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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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))
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Change in Total Functional Capacity (TFC) Score From Baseline to Month 60
Timepoint [1] 0 0
Baseline and Month 60
Secondary outcome [2] 0 0
Change in Functional Checklist Score From Baseline to Month 60
Timepoint [2] 0 0
Baseline and Month 60
Secondary outcome [3] 0 0
Change in Independence Scale Score From Baseline to Month 60
Timepoint [3] 0 0
Baseline and Month 60
Secondary outcome [4] 0 0
Change in Total Motor Score From Baseline to Month 60
Timepoint [4] 0 0
Baseline and Month 60
Secondary outcome [5] 0 0
Change in Behavioral Frequency Score From Baseline to Month 60
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
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
Timepoint [7] 0 0
Baseline and Month 60
Secondary outcome [8] 0 0
Change in Verbal Fluency Test From Baseline to Month 60
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
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
Timepoint [10] 0 0
Baseline and Month 60
Secondary outcome [11] 0 0
Change in Stroop Interference Test - Interference From Baseline to Month 60
Timepoint [11] 0 0
Baseline and Month 60
Secondary outcome [12] 0 0
Time to a Two-Point Decline in TFC Score or Death
Timepoint [12] 0 0
5 years
Secondary outcome [13] 0 0
Time to a Three-Point Decline in TFC Score or Death
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
609
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Merit Cudkowicz, MD MSc
Address 0 0
Massachusetts General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00608881