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A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit.

Abstract

IMPORTANCE

Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson disease (PD) models to reduce the loss of dopamine neurons, and was safe and well tolerated in early-phase human studies. A previous phase II study suggested possible clinical benefit.

OBJECTIVE

To examine whether CoQ10 could slow disease progression in early PD.

DESIGN, SETTING, AND PARTICIPANTS

A phase III randomized, placebo-controlled, double-blind clinical trial at 67 North American sites consisting of participants 30 years of age or older who received a diagnosis of PD within 5 years and who had the following inclusion criteria: the presence of a rest tremor, bradykinesia, and rigidity; a modified Hoehn and Yahr stage of 2.5 or less; and no anticipated need for dopaminergic therapy within 3 months. Exclusion criteria included the use of any PD medication within 60 days, the use of any symptomatic PD medication for more than 90 days, atypical or drug-induced parkinsonism, a Unified Parkinson's Disease Rating Scale (UPDRS) rest tremor score of 3 or greater for any limb, a Mini-Mental State Examination score of 25 or less, a history of stroke, the use of certain supplements, and substantial recent exposure to CoQ10. Of 696 participants screened, 78 were found to be ineligible, and 18 declined participation.

INTERVENTIONS

The remaining 600 participants were randomly assigned to receive placebo, 1200 mg/d of CoQ10, or 2400 mg/d of CoQ10; all participants received 1200 IU/d of vitamin E.

MAIN OUTCOMES AND MEASURES

Participants were observed for 16 months or until a disability requiring dopaminergic treatment. The prospectively defined primary outcome measure was the change in total UPDRS score (Parts I-III) from baseline to final visit. The study was powered to detect a 3-point difference between an active treatment and placebo.

RESULTS

The baseline characteristics of the participants were well balanced, the mean age was 62.5 years, 66% of participants were male, and the mean baseline total UPDRS score was 22.7. A total of 267 participants required treatment (94 received placebo, 87 received 1200 mg/d of CoQ10, and 86 received 2400 mg/d of CoQ10), and 65 participants (29 who received placebo, 19 who received 1200 mg/d of CoQ10, and 17 who received 2400 mg/d of CoQ10) withdrew prematurely. Treatments were well tolerated with no safety concerns. The study was terminated after a prespecified futility criterion was reached. At study termination, both active treatment groups showed slight adverse trends relative to placebo. Adjusted mean changes (worsening) in total UPDRS scores from baseline to final visit were 6.9 points (placebo), 7.5 points (1200 mg/d of CoQ10; P = .49 relative to placebo), and 8.0 points (2400 mg/d of CoQ10; P = .21 relative to placebo).

CONCLUSIONS AND RELEVANCE

Coenzyme Q10 was safe and well tolerated in this population, but showed no evidence of clinical benefit.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00740714.

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  • Authors+Show Affiliations

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    Department of Neurology, Weill Cornell Medical College, New York Hospital, New York.

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    Department of Biostatistics, University of Rochester Medical Center, Rochester, New York.

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    Department of Neurology, Georgetown University, Washington, DC.

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    Department of Neurology, Weill Cornell Medical College, New York Hospital, New York.

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    National Institutes of Health, Bethesda, Maryland.

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    Department of Neurosciences, University of California, San Diego, La Jolla.

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    Department of Neurology, Emory University School of Medicine, Wesley Woods Center, Atlanta, Georgia.

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    Department of Neurology, Oregon Health and Science University, Portland.

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    Merck, New Jersey.

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    Biogen Idec, Cambridge, Massachusetts.

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    Department of Neurosciences, University of California, San Diego, La Jolla10VA Medical Center, San Diego, California.

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    Department of Biostatistics, University of Rochester Medical Center, Rochester, New York.

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    Department of Biostatistics, University of Rochester Medical Center, Rochester, New York.

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    Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles.

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    Department of Biostatistics, University of Rochester Medical Center, Rochester, New York.

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    Department of Biostatistics, University of Rochester Medical Center, Rochester, New York12Department of Neurology, University of Rochester, Rochester, New York.

