Effects of Coenzyme Q10 (CoQ) in Parkinson Disease (QE3)

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: NCT00740714

Recruitment Status : Terminated (The investigational drug is unlikely to demonstrate efficacy over placebo for this indication. However, no safety issues were discovered.)

First Posted : August 25, 2008

Results First Posted : January 31, 2013

Last Update Posted : January 31, 2013

Sponsor:

Collaborators:

National Institute of Neurological Disorders and Stroke (NINDS)

University of Rochester

Information provided by (Responsible Party):

Weill Medical College of Cornell University

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Parkinson Disease
Interventions	Drug: Coenzyme Q10 with vitamin E Drug: placebo with vitamin E
Enrollment	600

Participant Flow

Recruitment Details	The recruitment period for the required 600 patients was from January 2009 to October 2010. There were 67 sites (60 in the US and 7 in Canada) that participated in the study. Most of these sites were located at or affiliated with large academic medical centers.
Pre-assignment Details	Patients were required to undergo a thorough screening visit. If patients were taking CoEnzyme Q10 but otherwise eligible for assignment, they were asked to return after a wash out period of 60 to 120 days based on daily dosage.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Period Title: Overall Study
Started	196 ^[1]	201 ^[1]	203 ^[1]
Reaching Endpoint Before May 6, 2011	86	87	94
Active Patients at Study Termination	24	12	33
Completed	179	182	174
Not Completed	17	19	29
Reason Not Completed
Withdrawal by Subject	17	19	29
[1] Randomized throughout the recruitment period

Baseline Characteristics

Arm/Group Title		A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day	Total
Arm/Group Description		Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...	Total of all reporting groups
Arm/Group Description		Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)	Total of all reporting groups
Overall Number of Baseline Participants		196	201	203	600
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	196 participants	201 participants	203 participants	600 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	113 57.7%	113 56.2%	133 65.5%	359 59.8%
	>=65 years	83 42.3%	88 43.8%	70 34.5%	241 40.2%
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	196 participants	201 participants	203 participants	600 participants
		62.8 (9.66)	63.3 (9.83)	61.3 (10.5)	62.5 (10.03)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	196 participants	201 participants	203 participants	600 participants
	Female	68 34.7%	62 30.8%	73 36.0%	203 33.8%
	Male	128 65.3%	139 69.2%	130 64.0%	397 66.2%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	196 participants	201 participants	203 participants	600 participants
United States		165	171	174	510
Canada		31	30	29	90

Outcome Measures

1.Primary Outcome


Title	Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))
Description	Outcome is defined as change in total Unified Parkinson's Disease Rati...
Description	Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176.
Time Frame	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Outcome Measure Data

