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A randomized, double‐blind phase I / II a study of intranasal glutathione in P arkinson's disease
Author(s) -
Mischley Laurie K.,
Leverenz James B.,
Lau Richard C.,
Polissar Nayak L.,
Neradilek Moni B.,
Samii Ali,
Standish Leanna J.
Publication year - 2015
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.26351
Subject(s) - tolerability , medicine , glutathione , placebo , adverse effect , parkinson's disease , population , pharmacology , anesthesia , disease , pathology , chemistry , biochemistry , alternative medicine , environmental health , enzyme
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. © 2015 International Parkinson and Movement Disorder Society