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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
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
C. Placebo With Vitamin E 1200 IU/Day Placebo (with vitamin E 1200 IU/day)

Participant Flow:   Overall Study
    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
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 
Withdrawal by Subject                17                19                29 
[1] Randomized throughout the recruitment period



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
C. Placebo With Vitamin E 1200 IU/Day Placebo (with vitamin E 1200 IU/day)
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 		 196   201   203   600 
Age 
[Units: Participants]
 		       
<=18 years   0   0   0   0 
Between 18 and 65 years   113   113   133   359 
>=65 years   83   88   70   241 
Age 
[Units: Years]
Mean (Standard Deviation) 		 62.8  (9.66)   63.3  (9.83)   61.3  (10.5)   62.5  (10.03) 
Gender 
[Units: Participants]
 		       
Female   68   62   73   203 
Male   128   139   130   397 
Region of Enrollment 
[Units: Participants]
 		       
United States   165   171   174   510 
Canada   31   30   29   90 


  Outcome Measures

1.  Primary:   Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))   [ Time Frame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first ]
  Show Outcome Measure 1

2.  Secondary:   Change in Modified Schwab & England Independence Scale From Baseline to 16 Months   [ Time Frame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first ]
  Show Outcome Measure 2

3.  Secondary:   Change in Modified Rankin Scale From Baseline to 16 Months   [ Time Frame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first ]
  Show Outcome Measure 3

4.  Secondary:   Change in PD Quality of Life Scale From Baseline to 16 Months   [ Time Frame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first ]
  Show Outcome Measure 4

5.  Secondary:   Change in Symbol Digit Modalities Test From Baseline to 16 Months   [ Time Frame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first ]
  Show Outcome Measure 5

6.  Secondary:   Change in Hoehn & Yahr Score From Baseline to 16 Months   [ Time Frame: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first ]
  Show Outcome Measure 6

7.  Secondary:   CoQ10 Levels in Plasma   [ Time Frame: Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first ]
  Show Outcome Measure 7

8.  Secondary:   Adverse Experiences: Back Pain   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 8

9.  Secondary:   Adverse Experiences: Constipation   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 9

10.  Secondary:   Adverse Experiences: Insomnia   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 10

11.  Secondary:   Adverse Experiences: Anxiety   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 11

12.  Secondary:   Adverse Experiences: Tremor   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 12

13.  Secondary:   Adverse Experiences: Nasopharyngitis   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 13

14.  Secondary:   Adverse Experiences: Diarrhoea   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 14

15.  Secondary:   Adverse Experiences: Headache   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 15

16.  Secondary:   Adverse Experiences: Urinary Tract Infection   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 16

17.  Secondary:   Adverse Experiences: Nausea   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 17

18.  Secondary:   Adverse Experiences: Hypertension   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 18

19.  Secondary:   Adverse Experiences: Depression   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 19

20.  Secondary:   Adverse Experiences: Constipation: Moderate/Severe   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 20

21.  Secondary:   Adverse Experiences: Anxiety: Moderate/Severe   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 21

22.  Secondary:   Adverse Experiences: Back Pain: Moderate/Severe   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 22

23.  Secondary:   Adverse Experiences: Insomnia: Moderate/Severe   [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
  Show Outcome Measure 23


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: M. Flint Beal, MD
Organization: Weill Medical College of Cornell University
phone: 212-746-6575
e-mail: 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.


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