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

• ClinicalTrials.gov Identifier: NCT00740714
• Recruitment Status: Terminated
• First Posted: August 25, 2008
• Results First Posted: January 31, 2013
• Last Update Posted: January 31, 2013
• 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

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Drug: Coenzyme Q10 with vitamin E; Drug: placebo with vitamin E	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Coenzyme Q10 in Parkinson Disease - Phase III
• Study Start Date: December 2008
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

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 Name: 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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.

Secondary Outcome Measures :

1. 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 ]
   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).
2. 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 ]
   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.
3. 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 ]
   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.
4. 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 ]
   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).
5. 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 ]
   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).
6. 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 ]
   Based on samples analyzed to date
7. Adverse Experiences: Back Pain [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
   Number of participants with back pain
8. Adverse Experiences: Constipation [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
   Number of participants with constipation
9. Adverse Experiences: Insomnia [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
   Number of participants with insomnia
10. Adverse Experiences: Anxiety [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with anxiety
11. Adverse Experiences: Tremor [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with tremor
12. Adverse Experiences: Nasopharyngitis [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with nasopharyngitis
13. Adverse Experiences: Diarrhoea [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with diarrhoea
14. Adverse Experiences: Headache [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with headache
15. Adverse Experiences: Urinary Tract Infection [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of patients with urinary tract infections
16. Adverse Experiences: Nausea [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with nausea
17. Adverse Experiences: Hypertension [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with hypertension
18. Adverse Experiences: Depression [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with depression
19. Adverse Experiences: Constipation: Moderate/Severe [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with moderate/severe constipation
20. Adverse Experiences: Anxiety: Moderate/Severe [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with moderate/severe anxiety
21. Adverse Experiences: Back Pain: Moderate/Severe [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with moderate/severe back pain
22. Adverse Experiences: Insomnia: Moderate/Severe [ Time Frame: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits) ]
    Number of participants with moderate/severe insomnia

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South

Birmingham, Alabama, United States, 35233

United States, Arizona

Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720

Phoenix, Arizona, United States, 85013

Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B

Scottsdale, Arizona, United States, 85260

Sunhealth Research Institute, 10515 West Santa Fe Drive

Sun City, Arizona, United States, 85351

United States, California

The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204

Fountain Valley, California, United States, 92708

University of California Irvine, 100 Irvine Hall

Irvine, California, United States, 92697-4275

University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive

La Jolla, California, United States, 92093-0948

UCLA Medical Center, 710 Westwood Plaza, A-253

Los Angeles, California, United States, 900095

UC Davis Dept of Neurology, 4860 Y Street, Suite 3700

Sacramento, California, United States, 95817

The Parkinson's Institute, 675 ALMANOR AVENUE

Sunnyvale, California, United States, 94085

United States, Colorado

Department of Neurology/Mail Stop B185, 12631 East 17Th Avenue Room 5209, Academic Office 1 Po Box 6511

Aurora, Colorado, United States, 80045

Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510

Littleton, Colorado, United States, 80113

United States, Connecticut

The Institute For Neurodegenerative Disorders, 60 Temple Street, Suite 8B

New Haven, Connecticut, United States, 06510

United States, Florida

University of Florida, McKnight Brain Institute Po Box 100236, 100 S Newell Drive L3-100

Gainsville, Florida, United States, 32610-5806

University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5

Miami, Florida, United States, 33136

University of South Florida, 4 Columbia Drive, Suite 410

Tampa, Florida, United States, 33606

United States, Georgia

Emory University School of Medicine, Wesley Woods Health Center, 1841 Clifton Road NE Room 328

Atlanta, Georgia, United States, 30329

Movement Disorders Program, Department of Neurology, Medical College of Georgia

Augusta, Georgia, United States, 30912

United States, Illinois

Northwestern University, 710 North Lake Shore Drive

Chicago, Illinois, United States, 60611

Rush University Medical Center Department of Neurological Sciences, 1725 West Harrison Suite 755

Chicago, Illinois, United States, 60612

University of Chicago, 5841 South Maryland Avenue, Mc2030

Chicago, Illinois, United States, 60637

United States, Indiana

Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150

Indianapolis, Indiana, United States, 46202

United States, Iowa

University of Iowa Hospitals, 2133 Rcp Department of Neurology, 200 Hawkins Drive

Iowa City, Iowa, United States, 52242

United States, Kansas

The University of Kansas Medical Center, Department of Neurology Ms #2012, 3599 Rainbow Boulevard

Kansas City, Kansas, United States, 66160

United States, Kentucky

University of Louisville, Movement Disorder Clinic, Frazier Rehab, 220 Abraham Flexner, Suite 606

Louisville, Kentucky, United States, 40202

United States, Louisiana

Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept of Neurology 7Th Floor

New Orleans, Louisiana, United States, 70121

Lsuhsc Shreveport, Department of Neurology, 1501 Kings Highway Room 3-436

Shreveport, Louisiana, United States, 71103

United States, Maryland

University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B

Baltimore, Maryland, United States, 21201

Johns Hopkins, 601 North Caroline Street, Suite 5064

Baltimore, Maryland, United States, 21287-0875

Parkinson & Movement Dis Center If Maryland, 8180 Lark Brown Road, Suite 101

Elkridge, Maryland, United States, 21075

United States, Massachusetts

Boston University Medical Center, Department of Neurology, 715 Albany Street C329

