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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00608881
Date of registration: 04/02/2008
Prospective Registration: Yes
Primary sponsor: Massachusetts General Hospital
Public title: Coenzyme Q10 in Huntington's Disease (HD) 2CARE
Scientific title: Coenzyme Q10 in Huntington's Disease (HD)
Date of first enrolment: March 2008
Target sample size: 609
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00608881
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Australia Canada United States
Contacts
Name:     Karl Kieburtz, MD MPH
Address: 
Telephone:
Email:
Affiliation:  Director, Clinical Trials Coordination Center, University of Rochester
Name:     Merit Cudkowicz, MD MSc
Address: 
Telephone:
Email:
Affiliation:  Massachusetts General Hospital
Name:     Michael McDermott, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Rochester, Biostatistics
Key inclusion & exclusion 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)



Age minimum: 16 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Huntington's Disease
Intervention(s)
Drug: coenzyme Q10
Other: placebo
Primary Outcome(s)
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)) [Time Frame: 5 years]
Secondary Outcome(s)
Change in Behavioral Frequency Score From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Behavioral Frequency x Severity Score From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Functional Checklist Score From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Independence Scale Score From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Stroop Interference Test - Color Naming From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Stroop Interference Test - Interference From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Stroop Interference Test - Word Reading From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Total Functional Capacity (TFC) Score From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Total Motor Score From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Change in Verbal Fluency Test From Baseline to Month 60 [Time Frame: Baseline and Month 60]
Number Completing Study at Assigned Dosage Level [Time Frame: 5 years]
Time to a Three-Point Decline in TFC Score or Death [Time Frame: 5 years]
Time to a Two-Point Decline in TFC Score or Death [Time Frame: 5 years]
Secondary ID(s)
2CARE 01.00
5R01NS052619
5U01NS052592
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Ethics review
Results
Results available: Yes
Date Posted: 30/03/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00608881
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