AzTrials
AzTrials

Parkinson DiseasePhase 3QE3NCT00740714

Effects of Coenzyme Q10 (CoQ) in Parkinson Disease

A Phase 3 study testing Coenzyme Q10 with vitamin E in people with Parkinson Disease, run by Weill Medical College of Cornell University at 68 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Coenzyme Q10 with vitamin E
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
68 sitesin 2 countries
Study dates
Dec 2008to Aug 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

68 sites in 2 countries.

68 sites in 2 countries

United States59 sites

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

    Albany, New York, 12208

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

    Atlanta, Georgia, 30329

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

    Augusta, Georgia, 30912

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

    Aurora, Colorado, 80045

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

    Baltimore, Maryland, 21201

  • Johns Hopkins, 601 North Caroline Street, Suite 5064

    Baltimore, Maryland, 21287-0875

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

    Birmingham, Alabama, 35233

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

    Boston, Massachusetts, 02118

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

    Boston, Massachusetts, 02215

  • Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213

    Brooklyn, New York, 11203

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

    Burlington, Vermont, 05405

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

    Charleston, South Carolina, 29401

  • Northwestern University, 710 North Lake Shore Drive

    Chicago, Illinois, 60611

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

    Chicago, Illinois, 60612

  • University of Chicago, 5841 South Maryland Avenue, Mc2030

    Chicago, Illinois, 60637

  • University Neurology Inc., 222 Piedmont Avenue, Suite 3200

    Cincinnati, Ohio, 45219

  • The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31

    Cleveland, Ohio, 44195

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

    Columbus, Ohio, 43210

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

    Durham, North Carolina, 27705

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

    Elkridge, Maryland, 21075

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

    Fountain Valley, California, 92708

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

    Gainsville, Florida, 32610-5806

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

    Hershey, Pennsylvania, 17033

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

    Houston, Texas, 77030

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

    Indianapolis, Indiana, 46202

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

    Iowa City, Iowa, 52242

  • University of California Irvine, 100 Irvine Hall

    Irvine, California, 92697-4275

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

    Kansas City, Kansas, 66160

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

    Kirkland, Washington, 98034

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

    La Jolla, California, 92093-0948

  • Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510

    Littleton, Colorado, 80113

  • UCLA Medical Center, 710 Westwood Plaza, A-253

    Los Angeles, California, 900095

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

    Louisville, Kentucky, 40202

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

    Manhasset, New York, 11030

  • Semmes Murphey Clinic, 1211 Union Avenue, Suite 200

    Memphis, Tennessee, 38104

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

    Miami, Florida, 33136

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

    Milwaukee, Wisconsin, 53226-0099

  • University of Minnesota, 420 Delaware Street SE, Mmc 295

    Minneapolis, Minnesota, 55455

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

    New Haven, Connecticut, 06510

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

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center, 10 Union Square East, Suite 5Hh2