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    Department of Biostatistics, University of Rochester Medical Center, Rochester, New York.

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    Québec Memory and Motor Skills Disorders Research Center, Clinique Sainte-Anne, Québec, Canada.

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    Québec Memory and Motor Skills Disorders Research Center, Clinique Sainte-Anne, Québec, Canada.

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    Rush University Medical Center, Chicago, Illinois.

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    Booth Gardner Parkinson's Care Center, EvergreenHealth, Kirkland, Washington.

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    Booth Gardner Parkinson's Care Center, EvergreenHealth, Kirkland, Washington.

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    London Health Sciences Centre, London, Ontario, Canada.

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    London Health Sciences Centre, London, Ontario, Canada.

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    London Health Sciences Centre, London, Ontario, Canada.

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    Overlook Medical Center, Atlantic Neuroscience Institute, Summit, New Jersey.

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    Department of Neurology, University of Rochester, Rochester, New York.

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    Department of Neurology, University of Rochester, Rochester, New York.

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    Columbia University Medical Center, Neurological Institute, New York, New York.

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    Columbia University Medical Center, Neurological Institute, New York, New York.

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    Department of Neurology, Weill Cornell Medical College, New York Hospital, New York.

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    Department of Neurology, Oregon Health and Science University, Portland.

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    Department of Neurology, University of Texas Health Science Center at Houston.

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    Department of Neurology, Baylor College of Medicine, Houston, Texas.

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    Department of Neurology, Baylor College of Medicine, Houston, Texas.

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    Department of Neurology, Baylor College of Medicine, Houston, Texas.

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    Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.

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    Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.

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    The Parkinson's Institute and Clinical Center, Sunnyvale, California.

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    The Parkinson's Institute and Clinical Center, Sunnyvale, California.

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    The Parkinson's Institute and Clinical Center, Sunnyvale, California.

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    Department of Neurology, University of Miami School of Medicine, Miami, Florida.

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    Department of Neurology, University of Miami School of Medicine, Miami, Florida.

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    Institute for Neurodegenerative Disorders, New Haven, Connecticut.

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    Institute for Neurodegenerative Disorders, New Haven, Connecticut.

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    Department of Neurology, Butler Hospital, Providence, Rhode Island26Alpert Medical School, Brown University, Providence, Rhode Island.

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    Department of Neurology, Butler Hospital, Providence, Rhode Island27Port City Neurology, Inc, Scarborough, Maine.

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    Department of Neurology, University of California, Davis, School of Medicine and Sacramento VA Medical Center, Sacramento.

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    Port City Neurology, Inc, Scarborough, Maine.

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    Colorado Neurological Institute, Englewood.

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    Milton S. Hershey Medical Center, Department of Neurology, Pennsylvania State Hershey College of Medicine, Hershey.

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    Milton S. Hershey Medical Center, Department of Neurology, Pennsylvania State Hershey College of Medicine, Hershey.

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    Ottawa Hospital Civic Site, Ottawa, Ontario, Canada.

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    Ottawa Hospital Civic Site, Ottawa, Ontario, Canada.

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    Ottawa Hospital Civic Site, Ottawa, Ontario, Canada.

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    Avid Radiopharmaceuticals, Philadelphia, Pennsylvania.

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    Department of Neurology, Emory University School of Medicine, Wesley Woods Center, Atlanta, Georgia33Atlanta VA Medical Center, Atlanta, Georgia.

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    Department of Neurology, Emory University School of Medicine, Wesley Woods Center, Atlanta, Georgia.

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    Muhammad Ali Parkinson Center, Barrow Neurological Institute, St Joseph's Hospital and Medical Center, Phoenix, Arizona.

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    Department of Neurology, University of Florida Center for Movement Disorders and Neurorestoration, Gainesville.

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    Department of Neurology, University of Florida Center for Movement Disorders and Neurorestoration, Gainesville.

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    Department of Neurology, University of Florida Center for Movement Disorders and Neurorestoration, Gainesville.