Analysis Population Description

Eligible research participants were assigned by randomization to one of three treatment groups: CoQ10 2400 mg/day, CoQ10 1200 mg/day or matching placebo. All participants also received 1200 IU of vitamin E daily.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	8.01 (.63)	7.50 (.62)	6.92 (.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	ANCOVA is used with the change in total UPDRS of Coenzyme Q10 1200 mg/day arm compared to placebo group.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	>0.025
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	.59
	Confidence Interval	(2-Sided) 97.5% -1.33 to 2.51
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.85
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	ANCOVA is used with the change in total UPDRS of Coenzyme Q10 2400 mg/day arm compared to placebo group.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	>0.025
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95% -0.85 to 3.03
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.86
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Change in Modified Schwab & England Independence Scale From Baseline to 16 Months
Description	This scale measures activities of daily living. This is an investigato...
Description	This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden).
Time Frame	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analyses.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	-4.94 (.62)	-4.29 (.62)	-4.07 (.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline Visit to 16-month visit on Modified Schwab & England will be analyzed using ANCOVA in the same way as for the primary outcome variable.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7943
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 97.5% -2.12 to 1.68
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.84
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline Visit to 16-month on Modified Schwab & England will be analyzed using ANCOVA in the same way as for the primary outcome variable.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.306
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.87
	Confidence Interval	95% -2.79 to 1.04
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.85
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Change in Modified Rankin Scale From Baseline to 16 Months
Description	The Modified Rankin Scale is a global functional health index with a s...
Description	The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention.
Time Frame	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analyses.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	.38 (.05)	.31 (.05)	.40 (.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline Visit to 16-month visit on Modified Rankin Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.1615
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 97.5% -0.25 to 0.06
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.06
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline Visit to 16-month visit on Modified Rankin will be analyzed using ANCOVA in the same way as for the primary outcome variable.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7627
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-Adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plats and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95% -0.17 to 0.13
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.07
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Change in PD Quality of Life Scale From Baseline to 16 Months
Description	The subject will complete a questionnaire that will evaluate how Parki...
Description	The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life.
Time Frame	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analyses.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	5.06 (.89)	6.12 (.87)	5.57 (.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6383
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.6383
	Confidence Interval	(2-Sided) 97.5% -2.10 to 3.21
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.18
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.667
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95% -3.20 to 2.17
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.19
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Change in Symbol Digit Modalities Test From Baseline to 16 Months
Description	The Symbol Digit Modalities Test screens cognitive impairment by using...
Description	The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome).
Time Frame	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analyses.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	-3.36 (1.40)	-0.49 (1.39)	-3.02 (1.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.671
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 97.5% -2.09 to 3.06
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.14
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.671
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.74
	Confidence Interval	(2-Sided) 95% -3.34 to 1.87
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.16
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Change in Hoehn & Yahr Score From Baseline to 16 Months
Description	The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease stag...
Description	The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided).
Time Frame	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analyses.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	.21 (0.03)	.20 (0.03)	.16 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline Visit to 16-month visit on Hoehn & Yahr Score will be analyzed using ANCOVA in the same way as for the primary outcome variable.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3445
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 97.5% -0.04 to 0.13
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.04
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	Change from Baseline visit to 16-month visit on Hoehn & Yahr will be analyzed using ANCOVA in the same way as for the primary outcome variable.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	.239
	Comments	The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided. with a Bonferroni-adjustd significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.
	Method	ANCOVA
	Comments	COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assess with scatter and residual plots and ITT.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.04
	Confidence Interval	95% -0.04 to 0.14
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.05
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	CoQ10 Levels in Plasma
Description	Based on samples analyzed to date
Description	Based on samples analyzed to date
Time Frame	Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Outcome Measure Data

Analysis Population Description

All participants have been included and data is based on samples analyzed to date.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Mean (Standard Deviation) Unit of Measure: ug/ml
1 month visit	3.55 (1.83)	2.57 (1.29)	.75 (.36)
8 month visit	3.32 (1.93)	2.67 (1.33)	1.07 (.83)
16 month visit	2.88 (2.02)	2.17 (1.18)	.63 (.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	The analysis will be using the actual change of plasma levels of CoQ10(from final visit to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for all treatment groups.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0577
	Comments	[Not Specified]
	Method	ANOVA
	Comments	The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.536
	Confidence Interval	(2-Sided) 95% -0.018 to 1.091
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.282
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day
	Comments	The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 2400 mg/day.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5889
	Comments	[Not Specified]
	Method	ANOVA
	Comments	The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.245
	Confidence Interval	(2-Sided) 95% -0.647 to 1.136
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.451
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day
	Comments	The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 1200 mg/day.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3006
	Comments	[Not Specified]
	Method	ANOVA
	Comments	The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.631
	Confidence Interval	(2-Sided) 95% -0.569 to 1.831
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.608
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	C. Placebo With Vitamin E 1200 IU/Day
	Comments	The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the placebo group.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.096
	Comments	[Not Specified]
	Method	ANOVA
	Comments	The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.

Method of Estimation	Estimation Parameter	Slope
	Estimated Value	2.126
	Confidence Interval	(2-Sided) 95% -0.382 to 4.633
	Parameter Dispersion	Type: Standard Error of the mean Value: 1.269
	Estimation Comments	[Not Specified]

8.Secondary Outcome


Title	Adverse Experiences: Back Pain
Description	Number of participants with back pain
Description	Number of participants with back pain
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	9	13	9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 95% 0.57 to 2.80
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0199
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

9.Secondary Outcome


Title	Adverse Experiences: Constipation
Description	Number of participants with constipation
Description	Number of participants with constipation
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	7	13	7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subject experiencing a particular adverse experience
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.49
	Confidence Interval	(2-Sided) 95% 0.62 to 3.57
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0198
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

10.Secondary Outcome


Title	Adverse Experiences: Insomnia
Description	Number of participants with insomnia
Description	Number of participants with insomnia
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	6	13	6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.65
	Confidence Interval	(2-Sided) 95% 0.65 to 4.20
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0198
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

11.Secondary Outcome


Title	Adverse Experiences: Anxiety
Description	Number of participants with anxiety
Description	Number of participants with anxiety
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	12	13	14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95% 0.46 to 1.79
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0200
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

12.Secondary Outcome


Title	Adverse Experiences: Tremor
Description	Number of participants with tremor
Description	Number of participants with tremor
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	10	13	8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.50
	Confidence Interval	(2-Sided) 95% 0.66 to 3.41
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0199
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

13.Secondary Outcome


Title	Adverse Experiences: Nasopharyngitis
Description	Number of participants with nasopharyngitis
Description	Number of participants with nasopharyngitis
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	7	9	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.80
	Confidence Interval	(2-Sided) 95% 0.81 to 9.72
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0197
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

14.Secondary Outcome


Title	Adverse Experiences: Diarrhoea
Description	Number of participants with diarrhoea
Description	Number of participants with diarrhoea
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	6	9	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 95% 0.31 to 1.52
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0197
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

15.Secondary Outcome


Title	Adverse Experiences: Headache
Description	Number of participants with headache
Description	Number of participants with headache
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	9	8	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95% 0.36 to 1.70
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0197
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

16.Secondary Outcome


Title	Adverse Experiences: Urinary Tract Infection
Description	Number of patients with urinary tract infections
Description	Number of patients with urinary tract infections
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	6	8	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.44
	Confidence Interval	(2-Sided) 95% 0.69 to 8.58
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0197
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

17.Secondary Outcome


Title	Adverse Experiences: Nausea
Description	Number of participants with nausea
Description	Number of participants with nausea
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	7	7	10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95% 0.31 to 1.62
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0197
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

18.Secondary Outcome


Title	Adverse Experiences: Hypertension
Description	Number of participants with hypertension
Description	Number of participants with hypertension
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	5	7	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9999.98
	Confidence Interval	(2-Sided) 95% 2.77 to 9999.99
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0196
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

19.Secondary Outcome


Title	Adverse Experiences: Depression
Description	Number of participants with depression
Description	Number of participants with depression
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	9	6	14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95% 0.25 to 1.12
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0197
	Estimation Comments	Odds ration >1 indicates a higher frequency in active treatment group.

20.Secondary Outcome


Title	Adverse Experiences: Constipation: Moderate/Severe
Description	Number of participants with moderate/severe constipation
Description	Number of participants with moderate/severe constipation
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	3	10	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.26
	Confidence Interval	(2-Sided) 95% 0.64 to 8.01
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0196
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

21.Secondary Outcome


Title	Adverse Experiences: Anxiety: Moderate/Severe
Description	Number of participants with moderate/severe anxiety
Description	Number of participants with moderate/severe anxiety
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	9	9	7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95% 0.55 to 3.24
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0198
	Estimation Comments	Odds ratio of >1 indicates a higher frequency in active treatment group.

22.Secondary Outcome


Title	Adverse Experiences: Back Pain: Moderate/Severe
Description	Number of participants with moderate/severe back pain
Description	Number of participants with moderate/severe back pain
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	7	9	7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9999.98
	Confidence Interval	(2-Sided) 95% 0.48 to 9999.99
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0197
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

23.Secondary Outcome


Title	Adverse Experiences: Insomnia: Moderate/Severe
Description	Number of participants with moderate/severe insomnia
Description	Number of participants with moderate/severe insomnia
Time Frame	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Outcome Measure Data

Analysis Population Description

All participants were used in primary and secondary outcome analysis.


Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day	B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day	C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description:	Randomized to active treatment (Coe...	Randomized to active treatment (Coe...	Placebo (with vitamin E 1200 IU/day...
Arm/Group Description:	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Placebo (with vitamin E 1200 IU/day)
Overall Number of Participants Analyzed	196	201	203
Measure Type: Number Unit of Measure: participants
	2	9	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day, B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day, C. Placebo With Vitamin E 1200 IU/Day
	Comments	All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9999.98
	Confidence Interval	(2-Sided) 95% 2.51 to 9999.99
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.0196
	Estimation Comments	Odds ratio >1 indicates a higher frequency in active treatment group.