Boston, Massachusetts, United States, 02118

Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Shapiro 809D

Boston, Massachusetts, United States, 02215

United States, Minnesota

University of Minnesota, 420 Delaware Street SE, Mmc 295

Minneapolis, Minnesota, United States, 55455

United States, Missouri

Washington University School of Medicine, 660 South Euclid, Box 8111

St Louis, Missouri, United States, 63110-1093

United States, New York

Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr, 47 New Scottland Avenue

Albany, New York, United States, 12208

JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S

Bronx, New York, United States, 10461

Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213

Brooklyn, New York, United States, 11203

Northshore-Lij Health System, the Feinstein Institute Fpr Medical Research, 350 Community Drive Room 100

Manhasset, New York, United States, 11030

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, 10003

Parkinson'S Dis & Movement Disorders Inst, 428 East 72Nd Street, Suite 400

New York, New York, United States, 10021

Weill Medical College of Cornell

New York, New York, United States, 10021

Columbia University, 710 West 168Th Street, 3Rd Floor

New York, New York, United States, 10032

University of Rochester Department of Neurology, 919 Westfall Road Building C Suite 220

Rochester, New York, United States, 14618

United States, North Carolina

Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213

Durham, North Carolina, United States, 27705

United States, Ohio

University Neurology Inc., 222 Piedmont Avenue, Suite 3200

Cincinnati, Ohio, United States, 45219

The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31

Cleveland, Ohio, United States, 44195

Ohio State University Medical Center, 1581 Dodd Drive, 371 McCampbell Hall

Columbus, Ohio, United States, 43210

University of Toledo , 3000 Arlington Avenue , Mail Stop 1195

Toledo, Ohio, United States, 43614

United States, Oregon

Oregon Health & Science University, Dept of Neurology, 3181 SW Sam Jackson Park Road Op-32

Portland, Oregon, United States, 97239-3098

United States, Pennsylvania

Penn State Milton S Hershey Med Center, Department of Neurology Mc H109 Room 2846, 500 University Drive Po Box 850

Hershey, Pennsylvania, United States, 17033

University of Pennsylvania, Pennsylvania Hospital Department of Neurology, 330 South 9Th Street

Philadelphia, Pennsylvania, United States, 19107

United States, Rhode Island

Neurohealth Parkinson'S Disease, Movement Disorder Center, 227 Centerville Road

Warwick, Rhode Island, United States, 02886

United States, South Carolina

Medical University of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308

Charleston, South Carolina, United States, 29401

United States, Tennessee

Semmes Murphey Clinic, 1211 Union Avenue, Suite 200

Memphis, Tennessee, United States, 38104

United States, Texas

Baylor College of Medicine - Parkinson'S, Disease Center and Movement Disorders Clinic, 65501 Fannin St, Suite 1801

Houston, Texas, United States, 77030

United States, Vermont

University of Vermont , Department of Neurology Given Building C-219 , 89 Beaumont Avenue

Burlington, Vermont, United States, 05405

United States, Washington

Booth Gardner Parkinson'S Care Center, 13030 121St Way North East Suite 203

Kirkland, Washington, United States, 98034

United States, Wisconsin

Medical College of Wisconsin, Department of Neurology, 9200 West Wisconsin Avenue

Milwaukee, Wisconsin, United States, 53226-0099

Canada, Alberta

Un of Calgary Movement Disorders Program, Dept of Clin Neurosciences Area 3 Neurology, 3350 Hospital Dr NW Health Sciences Centre

Calgary, Alberta, Canada, T2N4NI

University of Alberta Glenrose Rehab Hosp, Rm 0601 Glen East, 10230 - 111 Avenue

Edmonton, Alberta, Canada, T5G 0B7

Canada, Ontario

London Health Sciences Centre, University Campus Room 10N29, 339 Windermere Road

London, Ontario, Canada, N6A 5A5

The Ottawa Hospital-Civic Campus, 1053 Carling Avenue C2 Room 2210

Ottawa, Ontario, Canada, K1Y 4E9

Toronto Western Hospital, Univ Health Network, 399 Bathurst Street Mc 7-402, Movement Disorders Centre

Toronto, Ontario, Canada, M5T 2S8

Canada, Quebec

CHUM-HOPITAL NOTRE DAME, 1560 rue SHERBROOKE est ROOM GR 1185, PAVILLON DECHAMPS etage rez-de-chaussee

Montreal, Quebec, Canada, H2L 4M1

University of Sherbrooke, 3001 12E Avenue Nord

Sherbrooke, Quebec, Canada, J1H 5N4

Canada, Saskatchewan

Royal University Hospital, 103 Hospital Drive, Room 1663

Saskatoon, Saskatchewan, Canada, S7N OW8

Canada

Quebec Memory and Motor Skills Dis Clinic, Price Building 3Rd Floor, 65 Sainte-Anne Street

Quebec, Canada, G1R 3X5

Sponsors and Collaborators

Weill Medical College of Cornell University

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

More Information

Publications:

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.

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.

Beal MF. Coenzyme Q10 as a possible treatment for neurodegenerative diseases. Free Radic Res. 2002 Apr;36(4):455-60. doi: 10.1080/10715760290021315.

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, 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.

Shults CW. Coenzyme Q10 in neurodegenerative diseases. Curr Med Chem. 2003 Oct;10(19):1917-21. doi: 10.2174/0929867033456882.

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.

Lee IM, Cook NR, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE. Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial. JAMA. 2005 Jul 6;294(1):56-65. doi: 10.1001/jama.294.1.56.

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.

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
• Other Study ID Numbers: U01NS050324 ( U.S. NIH Grant/Contract ); U01NS050573 ( U.S. NIH Grant/Contract )
• First Posted: August 25, 2008
• Results First Posted: January 31, 2013
• Last Update Posted: January 31, 2013
• Last Verified: December 2012

Keywords provided by Weill Medical College of Cornell University:

Parkinson disease; PD; Coenzyme Q10; CoQ

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Coenzyme Q10; Ubiquinone; Micronutrients; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents