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Trial record 63 of 192 for:    "huntington disease"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00608881
Recruitment Status : Terminated (Futility analysis failed to showed likelihoo of benefit of CoQ 2400 mg/day.)
First Posted : February 6, 2008
Results First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Information provided by (Responsible Party):
Merit E. Cudkowicz, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Huntington's Disease
Interventions Drug: coenzyme Q10
Other: placebo
Enrollment 609
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description

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

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

Randomized to placebo

placebo: an inactive substance

Period Title: Overall Study
Started 303 306
Completed 224 240
Not Completed 79 66
Reason Not Completed
Death             22             13
Adverse Event             5             3
Lost to Follow-up             28             14
Withdrawal by Subject             18             29
Physician Decision             5             5
Institutionalized             1             2
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo Total
Hide Arm/Group Description

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

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

Randomized to placebo

placebo: an inactive substance

Total of all reporting groups
Overall Number of Baseline Participants 303 306 609
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 303 participants 306 participants 609 participants
50.5  (11.9) 50.7  (11.6) 50.6  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 303 participants 306 participants 609 participants
Female
149
  49.2%
164
  53.6%
313
  51.4%
Male
154
  50.8%
142
  46.4%
296
  48.6%
1.Primary Outcome
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))
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Mean (Standard Deviation)
Unit of Measure: rank
303.3  (173.1) 306.7  (179.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments In this joint rank analysis, subjects are ranked from worst to best outcome with subjects who die being assigned the worst ranks (and ranked according to the time of death) and subjects who survive being ranked more favorably in the order of the change from baseline to Month 60 in TFC score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter π hat
Estimated Value 0.494
Confidence Interval (2-Sided) 95%
0.454 to 0.534
Estimation Comments π 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.
2.Secondary Outcome
Title Change in Total Functional Capacity (TFC) Score From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.53  (0.25) -4.76  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-0.44 to 0.91
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Functional Checklist Score From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Mean (Standard Error)
Unit of Measure: units on a scale
-7.93  (0.55) -8.02  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-1.40 to 1.58
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Independence Scale Score From Baseline to Month 60
Hide Description The independence scale assesses independence on a 0 to 100 scale with higher scores indicating better functioning.
Time Frame Baseline and Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Mean (Standard Error)
Unit of Measure: units on a scale
-26.30  (1.92) -24.86  (1.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.44
Confidence Interval (2-Sided) 95%
-6.68 to 3.79
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Total Motor Score From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
18.06  (1.22) 19.18  (1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.12
Confidence Interval (2-Sided) 95%
-4.40 to 2.16
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Behavioral Frequency Score From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.39  (0.55) 1.43  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-1.48 to 1.39
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Behavioral Frequency x Severity Score From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.29  (1.52) 5.06  (1.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-4.78 to 3.23
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-10.95  (0.66) -11.36  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-1.32 to 2.14
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Verbal Fluency Test From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.07  (0.79) -4.47  (0.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-2.71 to 1.51
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Stroop Interference Test - Color Naming From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-14.21  (1.00) -14.51  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
-2.28 to 2.87
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Stroop Interference Test - Word Reading From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-15.25  (1.36) -19.13  (1.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.88
Confidence Interval (2-Sided) 95%
0.31 to 7.44
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Stroop Interference Test - Interference From Baseline to Month 60
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.57  (0.81) -8.61  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
-1.10 to 3.18
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Time to a Two-Point Decline in TFC Score or Death
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Median (95% Confidence Interval)
Unit of Measure: days to event
553
(545 to 728)
549
(395 to 726)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.81 to 1.20
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Time to a Three-Point Decline in TFC Score or Death
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Median (95% Confidence Interval)
Unit of Measure: days to event
917
(760 to 1092)
911
(737 to 1092)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A - Coenzyme Q10 2400 mg/Day, B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.75 to 1.15
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Number Completing Study at Assigned Dosage Level
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description:

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

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

Randomized to placebo

placebo: an inactive substance

Overall Number of Participants Analyzed 303 306
Measure Type: Number
Unit of Measure: participants completing study on drug
98 108
Time Frame 5 years
Adverse Event Reporting Description Adverse events were assessed at each visit by recording all voluntary complaints of the subject and by assessment of clinical features. Subjects were questioned regarding the occurrence of any adverse event since the last visit. All adverse events were recorded on an Adverse Event Log case report form.
 
