title: Randomized, double-blind, placebo-controlled trial on symptomatic effects of coenzyme Q(10) in Parkinson disease.
abstract: BACKGROUND
  Major hallmarks in the pathophysiology of Parkinson disease are cellular energy depletion and oxidative stress leading to cellular dysfunction and death. Coenzyme Q(10) (CoQ(10)) is an electron acceptor bridging mitochondrial complexes I and II/III and a potent antioxidant that consistently partially recovers the function of dopaminergic neurons.
  
  
  OBJECTIVE
  To determine whether nanoparticular CoQ(10) is safe and displays symptomatic effects in patients with midstage Parkinson disease without motor fluctuations.
  
  
  METHODS
  Multicenter, randomized, double-blind, placebo-controlled, stratified, parallel-group, single-dose trial.
  
  
  METHODS
  Academic and nonacademic movement disorder clinics.
  
  
  METHODS
  One hundred thirty-one patients with Parkinson disease without motor fluctuations and a stable antiparkinsonian treatment. Intervention Random assignment to placebo or nanoparticular CoQ(10) (100 mg 3 times a day) for a treatment period of 3 months. Stratification criterion was levodopa treatment.
  
  
  METHODS
  The subjects underwent evaluation with the Unified Parkinson's Disease Rating Scale (UPDRS) at each visit on a monthly basis. The primary outcome variable was the change of the sum score of the UPDRS parts II and III between the baseline and 3-month visits.
  
  
  RESULTS
  One hundred thirty-one subjects were randomized according to the protocol. The mean changes of the sum UPDRS parts II/III score were -3.69 for the placebo group and -3.33 for the CoQ(10) group (P = .82). Statistical analysis according to the stratification did not result in significant changes of the primary outcome variable. No secondary outcome measure showed a significant change between the placebo group and the CoQ(10) group. The frequency and quality of adverse events were similar in both treatment groups.
  
  
  CONCLUSIONS
  Nanoparticular CoQ(10) at a dosage of 300 mg/d is safe and well tolerated and leads to plasma levels similar to 1200 mg/d of standard formulations. Add-on CoQ(10) does not display symptomatic effects in midstage Parkinson disease.
authors.affiliation: Department of Neurology, Technical University of Dresden, Fetscherstrasse 74, 01307 Dresden, Germany. Alexander.Storch@neuro.med.tu-dresden.de
authors.forename: Alexander
authors.initials: A
authors.lastname: Storch
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Jost
authors.forename: Peter
authors.initials: P
authors.lastname: Vieregge
authors.forename: Jörg
authors.initials: J
authors.lastname: Spiegel
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Greulich
authors.forename: Joachim
authors.initials: J
authors.lastname: Durner
authors.forename: Thomas
authors.initials: T
authors.lastname: Müller
authors.forename: Andreas
authors.initials: A
authors.lastname: Kupsch
authors.forename: Henning
authors.initials: H
authors.lastname: Henningsen
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Oertel
authors.forename: Gerd
authors.initials: G
authors.lastname: Fuchs
authors.forename: Wilfried
authors.initials: W
authors.lastname: Kuhn
authors.forename: Petra
authors.initials: P
authors.lastname: Niklowitz
authors.forename: Rainer
authors.initials: R
authors.lastname: Koch
authors.forename: Birgit
authors.initials: B
authors.lastname: Herting
authors.forename: Heinz
authors.initials: H
authors.lastname: Reichmann
mesh_terms: D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage* / Q000009:adverse effects; D019069:Cell Respiration / Q000187:drug effects / Q000502:physiology; D003067:Coenzymes / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D004298:Dopamine / Q000096:biosynthesis; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004734:Energy Metabolism / Q000187:drug effects / Q000502:physiology; D005260:Female; D006801:Humans; D007980:Levodopa / Q000378:metabolism / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D009474:Neurons / Q000187:drug effects* / Q000378:metabolism; D018384:Oxidative Stress / Q000187:drug effects* / Q000502:physiology; D010300:Parkinson Disease / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D010919:Placebos; D013378:Substantia Nigra / Q000187:drug effects* / Q000378:metabolism / Q000503:physiopathology; D016896:Treatment Outcome; D014451:Ubiquinone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D014815:Vitamins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics
chemical_list: D000975:Antioxidants; D003067:Coenzymes; D010919:Placebos; D014815:Vitamins; D014451:Ubiquinone; D007980:Levodopa; C024989:coenzyme Q10; D004298:Dopamine