Adverse Events

Time Frame	Adverse events data were collected for a period of 2 years and 7 months.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day		B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day		C. Placebo With Vitamin E 1200 IU/Day
Arm/Group Description	Randomized to active treatment (Coe...		Randomized to active treatment (Coe...		Placebo (with vitamin E 1200 IU/day...
Arm/Group Description	Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)		Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)		Placebo (with vitamin E 1200 IU/day)
All-Cause Mortality
	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day		B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day		C. Placebo With Vitamin E 1200 IU/Day
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day		B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day		C. Placebo With Vitamin E 1200 IU/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/196 (3.57%)		13/201 (6.47%)		13/203 (6.40%)
Cardiac disorders
Chest pain ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	1
Myocardial infarction ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	0/203 (0.00%)	0
Atrial fibrillation ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	0/203 (0.00%)	0
Gastrointestinal disorders
Gastero-intestinal bleed ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	0/203 (0.00%)	0
Bowel obstruction ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	0/203 (0.00%)	0
Colon cancer ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	1
General disorders
Multiple myeloma ^† 1	1/196 (0.51%)	1	0/201 (0.00%)	0	0/203 (0.00%)	0
Pulmonary embolism ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	0/203 (0.00%)	0
Pneumonia ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	2/203 (0.99%)	2
Sudden death ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	0/203 (0.00%)	0
Dehydration ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	2
Subarachnoid hemorrhage ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	0/203 (0.00%)	0
Accident with fractures and head trauma ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	0/203 (0.00%)	0
Infections and infestations
Dental infection ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	1
Injury, poisoning and procedural complications
Accident with fractures ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	1/203 (0.49%)	1
Metabolism and nutrition disorders
Diabetes mellitus ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	0/203 (0.00%)	0
Musculoskeletal and connective tissue disorders
Rhabdomyolysis ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	1
Nervous system disorders
Cervical radiculopathy ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	1	0/203 (0.00%)	0
Back pain ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	1
Vertigo ^† 1	1/196 (0.51%)	1	0/201 (0.00%)	0	1/203 (0.49%)	1
Spinal stenosis ^† 1	1/196 (0.51%)	1	0/201 (0.00%)	0	0/203 (0.00%)	0
Psychiatric disorders
Depression ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	1
Renal and urinary disorders
Prostatitis ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	1
Prostate cancer progression ^† 1	1/128 (0.78%)	1	0/139 (0.00%)	0	0/130 (0.00%)	0
Benign prostatic hypertrophy ^† 1	0/128 (0.00%)	0	0/139 (0.00%)	0	1/130 (0.77%)	1
Reproductive system and breast disorders
Pelvic floor dysfunction ^† 1	0/68 (0.00%)	0	1/62 (1.61%)	1	0/73 (0.00%)	0
Breast cancer ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^† 1	0/196 (0.00%)	0	0/201 (0.00%)	0	1/203 (0.49%)	1
Hypersensitivity pneumonitis ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	2	0/203 (0.00%)	0
Surgical and medical procedures
Cardiac catheterization ^† 1	1/196 (0.51%)	1	0/0	0	1/203 (0.49%)	1
Pacemaker battery replacement ^† 1	2/196 (1.02%)	2	0/201 (0.00%)	0	0/203 (0.00%)	0
Total knee replacement ^† 1	0/196 (0.00%)	0	1/201 (0.50%)	2	1/203 (0.49%)	1
Gastric banding ^† 1	1/196 (0.51%)	1	0/201 (0.00%)	0	0/203 (0.00%)	0
Transurethral resection of the prostate ^† 1	0/128 (0.00%)	0	1/139 (0.72%)	1	0/130 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (11.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	3%
	A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day		B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day		C. Placebo With Vitamin E 1200 IU/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	106/196 (54.08%)		113/201 (56.22%)		108/203 (53.20%)
Gastrointestinal disorders
Constipation ^† 1	7/196 (3.57%)	7	13/201 (6.47%)	13	7/203 (3.45%)	7
Diarrhea ^† 1	6/196 (3.06%)	6	9/201 (4.48%)	9	11/203 (5.42%)	11
Nausea ^† 1	7/196 (3.57%)	7	7/201 (3.48%)	7	10/203 (4.93%)	10
General disorders
Insomnia ^† 1	6/196 (3.06%)	6	13/201 (6.47%)	13	6/203 (2.96%)	6
Nasopharyngitis ^† 1	7/196 (3.57%)	7	9/201 (4.48%)	9	3/203 (1.48%)	3
Headache ^† 1	9/196 (4.59%)	9	8/201 (3.98%)	8	11/203 (5.42%)	11
Injury, poisoning and procedural complications
Fall ^† 1	6/196 (3.06%)	6	6/201 (2.99%)	6	7/203 (3.45%)	7
Nervous system disorders
Back pain ^† 1	9/196 (4.59%)	9	13/201 (6.47%)	13	9/203 (4.43%)	9
Tremor ^† 1	10/196 (5.10%)	10	13/201 (6.47%)	13	8/203 (3.94%)	8
Dizziness ^† 1	7/196 (3.57%)	7	6/201 (2.99%)	6	5/203 (2.46%)	5
Psychiatric disorders
Anxiety ^† 1	12/196 (6.12%)	12	13/201 (6.47%)	13	14/203 (6.90%)	14
Depression ^† 1	9/196 (4.59%)	9	6/201 (2.99%)	6	14/203 (6.90%)	14
Renal and urinary disorders
Urinary tract infection ^† 1	6/196 (3.06%)	6	8/201 (3.98%)	8	3/203 (1.48%)	3
Vascular disorders
Hypertension ^† 1	5/196 (2.55%)	5	7/201 (3.48%)	7	0/203 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 10.0