Arm/Group Title A - Coenzyme Q10 2400 mg/Day B - Placebo
Hide Arm/Group Description

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

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

Randomized to placebo

placebo: an inactive substance

All-Cause Mortality
A - Coenzyme Q10 2400 mg/Day B - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A - Coenzyme Q10 2400 mg/Day B - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   76/303 (25.08%)   83/306 (27.12%) 
Blood and lymphatic system disorders     
NEUTROPENIA  1  1/303 (0.33%)  0/306 (0.00%) 
Cardiac disorders     
ANGINA UNSTABLE  1  0/303 (0.00%)  1/306 (0.33%) 
ATRIAL FIBRILLATION  1  1/303 (0.33%)  0/306 (0.00%) 
CARDIAC ARREST  1  0/303 (0.00%)  1/306 (0.33%) 
CORONARY ARTERY DISEASE  1  0/303 (0.00%)  1/306 (0.33%) 
CORONARY ARTERY OCCLUSION  1  1/303 (0.33%)  0/306 (0.00%) 
MYOCARDIAL INFARCTION  1  0/303 (0.00%)  3/306 (0.98%) 
Congenital, familial and genetic disorders     
HUNTINGTON`S DISEASE  1  2/303 (0.66%)  2/306 (0.65%) 
Ear and labyrinth disorders     
VERTIGO  1  0/303 (0.00%)  1/306 (0.33%) 
Eye disorders     
RETINAL DETACHMENT  1  0/303 (0.00%)  1/306 (0.33%) 
Gastrointestinal disorders     
COLITIS  1  0/303 (0.00%)  1/306 (0.33%) 
CROHN`S DISEASE  1  0/303 (0.00%)  1/306 (0.33%) 
DIARRHOEA  1  1/303 (0.33%)  0/306 (0.00%) 
DYSPHAGIA  1  2/303 (0.66%)  2/306 (0.65%) 
HAEMORRHOIDS  1  1/303 (0.33%)  0/306 (0.00%) 
INTESTINAL OBSTRUCTION  1  1/303 (0.33%)  1/306 (0.33%) 
LARGE INTESTINAL OBSTRUCTION  1  1/303 (0.33%)  0/306 (0.00%) 
PEPTIC ULCER  1  1/303 (0.33%)  0/306 (0.00%) 
SMALL INTESTINAL OBSTRUCTION  1  1/303 (0.33%)  0/306 (0.00%) 
VOMITING  1  1/303 (0.33%)  0/306 (0.00%) 
General disorders     
CHEST PAIN  1  2/303 (0.66%)  0/306 (0.00%) 
DRUG WITHDRAWAL SYNDROME  1  0/303 (0.00%)  1/306 (0.33%) 
NON-CARDIAC CHEST PAIN  1  1/303 (0.33%)  0/306 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/303 (0.33%)  1/306 (0.33%) 
CHOLELITHIASIS  1  1/303 (0.33%)  0/306 (0.00%) 
Immune system disorders     
DRUG HYPERSENSITIVITY  1  0/303 (0.00%)  1/306 (0.33%) 
Infections and infestations     
ABSCESS  1  1/303 (0.33%)  0/306 (0.00%) 
ARTHRITIS INFECTIVE  1  0/303 (0.00%)  1/306 (0.33%) 
BACTERAEMIA  1  0/303 (0.00%)  1/306 (0.33%) 
CELLULITIS  1  0/303 (0.00%)  1/306 (0.33%) 
DIVERTICULITIS  1  0/303 (0.00%)  2/306 (0.65%) 
GASTROENTERITIS  1  0/303 (0.00%)  1/306 (0.33%) 
NECROTISING FASCIITIS  1  1/303 (0.33%)  0/306 (0.00%) 
PNEUMONIA  1  2/303 (0.66%)  5/306 (1.63%) 
SEPSIS  1  1/303 (0.33%)  0/306 (0.00%) 
SKIN GRAFT INFECTION  1  0/303 (0.00%)  1/306 (0.33%) 
STAPHYLOCOCCAL BACTERAEMIA  1  1/303 (0.33%)  0/306 (0.00%) 
STAPHYLOCOCCAL INFECTION  1  1/303 (0.33%)  0/306 (0.00%) 
URINARY TRACT INFECTION  1  0/303 (0.00%)  2/306 (0.65%) 
Injury, poisoning and procedural complications     
ACCIDENTAL OVERDOSE  1  1/303 (0.33%)  1/306 (0.33%) 
ANKLE FRACTURE  1  1/303 (0.33%)  1/306 (0.33%) 
COMMINUTED FRACTURE  1  1/303 (0.33%)  0/306 (0.00%) 
CONCUSSION  1  0/303 (0.00%)  1/306 (0.33%) 
FACIAL BONES FRACTURE  1  0/303 (0.00%)  1/306 (0.33%) 
FALL  1  3/303 (0.99%)  5/306 (1.63%) 
FEMUR FRACTURE  1  1/303 (0.33%)  0/306 (0.00%) 
FIBULA FRACTURE  1  1/303 (0.33%)  0/306 (0.00%) 
FRACTURE  1  2/303 (0.66%)  0/306 (0.00%) 
HIP FRACTURE  1  1/303 (0.33%)  2/306 (0.65%) 
INJURY  1  1/303 (0.33%)  0/306 (0.00%) 
INTENTIONAL OVERDOSE  1  1/303 (0.33%)  0/306 (0.00%) 
LIMB TRAUMATIC AMPUTATION  1  1/303 (0.33%)  0/306 (0.00%) 
ROAD TRAFFIC ACCIDENT  1  1/303 (0.33%)  1/306 (0.33%) 
SPINAL COMPRESSION FRACTURE  1  0/303 (0.00%)  1/306 (0.33%) 
SUBDURAL HAEMATOMA  1  1/303 (0.33%)  5/306 (1.63%) 
TIBIA FRACTURE  1  1/303 (0.33%)  0/306 (0.00%) 
TRAUMATIC FRACTURE  1  0/303 (0.00%)  1/306 (0.33%) 
UPPER LIMB FRACTURE  1  0/303 (0.00%)  1/306 (0.33%) 
WRIST FRACTURE  1  1/303 (0.33%)  0/306 (0.00%) 
Metabolism and nutrition disorders     
DEHYDRATION  1  1/303 (0.33%)  1/306 (0.33%) 
DIABETIC KETOACIDOSIS  1  1/303 (0.33%)  0/306 (0.00%) 
HYPERGLYCAEMIA  1  0/303 (0.00%)  1/306 (0.33%) 
HYPONATRAEMIA  1  1/303 (0.33%)  0/306 (0.00%) 
Musculoskeletal and connective tissue disorders     
NECK PAIN  1  0/303 (0.00%)  2/306 (0.65%) 
NOSE DEFORMITY  1  0/303 (0.00%)  1/306 (0.33%) 
OSTEOARTHRITIS  1  0/303 (0.00%)  1/306 (0.33%) 
OSTEOPOROSIS  1  1/303 (0.33%)  0/306 (0.00%) 
RHABDOMYOLYSIS  1  1/303 (0.33%)  0/306 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BASAL CELL CARCINOMA  1  0/303 (0.00%)  1/306 (0.33%) 
BRAIN NEOPLASM  1  1/303 (0.33%)  0/306 (0.00%) 
BREAST CANCER  1  1/303 (0.33%)  2/306 (0.65%) 
CARCINOID TUMOUR  1  1/303 (0.33%)  0/306 (0.00%) 
COLON CANCER METASTATIC  1  0/303 (0.00%)  1/306 (0.33%) 
GLIOMA  1  1/303 (0.33%)  0/306 (0.00%) 
INFLAMMATORY CARCINOMA OF THE BREAST  1  0/303 (0.00%)  1/306 (0.33%) 
LUNG NEOPLASM MALIGNANT  1  1/303 (0.33%)  1/306 (0.33%) 
MANTLE CELL LYMPHOMA  1  0/303 (0.00%)  1/306 (0.33%) 
PROSTATE CANCER  1  0/303 (0.00%)  1/306 (0.33%) 
UTERINE LEIOMYOMA  1  0/303 (0.00%)  1/306 (0.33%) 
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  1/303 (0.33%)  0/306 (0.00%) 
CHOREA  1  0/303 (0.00%)  1/306 (0.33%) 
CONVULSION  1  0/303 (0.00%)  2/306 (0.65%) 
HAEMORRHAGE INTRACRANIAL  1  0/303 (0.00%)  1/306 (0.33%) 
LOSS OF CONSCIOUSNESS  1  0/303 (0.00%)  2/306 (0.65%) 
PARKINSONISM  1  1/303 (0.33%)  0/306 (0.00%) 
SYNCOPE  1  3/303 (0.99%)  2/306 (0.65%) 
TOXIC ENCEPHALOPATHY  1  0/303 (0.00%)  1/306 (0.33%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/303 (0.00%)  1/306 (0.33%) 
Psychiatric disorders     
ABNORMAL BEHAVIOUR  1  1/303 (0.33%)  0/306 (0.00%) 
AGGRESSION  1  2/303 (0.66%)  2/306 (0.65%) 
AGITATION  1  1/303 (0.33%)  1/306 (0.33%) 
ANXIETY  1  1/303 (0.33%)  1/306 (0.33%) 
COMPLETED SUICIDE  1  4/303 (1.32%)  1/306 (0.33%) 
CONFUSIONAL STATE  1  0/303 (0.00%)  1/306 (0.33%) 
DELIRIUM  1  1/303 (0.33%)  0/306 (0.00%) 
DELUSION  1  1/303 (0.33%)  2/306 (0.65%) 
DEPRESSION  1  2/303 (0.66%)  6/306 (1.96%) 
HALLUCINATION, AUDITORY  1  1/303 (0.33%)  1/306 (0.33%) 
MAJOR DEPRESSION  1  2/303 (0.66%)  0/306 (0.00%) 
PANIC ATTACK  1  1/303 (0.33%)  0/306 (0.00%) 