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    Department of Neurology, University of Florida Center for Movement Disorders and Neurorestoration, Gainesville.

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    Glenrose Rehabilitation Hospital, University of Alberta, Edmonton, Alberta, Canada.

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    Glenrose Rehabilitation Hospital, University of Alberta, Edmonton, Alberta, Canada.

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    Department of Neurology, University of Alabama at Birmingham.

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    Department of Neurology, University of Alabama at Birmingham.

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    Department of Neurology, University of Alabama at Birmingham.

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    Center for Neurological Restoration, Department of Neurology, Cleveland Clinic, Cleveland, Ohio.

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    Center for Neurological Restoration, Department of Neurology, Cleveland Clinic, Cleveland, Ohio.

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    Center for Neurological Restoration, Department of Neurology, Cleveland Clinic, Cleveland, Ohio.

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    Department of Neurology, Johns Hopkins University, Baltimore, Maryland.

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    Department of Neurology, Johns Hopkins University, Baltimore, Maryland.

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    Department of Neurology, Johns Hopkins University, Baltimore, Maryland.

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    Feinstein Institute for Medical Research, Center for Neurosciences, Manhasset, New York.

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    Feinstein Institute for Medical Research, Center for Neurosciences, Manhasset, New York.

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    Department of Neurology, New York University Langone Medical Center, New York.

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    Department of Neurology, Weill Cornell Medical College, New York Hospital, New York.

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    Department of Neurology, Boston University School of Medicine, Boston, Massachusetts.

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    Department of Neurology, Boston University School of Medicine, Boston, Massachusetts.

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    The Parkinson's and Movement Disorder Institute, Fountain Valley, California.

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    State University of New York, Downstate Medical Center, Brooklyn, New York.

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    State University of New York, Downstate Medical Center, Brooklyn, New York.

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    State University of New York, Downstate Medical Center, Brooklyn, New York.

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    Department of Neurology, University of South Florida, Tampa.

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    Department of Neurology, University of Kansas Medical Center, Kansas City.

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    Department of Neurology, University of Kansas Medical Center, Kansas City.

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    Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.

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    Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.

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    Department of Neurology, Georgia Health Science University, Augusta.

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    Department of Neurology, Georgia Health Science University, Augusta.

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    Department of Neurology, Georgia Health Science University, Augusta.

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    Department of Neurosciences, University of California, San Diego, La Jolla.

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    Department of Neurology, University of Louisville, Kentucky.

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    University of Cincinnati College of Medicine, Cincinnati, Ohio.

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    University of Cincinnati College of Medicine, Cincinnati, Ohio.

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    Department of Neurology, Medical University of South Carolina, Charleston.

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    Associated Neurologists, PC, Danbury, Connecticut.

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    Associated Neurologists, PC, Danbury, Connecticut.

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    Department of Neurology, Washington University in St Louis, Missouri.

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    Department of Neurology, Washington University in St Louis, Missouri.

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    Movement Disorders Center, Albany Medical Center, Albany, New York.

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    Movement Disorders Center, Albany Medical Center, Albany, New York.

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    Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic, Scottsdale, Arizona.

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    Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic, Scottsdale, Arizona.

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    Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic, Scottsdale, Arizona.

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    Center for Neurological Health, University of Toledo, Toledo, Ohio.

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    Department of Neurology, Medical University of Ohio at Toledo.

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    Department of Neurology, Medical University of Ohio at Toledo.

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    Department of Neurology, Medical University of Ohio at Toledo.

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    Department of Neurology, University of Colorado Health Science Center, Denver.

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    Department of Neurology, University of California, Irvine Medical Center, Irvine.

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    Department of Neurology, University of California, Irvine Medical Center, Irvine.

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    Banner Sun Health Research Institute, Sun City, Arizona.

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    Banner Sun Health Research Institute, Sun City, Arizona.

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    Department of Neurology, University of Saskatchewan, Royal University Hospital, Saskatchewan, Canada.

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    Department of Neurology, University of Saskatchewan, Royal University Hospital, Saskatchewan, Canada.

