Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
600 participants
INTERVENTIONAL
2008-12-31
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
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.
B
Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
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.
C
Placebo (with vitamin E 1200 IU/day)
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Rochester
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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M. Flint Beal, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University, New York Hospital Department of Neurology
David Oakes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester, Department of Biostatistics
Ira Shoulson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester, Clinical Trials Coordination Center
Locations
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University of Alabama, Birmingham, 350 Sparks Center, 1720 7Th Avenue South
Birmingham, Alabama, United States
Barrow Neurological Clinics At St Joseph'S Hospital & Medical Center, 500 West Thomas Road Suite 720
Phoenix, Arizona, United States
Mayo Clinic Arizona, 13400 East Shea Boulevard, Desk 34 3B
Scottsdale, Arizona, United States
Sunhealth Research Institute, 10515 West Santa Fe Drive
Sun City, Arizona, United States
The Parkinson'S & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204
Fountain Valley, California, United States
University of California Irvine, 100 Irvine Hall
Irvine, California, United States
University of California San Diego, Alzheimer'S Disease Research Center, 9500 Gilman Drive
La Jolla, California, United States
UCLA Medical Center, 710 Westwood Plaza, A-253
Los Angeles, California, United States
UC Davis Dept of Neurology, 4860 Y Street, Suite 3700
Sacramento, California, United States
The Parkinson's Institute, 675 ALMANOR AVENUE
Sunnyvale, California, United States
Department of Neurology/Mail Stop B185, 12631 East 17Th Avenue Room 5209, Academic Office 1 Po Box 6511
Aurora, Colorado, United States
Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510
Littleton, Colorado, United States
The Institute For Neurodegenerative Disorders, 60 Temple Street, Suite 8B
New Haven, Connecticut, United States
University of Florida, McKnight Brain Institute Po Box 100236, 100 S Newell Drive L3-100
Gainsville, Florida, United States
University of Miami, 1501 North West 9Th Avenue Second Floor, Department of Neurology D4-5
Miami, Florida, United States
University of South Florida, 4 Columbia Drive, Suite 410
Tampa, Florida, United States
Emory University School of Medicine, Wesley Woods Health Center, 1841 Clifton Road NE Room 328
Atlanta, Georgia, United States
Movement Disorders Program, Department of Neurology, Medical College of Georgia
Augusta, Georgia, United States
Northwestern University, 710 North Lake Shore Drive
Chicago, Illinois, United States
Rush University Medical Center Department of Neurological Sciences, 1725 West Harrison Suite 755
Chicago, Illinois, United States
University of Chicago, 5841 South Maryland Avenue, Mc2030
Chicago, Illinois, United States
Indiana University School of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150
Indianapolis, Indiana, United States
University of Iowa Hospitals, 2133 Rcp Department of Neurology, 200 Hawkins Drive
Iowa City, Iowa, United States
The University of Kansas Medical Center, Department of Neurology Ms #2012, 3599 Rainbow Boulevard
Kansas City, Kansas, United States
University of Louisville, Movement Disorder Clinic, Frazier Rehab, 220 Abraham Flexner, Suite 606
Louisville, Kentucky, United States
Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept of Neurology 7Th Floor
New Orleans, Louisiana, United States
Lsuhsc Shreveport, Department of Neurology, 1501 Kings Highway Room 3-436
Shreveport, Louisiana, United States
University of Maryland School of Medicine, 22 South Greene Street, N4 W49-B
Baltimore, Maryland, United States
Johns Hopkins, 601 North Caroline Street, Suite 5064
Baltimore, Maryland, United States
Parkinson & Movement Dis Center If Maryland, 8180 Lark Brown Road, Suite 101
Elkridge, Maryland, United States
Boston University Medical Center, Department of Neurology, 715 Albany Street C329