    New York, New York, 10003

  • Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Room 5Ho1

    New York, New York, 10003

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

    New York, New York, 10021

  • Weill Medical College of Cornell

    New York, New York, 10021

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

    New York, New York, 10032

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

    Philadelphia, Pennsylvania, 19107

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

    Phoenix, Arizona, 85013

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

    Portland, Oregon, 97239-3098

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

    Rochester, New York, 14618

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

    Sacramento, California, 95817

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

    Scottsdale, Arizona, 85260

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

    Shreveport, Louisiana, 71103

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

    St Louis, Missouri, 63110-1093

  • Sunhealth Research Institute, 10515 West Santa Fe Drive

    Sun City, Arizona, 85351

  • The Parkinson's Institute, 675 ALMANOR AVENUE

    Sunnyvale, California, 94085

  • University of South Florida, 4 Columbia Drive, Suite 410

    Tampa, Florida, 33606

  • JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S

    The Bronx, New York, 10461

  • University of Toledo , 3000 Arlington Avenue , Mail Stop 1195

    Toledo, Ohio, 43614

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

    Warwick, Rhode Island, 02886

Other trials in United States

Canada9 sites

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

    Calgary, Alberta, T2N4NI

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

    Edmonton, Alberta, T5G 0B7

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

    London, Ontario, N6A 5A5

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

    Montreal, Quebec, H2L 4M1

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

    Ottawa, Ontario, K1Y 4E9

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

    Québec, Quebec, G1R 3X5

  • Royal University Hospital, 103 Hospital Drive, Room 1663

    Saskatoon, Saskatchewan, S7N OW8

  • University of Sherbrooke, 3001 12E Avenue Nord

    Sherbrooke, Quebec, J1H 5N4

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

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Coenzyme Q10 with vitamin E, placebo with vitamin E
Keywords
Parkinson disease, PD, Coenzyme Q10, CoQ
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coenzyme Q10 with vitamin EDrug

    Also called Coenzyme Q10, ubiquinone, ubidecarenone

    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.

  • placebo with vitamin EDrug

    placebo or an inactive substance (with vitamin E 1200 IU/day); Placebo - eight chewable wafers taken orally four times a day.

Study groups in NCT00740714
Study groupRoleWhat they receive
AExperimentalRandomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
Receives: Drug: Coenzyme Q10 with vitamin E
BExperimentalRandomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
Receives: Drug: Coenzyme Q10 with vitamin E
CPlacebo comparatorPlacebo (with vitamin E 1200 IU/day)
Receives: Drug: placebo with vitamin E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

Secondary outcomes (22)

  1. 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).

    Measured: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

  2. 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.

    Measured: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

  3. 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.

    Measured: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

  4. 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).

    Measured: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

  5. 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).

    Measured: Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

  6. CoQ10 Levels in Plasma

    Based on samples analyzed to date

    Measured: Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first

  7. Adverse Experiences: Back Pain

    Number of participants with back pain

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  8. Adverse Experiences: Constipation

    Number of participants with constipation

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  9. Adverse Experiences: Insomnia

    Number of participants with insomnia

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  10. Adverse Experiences: Anxiety

    Number of participants with anxiety

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  11. Adverse Experiences: Tremor

    Number of participants with tremor

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  12. Adverse Experiences: Nasopharyngitis

    Number of participants with nasopharyngitis

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  13. Adverse Experiences: Diarrhoea

    Number of participants with diarrhoea

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  14. Adverse Experiences: Headache

    Number of participants with headache

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  15. Adverse Experiences: Urinary Tract Infection

    Number of patients with urinary tract infections

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  16. Adverse Experiences: Nausea

    Number of participants with nausea

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  17. Adverse Experiences: Hypertension

    Number of participants with hypertension

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  18. Adverse Experiences: Depression

    Number of participants with depression

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  19. Adverse Experiences: Constipation: Moderate/Severe

    Number of participants with moderate/severe constipation

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  20. Adverse Experiences: Anxiety: Moderate/Severe

    Number of participants with moderate/severe anxiety

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  21. Adverse Experiences: Back Pain: Moderate/Severe

    Number of participants with moderate/severe back pain

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

  22. Adverse Experiences: Insomnia: Moderate/Severe

    Number of participants with moderate/severe insomnia

    Measured: Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionAug 2011
  4. Study completionAug 2011

Why it stopped: The investigational drug is unlikely to demonstrate efficacy over placebo for this indication. However, no safety issues were discovered.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00740714
Sponsor's protocol ID
U01NS050324
Other IDs
U01NS050573
Acronym
QE3
Status last verified
Dec 2012
First submitted
22 Aug 2008
Last updated
31 Jan 2013
Data monitoring committee
Yes

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.

    PubMed 7998775

  • 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.

    PubMed 9479058

  • 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.

    PubMed 10856939

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

    PubMed 12069110

  • 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.

    PubMed 17200487

  • 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.

    PubMed 12707423

  • 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.

    PubMed 12112107

  • 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.

    PubMed 9266740

  • 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.

    PubMed 9521279

  • 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.

    PubMed 12374491

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

    PubMed 12871093

  • 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.

    PubMed 15246848

  • 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.

    PubMed 15998891

  • 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.

    PubMed 16027460

  • 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.

    PubMed 15721983

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Coenzyme Q10 with vitamin E in people with Parkinson Disease, run by Weill Medical College of Cornell University at 68 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00740714, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in