Coenzyme Q10 in Huntington's Disease (HD)

NCT00608881, Phase 3, Terminated, Massachusetts General Hospital; results first posted 2016-03-30

Trial 12

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Coenzyme Q10 in Huntington's Disease (HD)	ClinicalTrials.gov
NCT number	NCT00608881	ClinicalTrials.gov
Status	Terminated	ClinicalTrials.gov
Phases	Phase 3	ClinicalTrials.gov
Enrollment	609 participants, actual	ClinicalTrials.gov
Lead sponsor	Massachusetts General Hospital	ClinicalTrials.gov
Conditions	Huntington's Disease	ClinicalTrials.gov
Interventions	coenzyme Q10, placebo	ClinicalTrials.gov
First posted	2008-02-06	ClinicalTrials.gov
Last updated	2016-03-30	ClinicalTrials.gov
Results first posted	2016-03-30	ClinicalTrials.gov
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.	ClinicalTrials.gov

Registered outcomes 15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	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))	5 years	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).	ClinicalTrials.gov
Secondary	Change in Total Functional Capacity (TFC) Score From Baseline to Month 60	Baseline and 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).	ClinicalTrials.gov
Secondary	Change in Functional Checklist Score From Baseline to Month 60	Baseline and 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.	ClinicalTrials.gov
Secondary	Change in Independence Scale Score From Baseline to Month 60	Baseline and Month 60	The independence scale assesses independence on a 0 to 100 scale with higher scores indicating better functioning.	ClinicalTrials.gov
Secondary	Change in Total Motor Score From Baseline to Month 60	Baseline and 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.	ClinicalTrials.gov
Secondary	Change in Behavioral Frequency Score From Baseline to Month 60	Baseline and 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.	ClinicalTrials.gov
Secondary	Change in Behavioral Frequency x Severity Score From Baseline to Month 60	Baseline and 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.	ClinicalTrials.gov
Secondary	Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60	Baseline and 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.	ClinicalTrials.gov
Secondary	Change in Verbal Fluency Test From Baseline to Month 60	Baseline and 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.	ClinicalTrials.gov
Secondary	Change in Stroop Interference Test - Color Naming From Baseline to Month 60	Baseline and Month 60	Stroop Interference Test - color naming score is the total number of correct colors identified in 45 seconds and reflects processing speed.	ClinicalTrials.gov
Secondary	Change in Stroop Interference Test - Word Reading From Baseline to Month 60	Baseline and Month 60	Stroop Interference Test - word reading score is the total number of correct words read in 45 seconds and reflects processing speed.	ClinicalTrials.gov
Secondary	Change in Stroop Interference Test - Interference From Baseline to Month 60	Baseline and 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.	ClinicalTrials.gov
Secondary	Time to a Two-Point Decline in TFC Score or Death	5 years	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).	ClinicalTrials.gov
Secondary	Time to a Three-Point Decline in TFC Score or Death	5 years	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).	ClinicalTrials.gov
Secondary	Number Completing Study at Assigned Dosage Level	5 years		ClinicalTrials.gov

Outcomes 15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as	Source
PRIMARY	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))	5 years	rank	MEAN	ClinicalTrials.gov
SECONDARY	Change in Total Functional Capacity (TFC) Score From Baseline to Month 60	Baseline and Month 60	units on a scale	LEAST_SQUARES_MEAN	ClinicalTrials.gov
SECONDARY	Change in Functional Checklist Score From Baseline to Month 60	Baseline and Month 60	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Independence Scale Score From Baseline to Month 60	Baseline and Month 60	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Total Motor Score From Baseline to Month 60	Baseline and Month 60	units on a scale	LEAST_SQUARES_MEAN	ClinicalTrials.gov
SECONDARY	Change in Behavioral Frequency Score From Baseline to Month 60	Baseline and Month 60	units on a scale	LEAST_SQUARES_MEAN	ClinicalTrials.gov
SECONDARY	Change in Behavioral Frequency x Severity Score From Baseline to Month 60	Baseline and Month 60	units on a scale	LEAST_SQUARES_MEAN	ClinicalTrials.gov
SECONDARY	Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60	Baseline and Month 60	units on a scale	LEAST_SQUARES_MEAN	ClinicalTrials.gov
SECONDARY	Change in Verbal Fluency Test From Baseline to Month 60	Baseline and Month 60	units on a scale	LEAST_SQUARES_MEAN	ClinicalTrials.gov
SECONDARY	Change in Stroop Interference Test - Color Naming From Baseline to Month 60	Baseline and Month 60	units on a scale	LEAST_SQUARES_MEAN	ClinicalTrials.gov
SECONDARY	Change in Stroop Interference Test - Word Reading From Baseline to Month 60	Baseline and Month 60	units on a scale	LEAST_SQUARES_MEAN	ClinicalTrials.gov
SECONDARY	Change in Stroop Interference Test - Interference From Baseline to Month 60	Baseline and Month 60	units on a scale	LEAST_SQUARES_MEAN	ClinicalTrials.gov
SECONDARY	Time to a Two-Point Decline in TFC Score or Death	5 years	days to event	MEDIAN	ClinicalTrials.gov
SECONDARY	Time to a Three-Point Decline in TFC Score or Death	5 years	days to event	MEDIAN	ClinicalTrials.gov
SECONDARY	Number Completing Study at Assigned Dosage Level	5 years	participants completing study on drug	NUMBER	ClinicalTrials.gov

Results by group 30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units	Source
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))	A - Coenzyme Q10 2400 mg/Day	303.3	Standard Deviation 173.1	rank	ClinicalTrials.gov
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))	B - Placebo	306.7	Standard Deviation 179.0	rank	ClinicalTrials.gov
Change in Total Functional Capacity (TFC) Score From Baseline to Month 60	A - Coenzyme Q10 2400 mg/Day	-4.53	Standard Error 0.25	units on a scale	ClinicalTrials.gov
Change in Total Functional Capacity (TFC) Score From Baseline to Month 60	B - Placebo	-4.76	Standard Error 0.24	units on a scale	ClinicalTrials.gov
Change in Functional Checklist Score From Baseline to Month 60	A - Coenzyme Q10 2400 mg/Day	-7.93	Standard Error 0.55	units on a scale	ClinicalTrials.gov
Change in Functional Checklist Score From Baseline to Month 60	B - Placebo	-8.02	Standard Error 0.54	units on a scale	ClinicalTrials.gov
Change in Independence Scale Score From Baseline to Month 60	A - Coenzyme Q10 2400 mg/Day	-26.30	Standard Error 1.92	units on a scale	ClinicalTrials.gov
Change in Independence Scale Score From Baseline to Month 60	B - Placebo	-24.86	Standard Error 1.90	units on a scale	ClinicalTrials.gov
Change in Total Motor Score From Baseline to Month 60	A - Coenzyme Q10 2400 mg/Day	18.06	Standard Error 1.22	units on a scale	ClinicalTrials.gov
Change in Total Motor Score From Baseline to Month 60	B - Placebo	19.18	Standard Error 1.18	units on a scale	ClinicalTrials.gov
Change in Behavioral Frequency Score From Baseline to Month 60	A - Coenzyme Q10 2400 mg/Day	1.39	Standard Error 0.55	units on a scale	ClinicalTrials.gov
Change in Behavioral Frequency Score From Baseline to Month 60	B - Placebo	1.43	Standard Error 0.53	units on a scale	ClinicalTrials.gov
Change in Behavioral Frequency x Severity Score From Baseline to Month 60	A - Coenzyme Q10 2400 mg/Day	4.29	Standard Error 1.52	units on a scale	ClinicalTrials.gov
Change in Behavioral Frequency x Severity Score From Baseline to Month 60	B - Placebo	5.06	Standard Error 1.46	units on a scale	ClinicalTrials.gov
Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60	A - Coenzyme Q10 2400 mg/Day	-10.95	Standard Error 0.66	units on a scale	ClinicalTrials.gov
Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60	B - Placebo	-11.36	Standard Error 0.65	units on a scale	ClinicalTrials.gov
Change in Verbal Fluency Test From Baseline to Month 60	A - Coenzyme Q10 2400 mg/Day	-5.07	Standard Error 0.79	units on a scale	ClinicalTrials.gov
Change in Verbal Fluency Test From Baseline to Month 60	B - Placebo	-4.47	Standard Error 0.78	units on a scale	ClinicalTrials.gov
Change in Stroop Interference Test - Color Naming From Baseline to Month 60	A - Coenzyme Q10 2400 mg/Day	-14.21	Standard Error 1.00	units on a scale	ClinicalTrials.gov
Change in Stroop Interference Test - Color Naming From Baseline to Month 60	B - Placebo	-14.51	Standard Error 0.97	units on a scale	ClinicalTrials.gov

Participant flow 6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	A - Coenzyme Q10 2400 mg/Day	303	ClinicalTrials.gov
Overall Study	STARTED	B - Placebo	306	ClinicalTrials.gov
Overall Study	COMPLETED	A - Coenzyme Q10 2400 mg/Day	224	ClinicalTrials.gov
Overall Study	COMPLETED	B - Placebo	240	ClinicalTrials.gov
Overall Study	NOT COMPLETED	A - Coenzyme Q10 2400 mg/Day	79	ClinicalTrials.gov
Overall Study	NOT COMPLETED	B - Placebo	66	ClinicalTrials.gov

