Effects of Coenzyme Q10 (CoQ) in Parkinson Disease (QE3)
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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
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Sponsor:
Weill Medical College of Cornell University
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Information provided by (Responsible Party):
Weill Medical College of Cornell University
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Study Type | Interventional |
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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 |
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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
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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 | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 196 participants | 201 participants | 203 participants | 600 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
113 57.7%
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113 56.2%
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133 65.5%
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359 59.8%
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>=65 years |
83 42.3%
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88 43.8%
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70 34.5%
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241 40.2%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 196 participants | 201 participants | 203 participants | 600 participants | |
Female |
68 34.7%
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62 30.8%
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73 36.0%
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203 33.8%
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Male |
128 65.3%
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139 69.2%
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130 64.0%
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397 66.2%
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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
Adverse Events
Limitations and Caveats
The planned interim analysis for futility based on the first 300 subjects has reached the pre-specified termination criterion.
More Information
Results Point of Contact
Name/Title: | M. Flint Beal, MD |
Organization: | Weill Medical College of Cornell University |
Phone: | 212-746-6575 |
EMail: | fbeal@med.cornell.edu |
Publications:
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 |