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Shapiro 809D
Boston, Massachusetts, United States
University of Minnesota, 420 Delaware Street SE, Mmc 295
Minneapolis, Minnesota, United States
Washington University School of Medicine, 660 South Euclid, Box 8111
St Louis, Missouri, United States
Albany Medical College, Parkinson'S Disease & Movement Disorders Ctr, 47 New Scottland Avenue
Albany, New York, United States
Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213
Brooklyn, New York, United States
Northshore-Lij Health System, the Feinstein Institute Fpr Medical Research, 350 Community Drive Room 100
Manhasset, New York, United States
Beth Israel Medical Center, 10 Union Square East, Suite 5Hh2
New York, New York, United States
Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Room 5Ho1
New York, New York, United States
Parkinson'S Dis & Movement Disorders Inst, 428 East 72Nd Street, Suite 400
New York, New York, United States
Weill Medical College of Cornell
New York, New York, United States
Columbia University, 710 West 168Th Street, 3Rd Floor
New York, New York, United States
University of Rochester Department of Neurology, 919 Westfall Road Building C Suite 220
Rochester, New York, United States
JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S
The Bronx, New York, United States
Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213
Durham, North Carolina, United States
University Neurology Inc., 222 Piedmont Avenue, Suite 3200
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31
Cleveland, Ohio, United States
Ohio State University Medical Center, 1581 Dodd Drive, 371 McCampbell Hall
Columbus, Ohio, United States
University of Toledo , 3000 Arlington Avenue , Mail Stop 1195
Toledo, Ohio, United States
Oregon Health & Science University, Dept of Neurology, 3181 SW Sam Jackson Park Road Op-32
Portland, Oregon, United States
Penn State Milton S Hershey Med Center, Department of Neurology Mc H109 Room 2846, 500 University Drive Po Box 850
Hershey, Pennsylvania, United States
University of Pennsylvania, Pennsylvania Hospital Department of Neurology, 330 South 9Th Street
Philadelphia, Pennsylvania, United States
Neurohealth Parkinson'S Disease, Movement Disorder Center, 227 Centerville Road
Warwick, Rhode Island, United States
Medical University of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308
Charleston, South Carolina, United States
Semmes Murphey Clinic, 1211 Union Avenue, Suite 200
Memphis, Tennessee, United States
Baylor College of Medicine - Parkinson'S, Disease Center and Movement Disorders Clinic, 65501 Fannin St, Suite 1801
Houston, Texas, United States
University of Vermont , Department of Neurology Given Building C-219 , 89 Beaumont Avenue
Burlington, Vermont, United States
Booth Gardner Parkinson'S Care Center, 13030 121St Way North East Suite 203
Kirkland, Washington, United States
Medical College of Wisconsin, Department of Neurology, 9200 West Wisconsin Avenue
Milwaukee, Wisconsin, United States
Un of Calgary Movement Disorders Program, Dept of Clin Neurosciences Area 3 Neurology, 3350 Hospital Dr NW Health Sciences Centre
Calgary, Alberta, Canada
University of Alberta Glenrose Rehab Hosp, Rm 0601 Glen East, 10230 - 111 Avenue
Edmonton, Alberta, Canada
London Health Sciences Centre, University Campus Room 10N29, 339 Windermere Road
London, Ontario, Canada
The Ottawa Hospital-Civic Campus, 1053 Carling Avenue C2 Room 2210
Ottawa, Ontario, Canada
Toronto Western Hospital, Univ Health Network, 399 Bathurst Street Mc 7-402, Movement Disorders Centre
Toronto, Ontario, Canada
CHUM-HOPITAL NOTRE DAME, 1560 rue SHERBROOKE est ROOM GR 1185, PAVILLON DECHAMPS etage rez-de-chaussee
Montreal, Quebec, Canada
Quebec Memory and Motor Skills Dis Clinic, Price Building 3Rd Floor, 65 Sainte-Anne Street
Québec, Quebec, Canada
University of Sherbrooke, 3001 12E Avenue Nord
Sherbrooke, Quebec, Canada
Royal University Hospital, 103 Hospital Drive, Room 1663
Saskatoon, Saskatchewan, Canada
Countries
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References
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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.
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.
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.
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