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    Department of Neurology, University of California, San Diego, La Jolla.

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    Department of Neurology, University of California, San Diego, La Jolla.

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    Department of Neurology, University of California, San Diego, La Jolla.

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    Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

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    Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

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    Department of Neurology, Medical College of Wisconsin, Milwaukee.

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    Department of Neurology, Medical College of Wisconsin, Milwaukee.

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    Department of Neurology, Medical College of Wisconsin, Milwaukee.

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    Department of Neurology, Duke University, Durham, North Carolina.

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    Department of Neurology, Duke University, Durham, North Carolina.

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    State University of New York Upstate Medical Center and Syracuse VA Medical Center, Syracuse.

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    State University of New York Upstate Medical Center and Syracuse VA Medical Center, Syracuse.

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    Department of Neurology, University of Iowa, Iowa City.

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    Department of Neurology, University of Iowa, Iowa City.

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    Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.

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    Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.

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    Department of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.

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    Department of Neurology, University of Vermont College of Medicine, Burlington.

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    Department of Neurology, University of Vermont College of Medicine, Burlington.

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    Department of Neurology, University of Vermont College of Medicine, Burlington.

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    Department of Neurology, University of Vermont College of Medicine, Burlington.

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    Department of Neurology, Ohio State University, Columbus.

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    Department of Neurology, Ohio State University, Columbus.

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    Department of Neurology, Indiana University School of Medicine, Indianapolis.

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    Department of Neurology, University of Tennessee Health Science Center, Memphis.

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    Department of Neurology, CHUM-Hôpital Notre-Dame, Montréal, Québec, Canada.

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    Department of Neurology, CHUM-Hôpital Notre-Dame, Montréal, Québec, Canada.

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    Department of Neurology, University of Maryland School of Science, Baltimore.

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    Department of Neurology, University of Maryland School of Science, Baltimore.

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    Department of Neurology, University of Maryland School of Science, Baltimore.

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    Department of Neurology, University of Sherbrooke, Québec, Canada.

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    Department of Neurology, Louisiana State University Health Science Center, Shreveport.

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    Department of Neurology, Louisiana State University Health Science Center, Shreveport.

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    Lewis Hall Singletary Oncology Center, Thomasville, Georgia.

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    Department of Neurology, Johns Hopkins University, Baltimore, Maryland.

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    Parkinson and Movement Disorders Center of Maryland, Elkridge.

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    Department of Neurology, University of Minnesota, Minneapolis.

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    Department of Neurology, University of Minnesota, Minneapolis.

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    Department of Neurology, University of Chicago, Chicago, Illinois.

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    Department of Neurology, University of Chicago, Chicago, Illinois.

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    Department of Neurology, Ochsner Clinic Foundation, New Orleans, Louisiana.

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    Department of Neurology, Ochsner Clinic Foundation, New Orleans, Louisiana.

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    Department of Neurology, Beth Israel Medical Center, New York, New York.

    Department of Neurology, Beth Israel Medical Center, New York, New York.

    Source

    JAMA neurology 71:5 2014 May pg 543-52

    MeSH

    Aged
    Antioxidants
    Dose-Response Relationship, Drug
    Double-Blind Method
    Early Diagnosis
    Female
    Humans
    Male
    Middle Aged
    Parkinson Disease
    Prospective Studies
    Treatment Outcome
    Ubiquinone

    Pub Type(s)

    Clinical Trial, Phase III
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    24664227

