Phase IIb of Intranasal Glutathione in Parkinson’s Disease

Phase IIb of Intranasal Glutathione in Parkinson’s Disease

Project Goals

This is a Phase II study seeking to determine whether administration of different doses of glutathione or placebo, as a nasal spray, improves Parkinson’s disease (PD) symptoms over time in a population of individuals with PD.  Participants will be asked to administer the nasal spray or placebo three times daily for three months.

Participation Requirements 

Individuals must have been diagnosed with Parkinson's disease in the past 10 years, must not currently be using glutathione in any form, and must be able to come to Bastyr for five visits over four months. Study medication will be provided and participants will be reimbursed for transportation costs.

The recruitment phase is complete. We are no longer recruiting participants for this trial.

Scientific Abstract

Excessive free radical formation and depletion of the brain’s primary antioxidant, glutathione, are established components of Parkinson’s disease (PD) pathophysiology. While there is rationale for the therapeutic use of reduced glutathione (GSH) in PD, and even some preliminary evidence to suggest the use of GSH can lead to symptomatic improvement, obstacles surrounding currently employed delivery methods have hindered the clinical utility of this therapy. Intranasal GSH is a novel method of delivery in patients with PD, and bypasses the obstacles associated with other delivery methods. It has been used in clinical practice since 2005. The aim of this study is to evaluate whether administration of different doses of glutathione or placebo, as a nasal spray, improves Parkinson’s disease (PD) symptoms over time in a population of individuals with PD.

Specific Aims

Primary Aim:

  • To describe clinical outcomes associated with 300 mg/day and 600 mg/day (in)GSH.
     Primary Outcome Measure:  Change in UPDRS

Secondary Aim:

  • To describe any changes in glutathione-related biomarkers over the 12 week intervention, and obtain preliminary data as to whether or not there is a dose-response relationship.

 

Status: 
Active
Study area: 
Principal investigator: 
Laurie Mischley, ND, MPH, PhD(c)
Project period: 
12/31/2014-12/30/2016
Completed date (for sorting): 
Friday, December 30, 2016
Funded by: 
Michael J. Fox Foundation