Effects of Coenzyme Q10 (CoQ) in Parkinson Disease

NCT00740714 | Terminated Phase 3 Results DMC

• 2 other identifiers: U01NS050324U01NS050573
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 68

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; PD; Coenzyme Q10; CoQ

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (22)

• Change in Modified Schwab & England Independence Scale From Baseline to 16 Months

  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

  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

  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

  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

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

Study Arms (3)

A

EXPERIMENTAL

Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)

Drug: Coenzyme Q10 with vitamin E

B

EXPERIMENTAL

Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)

Drug: Coenzyme Q10 with vitamin E

C

PLACEBO COMPARATOR

Placebo (with vitamin E 1200 IU/day)

Drug: placebo with vitamin E

Interventions

Coenzyme Q10 with vitamin E DRUG

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.

Also known as: Coenzyme Q10, ubiquinone, ubidecarenone

A; B

placebo with vitamin E DRUG

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

C

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of Rochester: collaborator

Study Sites (68)

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

Birmingham, Alabama, 35233, United States

Location

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

Phoenix, Arizona, 85013, United States

Location

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

Scottsdale, Arizona, 85260, United States

Location

Sunhealth Research Institute, 10515 West Santa Fe Drive

Sun City, Arizona, 85351, United States

Location

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

Fountain Valley, California, 92708, United States

Location

University of California Irvine, 100 Irvine Hall

Irvine, California, 92697-4275, United States

Location

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

La Jolla, California, 92093-0948, United States

Location

UCLA Medical Center, 710 Westwood Plaza, A-253

Los Angeles, California, 900095, United States

Location

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

Sacramento, California, 95817, United States

Location

The Parkinson's Institute, 675 ALMANOR AVENUE

Sunnyvale, California, 94085, United States

Location

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

Aurora, Colorado, 80045, United States

Location

Colorado Neurological Institute, 701 East Hampden Avenue, Suite 510

Littleton, Colorado, 80113, United States

Location

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

New Haven, Connecticut, 06510, United States

Location

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

Gainsville, Florida, 32610-5806, United States

Location

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

Miami, Florida, 33136, United States

Location

University of South Florida, 4 Columbia Drive, Suite 410

Tampa, Florida, 33606, United States

Location

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

Atlanta, Georgia, 30329, United States

Location

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

Augusta, Georgia, 30912, United States

Location

Northwestern University, 710 North Lake Shore Drive

Chicago, Illinois, 60611, United States

Location

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

Chicago, Illinois, 60612, United States

Location

University of Chicago, 5841 South Maryland Avenue, Mc2030

Chicago, Illinois, 60637, United States

Location

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

Indianapolis, Indiana, 46202, United States

Location

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

Iowa City, Iowa, 52242, United States

Location

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

Kansas City, Kansas, 66160, United States

Location

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

Louisville, Kentucky, 40202, United States

Location

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

New Orleans, Louisiana, 70121, United States

Location

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

Shreveport, Louisiana, 71103, United States

Location

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

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins, 601 North Caroline Street, Suite 5064

Baltimore, Maryland, 21287-0875, United States

Location

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

Elkridge, Maryland, 21075, United States

Location

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

Boston, Massachusetts, 02118, United States

Location

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

Boston, Massachusetts, 02215, United States

Location

University of Minnesota, 420 Delaware Street SE, Mmc 295

Minneapolis, Minnesota, 55455, United States

Location

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

St Louis, Missouri, 63110-1093, United States

Location

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

Albany, New York, 12208, United States

Location

Suny Downstate Medical Center , 450 Clarkson Avenue , Box 1213

Brooklyn, New York, 11203, United States

Location

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

Manhasset, New York, 11030, United States

Location

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

New York, New York, 10003, United States

Location

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

New York, New York, 10003, United States

Location

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

New York, New York, 10021, United States

Location

Weill Medical College of Cornell

New York, New York, 10021, United States

Location

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

New York, New York, 10032, United States

Location

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

Rochester, New York, 14618, United States

Location

JACOBI MEDICAL CENTER, 1400 Pelham Pkwy S

The Bronx, New York, 10461, United States

Location

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

Durham, North Carolina, 27705, United States

Location

University Neurology Inc., 222 Piedmont Avenue, Suite 3200

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic Foundation, 9500 Euclid Avenue S-31

Cleveland, Ohio, 44195, United States

Location

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

Columbus, Ohio, 43210, United States

Location

University of Toledo , 3000 Arlington Avenue , Mail Stop 1195

Toledo, Ohio, 43614, United States

Location

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

Portland, Oregon, 97239-3098, United States

Location

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

Hershey, Pennsylvania, 17033, United States

Location

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

Philadelphia, Pennsylvania, 19107, United States

Location

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

Warwick, Rhode Island, 02886, United States

Location

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

Charleston, South Carolina, 29401, United States

Location

Semmes Murphey Clinic, 1211 Union Avenue, Suite 200

Memphis, Tennessee, 38104, United States

Location

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

Houston, Texas, 77030, United States

Location

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

Burlington, Vermont, 05405, United States

Location

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

Kirkland, Washington, 98034, United States

Location

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

Milwaukee, Wisconsin, 53226-0099, United States

Location

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

Calgary, Alberta, T2N4NI, Canada

Location

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

Edmonton, Alberta, T5G 0B7, Canada

Location

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

London, Ontario, N6A 5A5, Canada

Location

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

Ottawa, Ontario, K1Y 4E9, Canada

Location

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

Toronto, Ontario, M5T 2S8, Canada

Location

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

Montreal, Quebec, H2L 4M1, Canada

Location

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

Québec, Quebec, G1R 3X5, Canada

Location

University of Sherbrooke, 3001 12E Avenue Nord

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Royal University Hospital, 103 Hospital Drive, Room 1663

Saskatoon, Saskatchewan, S7N OW8, Canada

Location

Related Publications (18)

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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.

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

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 24664227 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

coenzyme Q10; Vitamin E; Ubiquinone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Limitations and Caveats

The planned interim analysis for futility based on the first 300 subjects has reached the pre-specified termination criterion.

Results Point of Contact

• Title: M. Flint Beal, MD
• Organization: Weill Medical College of Cornell University

fbeal@med.cornell.edu

212-746-6575

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 25, 2008
• Study Start: December 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 31, 2013
• Results First Posted: January 31, 2013

Record last verified: 2012-12

Locations

US (59); CA (9)