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

Effects of Coenzyme Q10 in Parkinson Disease - Phase III

The purpose of this study is to evaluate the safety and effectiveness of high dosages of Coenzyme Q10 in slowing clinical decline in people who have early Parkinson disease.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Coenzyme Q10 with vitamin E; Drug: placebo with vitamin E

Detailed Description

Parkinson disease (PD) is a progressive neurodegenerative disease that affects more than 1,000,000 Americans. Currently there is no proven therapy to reduce the rate of progression of PD. In a previous phase II clinical trial, investigators demonstrated that Coenzyme Q10 (CoQ) at dosages of 300, 600, and 1200 mg/day was safe and well-tolerated in individuals with early, untreated PD. The findings also suggested that CoQ may slow the progressive impairment of PD as measured by the Unified Parkinson Disease Rating Scale (UPDRS).

In this study, researchers will conduct a randomized, placebo-controlled, phase III trial of CoQ to confirm and extend the results of the earlier phase II study. The primary objective of this trial is to compare the effect of two dosages of CoQ (1200 and 2400 mg/day) and placebo on the total UPDRS score in people with early PD. The study also will evaluate independent function, cognition, and quality of life. Plasma CoQ levels will be measured at months 1, 8 and 16 and correlated with changes in UPDRS scores.

Participants will be randomly assigned to receive a placebo (an inactive substance), 1200 mg/d CoQ, or 2400 mg/d CoQ. They will be evaluated at screening, baseline, and during visits at months 1, 4, 8, 12, and 16. Information gained from this trial could lead to changes in management of people with early PD.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1R 3X5
    • Quebec Memory and Motor Skills Dis Clinic, Price Building 3Rd Floor, 65 Sainte-Anne Street
  • Alberta
    • Calgary, Alberta, Canada, T2N4NI
      • Un of Calgary Movement Disorders Program, Dept of Clin Neurosciences Area 3 Neurology, 3350 Hospital Dr NW Health Sciences Centre
    • Edmonton, Alberta, Canada, T5G 0B7
      • University of Alberta Glenrose Rehab Hosp, Rm 0601 Glen East, 10230 - 111 Avenue
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre, University Campus Room 10N29, 339 Windermere Road
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital-Civic Campus, 1053 Carling Avenue C2 Room 2210
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital, Univ Health Network, 399 Bathurst Street Mc 7-402, Movement Disorders Centre
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM-HOPITAL NOTRE DAME, 1560 rue SHERBROOKE est ROOM GR 1185, PAVILLON DECHAMPS etage rez-de-chaussee
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • University of Sherbrooke, 3001 12E Avenue Nord
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N OW8
      • Royal University Hospital, 103 Hospital Drive, Room 1663
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720
    • Scottsdale, Arizona, United States, 85260
      • Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B
    • Sun City, Arizona, United States, 85351
      • Sunhealth Research Institute, 10515 West Santa Fe Drive
  • California
    • Fountain Valley, California, United States, 92708
      • The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204
    • Irvine, California, United States, 92697-4275
      • University of California Irvine, 100 Irvine Hall
    • La Jolla, California, United States, 92093-0948
      • University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive
    • Los Angeles, California, United States, 900095
      • UCLA Medical Center, 710 Westwood Plaza, A-253
    • Sacramento, California, United States, 95817
      • UC Davis Dept of Neurology, 4860 Y Street, Suite 3700
    • Sunnyvale, California, United States, 94085
      • The Parkinson's Institute, 675 ALMANOR AVENUE
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Department of Neurology/Mail Stop B185, 12631 East 17Th Avenue Room 5209, Academic Office 1 Po Box 6511
    • Littleton, Colorado, United States, 80113
      • Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • The Institute For Neurodegenerative Disorders, 60 Temple Street, Suite 8B
  • Florida
    • Gainsville, Florida, United States, 32610-5806
      • University of Florida, McKnight Brain Institute Po Box 100236, 100 S Newell Drive L3-100
    • Miami, Florida, United States, 33136
      • University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5
    • Tampa, Florida, United States, 33606
      • University of South Florida, 4 Columbia Drive, Suite 410
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University School of Medicine, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
    • Augusta, Georgia, United States, 30912