    Citation

    TY - JOUR T1 - A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit. AU - ,, AU - Beal,M Flint, AU - Oakes,David, AU - Shoulson,Ira, AU - Henchcliffe,Claire, AU - Galpern,Wendy R, AU - Haas,Richard, AU - Juncos,Jorge L, AU - Nutt,John G, AU - Voss,Tiffini Smith, AU - Ravina,Bernard, AU - Shults,Clifford M, AU - Helles,Karen, AU - Snively,Victoria, AU - Lew,Mark F, AU - Griebner,Brian, AU - Watts,Arthur, AU - Gao,Shan, AU - Pourcher,Emmanuelle, AU - Bond,Louisette, AU - Kompoliti,Katie, AU - Agarwal,Pinky, AU - Sia,Cherissa, AU - Jog,Mandar, AU - Cole,Linda, AU - Sultana,Munira, AU - Kurlan,Roger, AU - Richard,Irene, AU - Deeley,Cheryl, AU - Waters,Cheryl H, AU - Figueroa,Angel, AU - Arkun,Ani, AU - Brodsky,Matthew, AU - Ondo,William G, AU - Hunter,Christine B, AU - Jimenez-Shahed,Joohi, AU - Palao,Alicia, AU - Miyasaki,Janis M, AU - So,Julie, AU - Tetrud,James, AU - Reys,Liza, AU - Smith,Katharine, AU - Singer,Carlos, AU - Blenke,Anita, AU - Russell,David S, AU - Cotto,Candace, AU - Friedman,Joseph H, AU - Lannon,Margaret, AU - Zhang,Lin, AU - Drasby,Edward, AU - Kumar,Rajeev, AU - Subramanian,Thyagarajan, AU - Ford,Donna Stuppy, AU - Grimes,David A, AU - Cote,Diane, AU - Conway,Jennifer, AU - Siderowf,Andrew D, AU - Evatt,Marian Leslie, AU - Sommerfeld,Barbara, AU - Lieberman,Abraham N, AU - Okun,Michael S, AU - Rodriguez,Ramon L, AU - Merritt,Stacy, AU - Swartz,Camille Louise, AU - Martin,W R Wayne, AU - King,Pamela, AU - Stover,Natividad, AU - Guthrie,Stephanie, AU - Watts,Ray L, AU - Ahmed,Anwar, AU - Fernandez,Hubert H, AU - Winters,Adrienna, AU - Mari,Zoltan, AU - Dawson,Ted M, AU - Dunlop,Becky, AU - Feigin,Andrew S, AU - Shannon,Barbara, AU - Nirenberg,Melissa Jill, AU - Ogg,Mattson, AU - Ellias,Samuel A, AU - Thomas,Cathi-Ann, AU - Frei,Karen, AU - Bodis-Wollner,Ivan, AU - Glazman,Sofya, AU - Mayer,Thomas, AU - Hauser,Robert A, AU - Pahwa,Rajesh, AU - Langhammer,April, AU - Ranawaya,Ranjit, AU - Derwent,Lorelei, AU - Sethi,Kapil D, AU - Farrow,Buff, AU - Prakash,Rajan, AU - Litvan,Irene, AU - Robinson,Annette, AU - Sahay,Alok, AU - Gartner,Maureen, AU - Hinson,Vanessa K, AU - Markind,Samuel, AU - Pelikan,Melisa, AU - Perlmutter,Joel S, AU - Hartlein,Johanna, AU - Molho,Eric, AU - Evans,Sharon, AU - Adler,Charles H, AU - Duffy,Amy, AU - Lind,Marlene, AU - Elmer,Lawrence, AU - Davis,Kathy, AU - Spears,Julia, AU - Wilson,Stephanie, AU - Leehey,Maureen A, AU - Hermanowicz,Neal, AU - Niswonger,Shari, AU - Shill,Holly A, AU - Obradov,Sanja, AU - Rajput,Alex, AU - Cowper,Marilyn, AU - Lessig,Stephanie, AU - Song,David, AU - Fontaine,Deborah, AU - Zadikoff,Cindy, AU - Williams,Karen, AU - Blindauer,Karen A, AU - Bergholte,Jo, AU - Propsom,Clara Schindler, AU - Stacy,Mark A, AU - Field,Joanne, AU - Mihaila,Dragos, AU - Chilton,Mark, AU - Uc,Ergun Y, AU - Sieren,Jeri, AU - Simon,David K, AU - Kraics,Lauren, AU - Silver,Althea, AU - Boyd,James T, AU - Hamill,Robert W, AU - Ingvoldstad,Christopher, AU - Young,Jennifer, AU - Thomas,Karen, AU - Kostyk,Sandra K, AU - Wojcieszek,Joanne, AU - Pfeiffer,Ronald F, AU - Panisset,Michel, AU - Beland,Monica, AU - Reich,Stephen G, AU - Cines,Michelle, AU - Zappala,Nancy, AU - Rivest,Jean, AU - Zweig,Richard, AU - Lumina,L Pepper, AU - Hilliard,Colette Lynn, AU - Grill,Stephen, AU - Kellermann,Marye, AU - Tuite,Paul, AU - Rolandelli,Susan, AU - Kang,Un Jung, AU - Young,Joan, AU - Rao,Jayaraman, AU - Cook,Maureen M, AU - Severt,Lawrence, AU - Boyar,Karyn, PY - 2014/3/26/entrez PY - 2014/3/26/pubmed PY - 2014/7/8/medline SP - 543 EP - 52 JF - JAMA neurology JO - JAMA Neurol VL - 71 IS - 5 N2 - IMPORTANCE: Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson disease (PD) models to reduce the loss of dopamine neurons, and was safe and well tolerated in early-phase human studies. A previous phase II study suggested possible clinical benefit. OBJECTIVE: To examine whether CoQ10 could slow disease progression in early PD. DESIGN, SETTING, AND PARTICIPANTS: A phase III randomized, placebo-controlled, double-blind clinical trial at 67 North American sites consisting of participants 30 years of age or older who received a diagnosis of PD within 5 years and who had the following inclusion criteria: the presence of a rest tremor, bradykinesia, and rigidity; a modified Hoehn and Yahr stage of 2.5 or less; and no anticipated need for dopaminergic therapy within 3 months. Exclusion criteria included the use of any PD medication within 60 days, the use of any symptomatic PD medication for more than 90 days, atypical or drug-induced parkinsonism, a Unified Parkinson's Disease Rating Scale (UPDRS) rest tremor score of 3 or greater for any limb, a Mini-Mental State Examination score of 25 or less, a history of stroke, the use of certain supplements, and substantial recent exposure to CoQ10. Of 696 participants screened, 78 were found to be ineligible, and 18 declined participation. INTERVENTIONS: The remaining 600 participants were randomly assigned to receive placebo, 1200 mg/d of CoQ10, or 2400 mg/d of CoQ10; all participants received 1200 IU/d of vitamin E. MAIN OUTCOMES AND MEASURES: Participants were observed for 16 months or until a disability requiring dopaminergic treatment. The prospectively defined primary outcome measure was the change in total UPDRS score (Parts I-III) from baseline to final visit. The study was powered to detect a 3-point difference between an active treatment and placebo. RESULTS: The baseline characteristics of the participants were well balanced, the mean age was 62.5 years, 66% of participants were male, and the mean baseline total UPDRS score was 22.7. A total of 267 participants required treatment (94 received placebo, 87 received 1200 mg/d of CoQ10, and 86 received 2400 mg/d of CoQ10), and 65 participants (29 who received placebo, 19 who received 1200 mg/d of CoQ10, and 17 who received 2400 mg/d of CoQ10) withdrew prematurely. Treatments were well tolerated with no safety concerns. The study was terminated after a prespecified futility criterion was reached. At study termination, both active treatment groups showed slight adverse trends relative to placebo. Adjusted mean changes (worsening) in total UPDRS scores from baseline to final visit were 6.9 points (placebo), 7.5 points (1200 mg/d of CoQ10; P = .49 relative to placebo), and 8.0 points (2400 mg/d of CoQ10; P = .21 relative to placebo). CONCLUSIONS AND RELEVANCE: Coenzyme Q10 was safe and well tolerated in this population, but showed no evidence of clinical benefit. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00740714. SN - 2168-6157 UR - https://www.unboundmedicine.com/medline/citation/24664227/full_citation L2 - http://archneur.jamanetwork.com/article.aspx?doi=10.1001/jamaneurol.2014.131 ER -