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Randomized, double-blind, pilot evaluation of intravenous glutathione in Parkinson's disease

Authors

  • Robert A. Hauser MD,

    Corresponding author
    1. Department of Neurology, University of South Florida and Tampa General Healthcare, NPF Center of Excellence, Tampa, Florida
    2. Department of Molecular Pharmacology and Physiology, University of South Florida and Tampa General Healthcare, NPF Center of Excellence, Tampa, Florida
    • Parkinson's Disease and Movement Disorders Center, University of South Florida, 5 Tampa General Circle, Suite 410, Tampa, Florida 33606===

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  • Kelly E. Lyons PhD,

    1. Department of Neurology, University of Kansas Medical Center, NPF Center of Excellence, Florida
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  • Terry McClain ARNP,

    1. Department of Neurology, University of South Florida and Tampa General Healthcare, NPF Center of Excellence, Tampa, Florida
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  • Summer Carter MSPH,

    1. Department of Neurology, University of South Florida and Tampa General Healthcare, NPF Center of Excellence, Tampa, Florida
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  • David Perlmutter MD

    1. Perlmutter Health Center, Naples, Florida
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  • Potential conflict of interest: All authors have indicated that they have nothing to disclose regarding Wellness Health and Pharmaceuticals or glutathione. Dr. Robert Hauser has received honoraria or consulting fees from Bayer Schering Pharma AG, Bertek, Boehringer Ingelheim, Centopharm, Eisai, Genzyme, GlaxoSmithKline, Impax, Kyowa Pharmaceutical, Merck KgaA, Ortho McNeil, Novartis, Pfizer, Prestwick, Schwarz Pharma, Schering, Solvay, Synosia, Teva Neuroscience, Valeant, and Vernalis. Dr. Kelly Lyons has received honoraria or consulting fees from Advanced Neuromodulation Systems, GlaxoSmithKline, Novartis, Teva Neuroscience, UCB Pharma, and Valeant Pharmaceuticals. Terry McClain has received honoraria or consulting fees from Eisai, GlaxoSmithKline, Kyowa Pharmaceutical, Solvay, Teva Neuroscience, Serono, and Vernalis. Summer Carter has received honoraria or consulting fees from Solvay and Asubio Pharmaceuticals. Dr. David Perlmutter reports nothing to disclose.

Abstract

The objective of this study was to evaluate the safety, tolerability, and preliminary efficacy of intravenous glutathione in Parkinson's disease (PD) patients. This was a randomized, placebo-controlled, double-blind, pilot trial in subjects with PD whose motor symptoms were not adequately controlled with their current medication regimen. Subjects were randomly assigned to receive intravenous glutathione 1,400 mg or placebo administered three times a week for 4 weeks. Twenty-one subjects were randomly assigned, 11 to glutathione and 10 to placebo. One subject who was assigned to glutathione withdrew from the study for personal reasons prior to undergoing any postrandomization efficacy assessments. Glutathione was well tolerated and there were no withdrawals because of adverse events in either group. Reported adverse events were similar in the two groups. There were no significant differences in changes in Unified Parkinson's Disease Rating Scale (UPDRS) scores. Over the 4 weeks of study medication administration, UPDRS ADL + motor scores improved by a mean of 2.8 units more in the glutathione group (P = 0.32), and over the subsequent 8 weeks worsened by a mean of 3.5 units more in the glutathione group (P = 0.54). Glutathione was well tolerated and no safety concerns were identified. Preliminary efficacy data suggest the possibility of a mild symptomatic effect, but this remains to be evaluated in a larger study. © 2009 Movement Disorder Society

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