      • Movement Disorders Program, Department of Neurology, Medical College of Georgia
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, 710 North Lake Shore Drive
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center Department of Neurological Sciences, 1725 West Harrison Suite 755
    • Chicago, Illinois, United States, 60637
      • University of Chicago, 5841 South Maryland Avenue, Mc2030
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals, 2133 Rcp Department of Neurology, 200 Hawkins Drive
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center, Department of Neurology Ms #2012, 3599 Rainbow Boulevard
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, Movement Disorder Clinic, Frazier Rehab, 220 Abraham Flexner, Suite 606
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept of Neurology 7Th Floor
    • Shreveport, Louisiana, United States, 71103
      • Lsuhsc Shreveport, Department of Neurology, 1501 Kings Highway Room 3-436
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B
    • Baltimore, Maryland, United States, 21287-0875
      • Johns Hopkins, 601 North Caroline Street, Suite 5064
    • Elkridge, Maryland, United States, 21075
      • Parkinson & Movement Dis Center If Maryland, 8180 Lark Brown Road, Suite 101
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center, Department of Neurology, 715 Albany Street C329
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Shapiro 809D
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota, 420 Delaware Street SE, Mmc 295
  • Missouri
    • St Louis, Missouri, United States, 63110-1093
      • Washington University School of Medicine, 660 South Euclid, Box 8111
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr, 47 New Scottland Avenue
    • Bronx, New York, United States, 10461
      • JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S
    • Brooklyn, New York, United States, 11203
      • Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213
    • Manhasset, New York, United States, 11030
      • Northshore-Lij Health System, the Feinstein Institute Fpr Medical Research, 350 Community Drive Room 100
    • New York, New York, United States, 10021
      • Weill Medical College of Cornell
    • New York, New York, United States, 10003
      • Beth Israel Medical Center, 10 Union Square East, Suite 5Hh2
    • New York, New York, United States, 10003
      • Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Room 5Ho1
    • New York, New York, United States, 10021
      • Parkinson'S Dis & Movement Disorders Inst, 428 East 72Nd Street, Suite 400
    • New York, New York, United States, 10032
      • Columbia University, 710 West 168Th Street, 3Rd Floor
    • Rochester, New York, United States, 14618
      • University of Rochester Department of Neurology, 919 Westfall Road Building C Suite 220
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University Neurology Inc., 222 Piedmont Avenue, Suite 3200
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center, 1581 Dodd Drive, 371 McCampbell Hall
    • Toledo, Ohio, United States, 43614
      • University of Toledo , 3000 Arlington Avenue , Mail Stop 1195
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health & Science University, Dept of Neurology, 3181 SW Sam Jackson Park Road Op-32
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S Hershey Med Center, Department of Neurology Mc H109 Room 2846, 500 University Drive Po Box 850
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania, Pennsylvania Hospital Department of Neurology, 330 South 9Th Street
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Neurohealth Parkinson'S Disease, Movement Disorder Center, 227 Centerville Road
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Medical University of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Semmes Murphey Clinic, 1211 Union Avenue, Suite 200
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Parkinson'S, Disease Center and Movement Disorders Clinic, 65501 Fannin St, Suite 1801
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont , Department of Neurology Given Building C-219 , 89 Beaumont Avenue
  • Washington
    • Kirkland, Washington, United States, 98034
      • Booth Gardner Parkinson'S Care Center, 13030 121St Way North East Suite 203
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-0099
      • Medical College of Wisconsin, Department of Neurology, 9200 West Wisconsin Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of all 3 of the cardinal features of Parkinson disease (resting tremor, bradykinesia and rigidity). The clinical signs must be asymmetric.
• The diagnosis of Parkinson disease within 5 years prior to the Screening Visit.
• Age 30 or older.
• Female subjects must not be of childbearing potential or must use an approved form of contraception for the duration of the trial.

Exclusion Criteria:

• Use of any Parkinson disease medication within 60 days prior to the Baseline Visit.
• Duration of previous use of symptomatic medication for Parkinson disease cannot exceed 90 days such as levodopa, dopaminergic agonists (including ropinirole, pramipexole, pergolide, cabergoline, and the rotigotine transdermal system), selegiline, rasagiline, amantadine, and anticholinergic agents.
• Parkinsonism due to drugs including neuroleptics, alphamethyldopa, reserpine, metoclopramide, valproic acid.
• Use of antioxidants (such as selegiline, rasagiline, vitamins E and C), additional supplemental vitamins or minerals, regular use of neuroleptics, chloramphenicol, valproic acid, warfarin.
• Other parkinsonian disorders.
• Modified Hoehn and Yahr score of 3 or greater at Screening Visit or Baseline Visit.
• UPDRS tremor score of 3 or greater at Screening Visit or Baseline Visit.
• Mini-Mental State Examination (MMSE) score of 25 or less.
• History of stroke.
• Disability sufficient to require treatment with dopaminergic medication or anticipated need for dopaminergic medication within next 3 months.
• Other serious illness, including psychiatric illness.
• Patients with active cardiovascular, peripheral vascular or cerebrovascular disease within the past year.
• Clinically serious abnormalities in the Screening Visit laboratory studies or electrocardiogram.
• Use of methylphenidate, cinnarizine, reserpine, amphetamine or a MAO-A inhibitor within 6 months prior to the Baseline Visit.
• Unstable dose of CNS active therapies.
• Use of appetite suppressants within 60 days prior to the Baseline Visit.
• History of active epilepsy within the last 5 years.
• Revised Hamilton Rating Scale for Depression of 11 or greater.
• Participation in other drug studies or use of other investigational drugs within 30 days prior to Screening Visit.
• History of electroconvulsive therapy.
• History of any brain surgery for Parkinson disease.
• History of structural brain disease such as prior trauma causing damage detected on a CT scan or MRI, hydrocephalus, or prior brain neoplasms.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)	Drug: Coenzyme Q10 with vitamin E; 2400 mg dose - eight 300 mg Coenzyme Q10 chewable wafers taken orally four times a day; 1200 mg dose - four 300 mg Coenzyme Q10 and four placebo chewable wafers taken orally four times a day.; Other Names: Coenzyme Q10, ubiquinone, ubidecarenone
Experimental: B; Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)	Drug: Coenzyme Q10 with vitamin E; 2400 mg dose - eight 300 mg Coenzyme Q10 chewable wafers taken orally four times a day; 1200 mg dose - four 300 mg Coenzyme Q10 and four placebo chewable wafers taken orally four times a day.; Other Names: Coenzyme Q10, ubiquinone, ubidecarenone
Placebo Comparator: C; Placebo (with vitamin E 1200 IU/day)	Drug: placebo with vitamin E; placebo or an inactive substance (with vitamin E 1200 IU/day); Placebo - eight chewable wafers taken orally four times a day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Schwab & England Independence Scale From Baseline to 16 Months	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).	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Change in Modified Rankin Scale From Baseline to 16 Months	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.	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Change in PD Quality of Life Scale From Baseline to 16 Months	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.	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Change in Symbol Digit Modalities Test From Baseline to 16 Months	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).	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Change in Hoehn & Yahr Score From Baseline to 16 Months	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).	Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
CoQ10 Levels in Plasma	Based on samples analyzed to date	Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first
Adverse Experiences: Back Pain	Number of participants with back pain	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Constipation	Number of participants with constipation	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Insomnia	Number of participants with insomnia	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Anxiety	Number of participants with anxiety	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Tremor	Number of participants with tremor	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Nasopharyngitis	Number of participants with nasopharyngitis	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Diarrhoea	Number of participants with diarrhoea	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Headache	Number of participants with headache	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Urinary Tract Infection	Number of patients with urinary tract infections	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Nausea	Number of participants with nausea	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Hypertension	Number of participants with hypertension	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Depression	Number of participants with depression	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Constipation: Moderate/Severe	Number of participants with moderate/severe constipation	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Anxiety: Moderate/Severe	Number of participants with moderate/severe anxiety	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Back Pain: Moderate/Severe	Number of participants with moderate/severe back pain	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)
Adverse Experiences: Insomnia: Moderate/Severe	Number of participants with moderate/severe insomnia	Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); University of Rochester
• Investigators: Principal Investigator: M. Flint Beal, MD, Weill Medical College of Cornell University, New York Hospital Department of Neurology; Principal Investigator: David Oakes, PhD, University of Rochester, Department of Biostatistics; Principal Investigator: Ira Shoulson, MD, University of Rochester, Clinical Trials Coordination Center

