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

This study has been terminated.
(The investigational drug is unlikely to demonstrate efficacy over placebo for this indication. However, no safety issues were discovered.)
Sponsor:
Collaborators:
University of Rochester
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00740714
First received: August 22, 2008
Last updated: December 24, 2012
Last verified: December 2012
Results First Received: July 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Drug: Coenzyme Q10 with vitamin E
Drug: placebo with vitamin E

  Participant Flow
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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
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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  
Number of Participants  
[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
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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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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:
Shoulson, I, et al. Impact of sustained deprenyl (selegiline) in levodopa-treated Parkinson disease: A randomized, placebo-controlled extension of the deprenyl and tocopherol antioxidative therapy of parkinsonism trial. Annals of Neurology, 2002; 51:124-35.
Shults CW. CoQ in neurodegenerative diseases. Curr Med Chem 2003; 10(19):1917-21.

Publications automatically indexed to this study:
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, U01NS050573
Study First Received: August 22, 2008
Results First Received: July 24, 2012
Last Updated: December 24, 2012
Health Authority: United States: Food and Drug Administration