PARANOIA  1  1/303 (0.33%)  0/306 (0.00%) 
PSYCHOTIC BEHAVIOUR  1  1/303 (0.33%)  0/306 (0.00%) 
PSYCHOTIC DISORDER  1  2/303 (0.66%)  1/306 (0.33%) 
SUICIDAL BEHAVIOUR  1  1/303 (0.33%)  1/306 (0.33%) 
SUICIDAL IDEATION  1  3/303 (0.99%)  7/306 (2.29%) 
SUICIDE ATTEMPT  1  10/303 (3.30%)  8/306 (2.61%) 
Renal and urinary disorders     
NEPHROLITHIASIS  1  0/303 (0.00%)  1/306 (0.33%) 
RENAL FAILURE  1  0/303 (0.00%)  2/306 (0.65%) 
Reproductive system and breast disorders     
UTERINE PROLAPSE  1  1/303 (0.33%)  0/306 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY FAILURE  1  1/303 (0.33%)  0/306 (0.00%) 
ASPIRATION  1  0/303 (0.00%)  1/306 (0.33%) 
ASTHMA  1  1/303 (0.33%)  1/306 (0.33%) 
BRONCHIECTASIS  1  0/303 (0.00%)  1/306 (0.33%) 
COUGH  1  1/303 (0.33%)  0/306 (0.00%) 
PNEUMONIA ASPIRATION  1  1/303 (0.33%)  0/306 (0.00%) 
UPPER AIRWAY OBSTRUCTION  1  0/303 (0.00%)  1/306 (0.33%) 
Surgical and medical procedures     
CORONARY ARTERY BYPASS  1  1/303 (0.33%)  0/306 (0.00%) 
DEEP BRAIN STIMULATION  1  0/303 (0.00%)  1/306 (0.33%) 
HAEMORRHOID OPERATION  1  1/303 (0.33%)  0/306 (0.00%) 
HERNIA REPAIR  1  0/303 (0.00%)  1/306 (0.33%) 
HIP ARTHROPLASTY  1  1/303 (0.33%)  0/306 (0.00%) 
HYSTERECTOMY  1  0/303 (0.00%)  1/306 (0.33%) 
KNEE ARTHROPLASTY  1  0/303 (0.00%)  1/306 (0.33%) 
SHOULDER ARTHROPLASTY  1  1/303 (0.33%)  0/306 (0.00%) 
SPINAL LAMINECTOMY  1  1/303 (0.33%)  0/306 (0.00%) 
SURGERY  1  1/303 (0.33%)  0/306 (0.00%) 
THYROIDECTOMY  1  0/303 (0.00%)  1/306 (0.33%) 
Vascular disorders     
HYPOTENSION  1  2/303 (0.66%)  0/306 (0.00%) 
ILIAC ARTERY OCCLUSION  1  1/303 (0.33%)  0/306 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A - Coenzyme Q10 2400 mg/Day B - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   276/303 (91.09%)   280/306 (91.50%) 
Gastrointestinal disorders     
CONSTIPATION  1  26/303 (8.58%)  22/306 (7.19%) 
DIARRHOEA  1  36/303 (11.88%)  43/306 (14.05%) 
DYSPHAGIA  1  25/303 (8.25%)  21/306 (6.86%) 
NAUSEA  1  31/303 (10.23%)  24/306 (7.84%) 
VOMITING  1  25/303 (8.25%)  23/306 (7.52%) 
General disorders     
FATIGUE  1  19/303 (6.27%)  16/306 (5.23%) 
Infections and infestations     
BRONCHITIS  1  16/303 (5.28%)  19/306 (6.21%) 
INFLUENZA  1  21/303 (6.93%)  17/306 (5.56%) 
NASOPHARYNGITIS  1  27/303 (8.91%)  34/306 (11.11%) 
SINUSITIS  1  14/303 (4.62%)  19/306 (6.21%) 
UPPER RESPIRATORY TRACT INFECTION  1  23/303 (7.59%)  27/306 (8.82%) 
URINARY TRACT INFECTION  1  33/303 (10.89%)  46/306 (15.03%) 
Injury, poisoning and procedural complications     
CONTUSION  1  10/303 (3.30%)  21/306 (6.86%) 
FALL  1  72/303 (23.76%)  84/306 (27.45%) 
LACERATION  1  14/303 (4.62%)  23/306 (7.52%) 
Investigations     
WEIGHT DECREASED  1  25/303 (8.25%)  33/306 (10.78%) 
Nervous system disorders     
BALANCE DISORDER  1  19/303 (6.27%)  21/306 (6.86%) 
CHOREA  1  37/303 (12.21%)  44/306 (14.38%) 
DIZZINESS  1  15/303 (4.95%)  16/306 (5.23%) 
HEADACHE  1  17/303 (5.61%)  14/306 (4.58%) 
Psychiatric disorders     
ANXIETY  1  36/303 (11.88%)  42/306 (13.73%) 
DEPRESSION  1  61/303 (20.13%)  66/306 (21.57%) 