Limitations and Caveats

The planned interim analysis for futility based on the first 300 subjects has reached the pre-specified termination criterion.

More Information

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:	M. Flint Beal, MD
Organization:	Weill Medical College of Cornell University
Phone:	212-746-6575
EMail:	fbeal@med.cornell.edu

Publications:

Beal MF, Henshaw DR, Jenkins BG, Rosen BR, Schulz JB. Coenzyme Q10 and nicotinamide block striatal lesions produced by the mitochondrial toxin malonate. Ann Neurol. 1994 Dec;36(6):882-8.

Beal MF, Matthews RT, Tieleman A, Shults CW. Coenzyme Q10 attenuates the 1-methyl-4-phenyl-1,2,3,tetrahydropyridine (MPTP) induced loss of striatal dopamine and dopaminergic axons in aged mice. Brain Res. 1998 Feb 2;783(1):109-14.

Beal MF. Energetics in the pathogenesis of neurodegenerative diseases. Trends Neurosci. 2000 Jul;23(7):298-304. Review.

Beal MF. Coenzyme Q10 as a possible treatment for neurodegenerative diseases. Free Radic Res. 2002 Apr;36(4):455-60. Review.

NINDS NET-PD Investigators. A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease. Neurology. 2007 Jan 2;68(1):20-8.

Ravina BM, Fagan SC, Hart RG, Hovinga CA, Murphy DD, Dawson TM, Marler JR. Neuroprotective agents for clinical trials in Parkinson's disease: a systematic assessment. Neurology. 2003 Apr 22;60(8):1234-40. Review.

Shoulson I, Oakes D, Fahn S, Lang A, Langston JW, LeWitt P, Olanow CW, Penney JB, Tanner C, Kieburtz K, Rudolph A; Parkinson Study Group. Impact of sustained deprenyl (selegiline) in levodopa-treated Parkinson's disease: a randomized placebo-controlled extension of the deprenyl and tocopherol antioxidative therapy of parkinsonism trial. Ann Neurol. 2002 May;51(5):604-12.

Shults CW, Haas RH, Passov D, Beal MF. Coenzyme Q10 levels correlate with the activities of complexes I and II/III in mitochondria from parkinsonian and nonparkinsonian subjects. Ann Neurol. 1997 Aug;42(2):261-4.

Shults CW, Beal MF, Fontaine D, Nakano K, Haas RH. Absorption, tolerability, and effects on mitochondrial activity of oral coenzyme Q10 in parkinsonian patients. Neurology. 1998 Mar;50(3):793-5.

Shults CW, Oakes D, Kieburtz K, Beal MF, Haas R, Plumb S, Juncos JL, Nutt J, Shoulson I, Carter J, Kompoliti K, Perlmutter JS, Reich S, Stern M, Watts RL, Kurlan R, Molho E, Harrison M, Lew M; Parkinson Study Group. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Arch Neurol. 2002 Oct;59(10):1541-50.