Adverse events 308

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Source
other	CONSTIPATION	Gastrointestinal disorders	A - Coenzyme Q10 2400 mg/Day	26	303	ClinicalTrials.gov
other	CONSTIPATION	Gastrointestinal disorders	B - Placebo	22	306	ClinicalTrials.gov
other	DIARRHOEA	Gastrointestinal disorders	A - Coenzyme Q10 2400 mg/Day	36	303	ClinicalTrials.gov
other	DIARRHOEA	Gastrointestinal disorders	B - Placebo	43	306	ClinicalTrials.gov
other	DYSPHAGIA	Gastrointestinal disorders	A - Coenzyme Q10 2400 mg/Day	25	303	ClinicalTrials.gov
other	DYSPHAGIA	Gastrointestinal disorders	B - Placebo	21	306	ClinicalTrials.gov
other	NAUSEA	Gastrointestinal disorders	A - Coenzyme Q10 2400 mg/Day	31	303	ClinicalTrials.gov
other	NAUSEA	Gastrointestinal disorders	B - Placebo	24	306	ClinicalTrials.gov
other	VOMITING	Gastrointestinal disorders	A - Coenzyme Q10 2400 mg/Day	25	303	ClinicalTrials.gov
other	VOMITING	Gastrointestinal disorders	B - Placebo	23	306	ClinicalTrials.gov
other	FATIGUE	General disorders	A - Coenzyme Q10 2400 mg/Day	19	303	ClinicalTrials.gov
other	FATIGUE	General disorders	B - Placebo	16	306	ClinicalTrials.gov
other	BRONCHITIS	Infections and infestations	A - Coenzyme Q10 2400 mg/Day	16	303	ClinicalTrials.gov
other	BRONCHITIS	Infections and infestations	B - Placebo	19	306	ClinicalTrials.gov
other	INFLUENZA	Infections and infestations	A - Coenzyme Q10 2400 mg/Day	21	303	ClinicalTrials.gov
other	INFLUENZA	Infections and infestations	B - Placebo	17	306	ClinicalTrials.gov
other	NASOPHARYNGITIS	Infections and infestations	A - Coenzyme Q10 2400 mg/Day	27	303	ClinicalTrials.gov
other	NASOPHARYNGITIS	Infections and infestations	B - Placebo	34	306	ClinicalTrials.gov
other	SINUSITIS	Infections and infestations	A - Coenzyme Q10 2400 mg/Day	14	303	ClinicalTrials.gov
other	SINUSITIS	Infections and infestations	B - Placebo	19	306	ClinicalTrials.gov

Adverse event totals 6

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	A - Coenzyme Q10 2400 mg/Day			ClinicalTrials.gov
Total, all-cause mortality	B - Placebo			ClinicalTrials.gov
Total, other adverse events	A - Coenzyme Q10 2400 mg/Day	276	303	ClinicalTrials.gov
Total, other adverse events	B - Placebo	280	306	ClinicalTrials.gov
Total, serious adverse events	A - Coenzyme Q10 2400 mg/Day	76	303	ClinicalTrials.gov
Total, serious adverse events	B - Placebo	83	306	ClinicalTrials.gov

Papers 64

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
153122	BACKGROUND	PubMed
154626	BACKGROUND	PubMed
1479606	BACKGROUND	PubMed
1535611	BACKGROUND	PubMed
1637852	BACKGROUND	PubMed
1832854	BACKGROUND	PubMed
2139171	BACKGROUND	PubMed
2202752	BACKGROUND	PubMed
2299344	BACKGROUND	PubMed
2524678	BACKGROUND	PubMed
2534934	BACKGROUND	PubMed
2928337	BACKGROUND	PubMed
2935747	BACKGROUND	PubMed
2945510	BACKGROUND	PubMed
2973230	BACKGROUND	PubMed
4244787	BACKGROUND	PubMed
6225033	BACKGROUND	PubMed
6233902	BACKGROUND	PubMed
7599208	BACKGROUND	PubMed
7624378	BACKGROUND	PubMed

Grants 2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
R01NS052619	Coordination and Statistics for Coenzyme Q10 in Huntington's Disease	MCDERMOTT, MICHAEL P	UNIVERSITY OF ROCHESTER	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2005 to 2014	NIH RePORTER
U01NS052592	Coenzyme Q10 in Huntingtons Disease	CUDKOWICZ, MERIT E	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2008 to 2013	NIH RePORTER

Trial comparisons 1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
A - Coenzyme Q10 2400 mg/Day vs B - Placebo: serious adverse events	Trial comparisons

Tests 3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Stroop Color-Word Test	Secondary outcome	ConductCognition
Symbol Coding	Secondary outcome	ConductCognition
Verbal Fluency	Secondary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)