzyme Q10
Other interventions - placebo

Active Comparator: A - coenzyme Q10 2400 mg/day - Randomized to active treatment (coenzyme Q10 2400 mg/day)

Placebo Comparator: B - Placebo - Randomized to placebo


Treatment: Drugs: coenzyme Q10
4 - 300 mg CoQ chewable wafers taken orally twice a day

Other interventions: placebo
an inactive substance

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
Baseline and Month 60
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline and Month 60
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline and Month 60
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline and Month 60
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline and Month 60
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline and Month 60
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline and Month 60
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline and Month 60
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline and Month 60
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline and Month 60
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Baseline and Month 60
Secondary outcome [12] 0 0
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).
Timepoint [12] 0 0
5 years
Secondary outcome [13] 0 0
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).
Timepoint [13] 0 0
5 years
Secondary outcome [14] 0 0
Number Completing Study at Assigned Dosage Level
Timepoint [14] 0 0
5 years

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital, Department of Neurology Level 1, Po Box 533 - Wentworthville
Recruitment postcode(s) [1] 0 0
2145 - Wentworthville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
Rhode Island
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
Massachusetts General Hospital
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Rochester
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00608881
Trial related presentations / publications
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Public notes

Contacts
Principal investigator
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Merit Cudkowicz, MD MSc
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Massachusetts General Hospital
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Contact person for public queries
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Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00608881