Shults CW. Coenzyme Q10 in neurodegenerative diseases. Curr Med Chem. 2003 Oct;10(19):1917-21. Review.

Shults CW, Flint Beal M, Song D, Fontaine D. Pilot trial of high dosages of coenzyme Q10 in patients with Parkinson's disease. Exp Neurol. 2004 Aug;188(2):491-4.

Lee IM, Cook NR, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE. Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial. JAMA. 2005 Jul 6;294(1):56-65.

Blatt DH, Pryor WA. High-dosage vitamin E supplementation and all-cause mortality. Ann Intern Med. 2005 Jul 19;143(2):150-1; author reply 156-8.

McDonald SR, Sohal RS, Forster MJ. Concurrent administration of coenzyme Q10 and alpha-tocopherol improves learning in aged mice. Free Radic Biol Med. 2005 Mar 15;38(6):729-36.

Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. Epub 2004 Nov 10.

Parkinson Study Group. Effects of tocopherol and deprenyl on the progression of disability in early Parkinson's disease. N Engl J Med. 1993 Jan 21;328(3):176-83.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Parkinson Study Group QE3 Investigators, Beal MF, Oakes D, Shoulson I, Henchcliffe C, Galpern WR, Haas R, Juncos JL, Nutt JG, Voss TS, Ravina B, Shults CM, Helles K, Snively V, Lew MF, Griebner B, Watts A, Gao S, Pourcher E, Bond L, Kompoliti K, Agarwal P, Sia C, Jog M, Cole L, Sultana M, Kurlan R, Richard I, Deeley C, Waters CH, Figueroa A, Arkun A, Brodsky M, Ondo WG, Hunter CB, Jimenez-Shahed J, Palao A, Miyasaki JM, So J, Tetrud J, Reys L, Smith K, Singer C, Blenke A, Russell DS, Cotto C, Friedman JH, Lannon M, Zhang L, Drasby E, Kumar R, Subramanian T, Ford DS, Grimes DA, Cote D, Conway J, Siderowf AD, Evatt ML, Sommerfeld B, Lieberman AN, Okun MS, Rodriguez RL, Merritt S, Swartz CL, Martin WR, King P, Stover N, Guthrie S, Watts RL, Ahmed A, Fernandez HH, Winters A, Mari Z, Dawson TM, Dunlop B, Feigin AS, Shannon B, Nirenberg MJ, Ogg M, Ellias SA, Thomas CA, Frei K, Bodis-Wollner I, Glazman S, Mayer T, Hauser RA, Pahwa R, Langhammer A, Ranawaya R, Derwent L, Sethi KD, Farrow B, Prakash R, Litvan I, Robinson A, Sahay A, Gartner M, Hinson VK, Markind S, Pelikan M, Perlmutter JS, Hartlein J, Molho E, Evans S, Adler CH, Duffy A, Lind M, Elmer L, Davis K, Spears J, Wilson S, Leehey MA, Hermanowicz N, Niswonger S, Shill HA, Obradov S, Rajput A, Cowper M, Lessig S, Song D, Fontaine D, Zadikoff C, Williams K, Blindauer KA, Bergholte J, Propsom CS, Stacy MA, Field J, Mihaila D, Chilton M, Uc EY, Sieren J, Simon DK, Kraics L, Silver A, Boyd JT, Hamill RW, Ingvoldstad C, Young J, Thomas K, Kostyk SK, Wojcieszek J, Pfeiffer RF, Panisset M, Beland M, Reich SG, Cines M, Zappala N, Rivest J, Zweig R, Lumina LP, Hilliard CL, Grill S, Kellermann M, Tuite P, Rolandelli S, Kang UJ, Young J, Rao J, Cook MM, Severt L, Boyar K. A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit. JAMA Neurol. 2014 May;71(5):543-52. doi: 10.1001/jamaneurol.2014.131.

Layout table for additonal information

Responsible Party:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00740714
Other Study ID Numbers:	U01NS050324 ( U.S. NIH Grant/Contract ) U01NS050573 ( U.S. NIH Grant/Contract )
First Submitted:	August 22, 2008
First Posted:	August 25, 2008
Results First Submitted:	July 24, 2012
Results First Posted:	January 31, 2013
Last Update Posted:	January 31, 2013

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