title: A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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
  Coenzyme Q10 was safe and well tolerated in this population, but showed no evidence of clinical benefit.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00740714.
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authors.forename: Stephen
authors.initials: S
authors.lastname: Grill
authors.affiliation: Parkinson and Movement Disorders Center of Maryland, Elkridge.
authors.forename: Marye
authors.initials: M
authors.lastname: Kellermann
authors.affiliation: Department of Neurology, University of Minnesota, Minneapolis.
authors.forename: Paul
authors.initials: P
authors.lastname: Tuite
authors.affiliation: Department of Neurology, University of Minnesota, Minneapolis.
authors.forename: Susan
authors.initials: S
authors.lastname: Rolandelli
authors.affiliation: Department of Neurology, University of Chicago, Chicago, Illinois.
authors.forename: Un Jung
authors.initials: UJ
authors.lastname: Kang
authors.affiliation: Department of Neurology, University of Chicago, Chicago, Illinois.
authors.forename: Joan
authors.initials: J
authors.lastname: Young
authors.affiliation: Department of Neurology, Ochsner Clinic Foundation, New Orleans, Louisiana.
authors.forename: Jayaraman
authors.initials: J
authors.lastname: Rao
authors.affiliation: Department of Neurology, Ochsner Clinic Foundation, New Orleans, Louisiana.
authors.forename: Maureen M
authors.initials: MM
authors.lastname: Cook
authors.affiliation: Department of Neurology, Beth Israel Medical Center, New York, New York.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Severt
authors.affiliation: Department of Neurology, Beth Israel Medical Center, New York, New York.
authors.forename: Karyn
authors.initials: K
authors.lastname: Boyar
mesh_terms: D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage* / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000175:diagnosis* / Q000188:drug therapy* / Q000201:enzymology; D011446:Prospective Studies; D016896:Treatment Outcome; D014451:Ubiquinone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood
chemical_list: D000975:Antioxidants; D014451:Ubiquinone; C024989:coenzyme Q10