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Trial record 2 of 2 for:    12069110 [PUBMED-IDS]

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
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
Hide 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
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
Hide 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
Hide 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
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))
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Show Statistical Analysis 1 Hide 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]
Show Statistical Analysis 2 Hide 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]
Show Statistical Analysis 3 Hide 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]
Show Statistical Analysis 4 Hide 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
Hide Description Number of participants with back pain
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with constipation
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with insomnia
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with anxiety
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with tremor
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with nasopharyngitis
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with diarrhoea
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with headache
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of patients with urinary tract infections
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with nausea
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with hypertension
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with depression
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with moderate/severe constipation
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with moderate/severe anxiety
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with moderate/severe back pain
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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
Hide Description Number of participants with moderate/severe insomnia
Time Frame Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Hide Outcome Measure Data
Hide 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
Hide 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
Show Statistical Analysis 1 Hide 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.
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
Hide 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   --/--      --/--      --/--    
Show Serious Adverse Events Hide 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)
Show Other (Not Including Serious) Adverse Events Hide 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
The planned interim analysis for futility based on the first 300 subjects has reached the pre-specified termination criterion.
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:
Miller E. R., Appel L. J., Guallar E., and Pastor-Barriuso R. High-Dosage Vitamin E Supplementation and All-Cause Mortality. Ann Intern Med. 2005b, 143:156-158.
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     History of Changes
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