INSOMNIA  1  35/303 (11.55%)  64/306 (20.92%) 
IRRITABILITY  1  36/303 (11.88%)  38/306 (12.42%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  13/303 (4.29%)  19/306 (6.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Merit Cudkowicz
Organization: Massachusetts General Hospital
Phone: 617-726-0813
EMail: mcudkowicz@partners.org
Publications:
Kowall N, Ferrante R, Martin J. Patterns of cell loss in Huntington's disease. Trends in Neurosciences 1987;10:24-29.
Riley D, Lang A. Movement Disorders. In: Bradley W, Daroff R, Fenichel G, eds. Neurology in Clinical Practice. The Neurological Disorders. Boston: Butterworth-Heinemann, 1991: 1563-1601.
Bruyn G. Huntington's chorea: Historical clinical and laboratory synopsis. In: Vinken P, Bruyn G, eds. Handbook of Clinical Neurology. Amsterdam, 1968: 298-378.
Greenamyre J, Shoulson I. Huntington's Disease. In: Calne D, ed. Neurodegenerative Diseases. Philadelphia: WB Saunders, 1994: 685-704.
Kido D, Shoulson I, Manzione J, Harnish P. Measurement of caudate nucleus and putamen atrophy in patients with Huntington's disease. Neuroradiology 1991;33:604-606.
Yamagami T, Okishio T, Toyama S, Kishi T. Correlation of serum coenzyme Q10 level and leukocute complex II activity in nformal and cardiovascular patients. In: Folkers K, Yamagami T, eds. Biomedical and clinical aspects of coenzyme Q: Elsevier Science Publishers, 1981: 79-89.
Dubois B, Brand M, Garcia de Yebenes J, et al. European-Huntington's-disease-Initiative (EHDI)-Trial: Objectives, design, and description of the study population at the end of inclusion. Mov Dis 2002;17:S319.
Bogentoft C, Edelund P, Olsson B, Widlund L, Westensen K. Biopharmaceutical aspects of intraveneous and oral administration of coenzyme Q10. In: Folkers K, Littarru G, Yamagami T, eds. Biomedical and clinical aspects of coenzyme Q.: Elsevier Science Publishers, 1991: 215-224.
Lucker P, Wetselsberg N, Hennings G, Rehn D. Pharmacokinetics of coenzyme ubidecarenone in healthy volunteers. In: Folkers K, Littarru G, Yamagami T, eds. Biomedical and clinical aspects of coenzyme Q: Elsevier Science Publishers, 1984: 143-151.
Micromedex. Ubidecarenone drug monograph. Engelwood 1995 May; Update 1998 Mar.
Weber C. Dietary intake and absorption of coenzyme Q. In: Kagan V, Quinn P, eds. Coenzyme Q: Molecular Mechanisms in Health and Disease. Boca Raton: CRC Press, 2001:209-215.
Saito Y, Kubo H, Bujo H, Yamamoto Y. The changes in plasma coenzyme Q10 level during the statin therapy for hypercholesterolemic patients. In: Second Conference of the International Coenzyme Q10 Association.; 2000, 2000: 59.
Layout table for additonal information
Responsible Party: Merit E. Cudkowicz, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00608881     History of Changes
Other Study ID Numbers: 2CARE 01.00
5U01NS052592 ( U.S. NIH Grant/Contract )
5R01NS052619 ( U.S. NIH Grant/Contract )
First Submitted: February 4, 2008
First Posted: February 6, 2008
Results First Submitted: December 7, 2015
Results First Posted: March 30, 2016
Last Update Posted: March 30, 2016