A randomized, double-blind phase I/IIa study of intranasal glutathione in Parkinson's disease

Mov Disord. 2015 Oct;30(12):1696-701. doi: 10.1002/mds.26351. Epub 2015 Jul 31.

Abstract

Background: Depletion of reduced glutathione is associated with PD and glutathione augmentation has been proposed as a disease-modifying strategy. The aim of this study was to determine the safety and tolerability of intranasal reduced glutathione in individuals with PD.

Methods: Thirty individuals with PD were randomized to either placebo (saline), 300 mg/day, or 600 mg/day of intranasal glutathione in three divided daily doses. Follow-up visits included side effect screening of PD symptoms and cognition, blood chemistry, sinus irritation, and hyposmia. Tolerability was measured by frequency and severity of reported adverse events, compliance, and withdrawals from the study.

Results: After 3 months, there were no substantial differences between groups in the number of adverse events reported or observed among all safety measures assessed. All groups met tolerability criteria.

Conclusions: These data support the safety and tolerability of intranasal glutathione in this population. Pharmacokinetic and dose-finding studies are warranted.

Keywords: antioxidant; deficiency; glutathione; neuroprotection; nutrition.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Administration, Intranasal
  • Antiparasitic Agents / administration & dosage*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Glutathione / administration & dosage*
  • Humans
  • Male
  • Parkinson Disease / drug therapy*
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Antiparasitic Agents
  • Glutathione