Publications and helpful links

General Publications

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• Beal MF. Energetics in the pathogenesis of neurodegenerative diseases. Trends Neurosci. 2000 Jul;23(7):298-304. doi: 10.1016/s0166-2236(00)01584-8.
• Shults CW, Oakes D, Kieburtz K, Beal MF, Haas R, Plumb S, Juncos JL, Nutt J, Shoulson I, Carter J, Kompoliti K, Perlmutter JS, Reich S, Stern M, Watts RL, Kurlan R, Molho E, Harrison M, Lew M; Parkinson Study Group. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline. Arch Neurol. 2002 Oct;59(10):1541-50. doi: 10.1001/archneur.59.10.1541.
• Beal MF. Coenzyme Q10 as a possible treatment for neurodegenerative diseases. Free Radic Res. 2002 Apr;36(4):455-60. doi: 10.1080/10715760290021315.
• Shults CW. Coenzyme Q10 in neurodegenerative diseases. Curr Med Chem. 2003 Oct;10(19):1917-21. doi: 10.2174/0929867033456882.
• Beal MF, Henshaw DR, Jenkins BG, Rosen BR, Schulz JB. Coenzyme Q10 and nicotinamide block striatal lesions produced by the mitochondrial toxin malonate. Ann Neurol. 1994 Dec;36(6):882-8. doi: 10.1002/ana.410360613.
• Beal MF, Matthews RT, Tieleman A, Shults CW. Coenzyme Q10 attenuates the 1-methyl-4-phenyl-1,2,3,tetrahydropyridine (MPTP) induced loss of striatal dopamine and dopaminergic axons in aged mice. Brain Res. 1998 Feb 2;783(1):109-14. doi: 10.1016/s0006-8993(97)01192-x.
• NINDS NET-PD Investigators. A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease. Neurology. 2007 Jan 2;68(1):20-8. doi: 10.1212/01.wnl.0000250355.28474.8e.
• Ravina BM, Fagan SC, Hart RG, Hovinga CA, Murphy DD, Dawson TM, Marler JR. Neuroprotective agents for clinical trials in Parkinson's disease: a systematic assessment. Neurology. 2003 Apr 22;60(8):1234-40. doi: 10.1212/01.wnl.0000058760.13152.1a.
• Shoulson I, Oakes D, Fahn S, Lang A, Langston JW, LeWitt P, Olanow CW, Penney JB, Tanner C, Kieburtz K, Rudolph A; Parkinson Study Group. Impact of sustained deprenyl (selegiline) in levodopa-treated Parkinson's disease: a randomized placebo-controlled extension of the deprenyl and tocopherol antioxidative therapy of parkinsonism trial. Ann Neurol. 2002 May;51(5):604-12. doi: 10.1002/ana.10191.
• Shults CW, Haas RH, Passov D, Beal MF. Coenzyme Q10 levels correlate with the activities of complexes I and II/III in mitochondria from parkinsonian and nonparkinsonian subjects. Ann Neurol. 1997 Aug;42(2):261-4. doi: 10.1002/ana.410420221.
• Shults CW, Beal MF, Fontaine D, Nakano K, Haas RH. Absorption, tolerability, and effects on mitochondrial activity of oral coenzyme Q10 in parkinsonian patients. Neurology. 1998 Mar;50(3):793-5. doi: 10.1212/wnl.50.3.793.
• Shults CW, Flint Beal M, Song D, Fontaine D. Pilot trial of high dosages of coenzyme Q10 in patients with Parkinson's disease. Exp Neurol. 2004 Aug;188(2):491-4. doi: 10.1016/j.expneurol.2004.05.003.
• Blatt DH, Pryor WA. High-dosage vitamin E supplementation and all-cause mortality. Ann Intern Med. 2005 Jul 19;143(2):150-1; author reply 156-8. doi: 10.7326/0003-4819-143-2-200507190-00018. No abstract available.
• McDonald SR, Sohal RS, Forster MJ. Concurrent administration of coenzyme Q10 and alpha-tocopherol improves learning in aged mice. Free Radic Biol Med. 2005 Mar 15;38(6):729-36. doi: 10.1016/j.freeradbiomed.2004.11.014.
• Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. doi: 10.7326/0003-4819-142-1-200501040-00110. Epub 2004 Nov 10.
• Parkinson Study Group. Effects of tocopherol and deprenyl on the progression of disability in early Parkinson's disease. N Engl J Med. 1993 Jan 21;328(3):176-83. doi: 10.1056/NEJM199301213280305.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: August 22, 2008
• First Submitted That Met QC Criteria: August 22, 2008
• First Posted (Estimate): August 25, 2008

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: December 24, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Parkinson disease; PD; Coenzyme Q10; CoQ
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Tocotrienols; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: U01NS050324 (U.S. NIH Grant/Contract); U01NS050573 (U.S. NIH Grant/Contract)