CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Reduced Glutathionedrug
Likely dose
Reduced Glutathione 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02324426
NCT02324426Phase 1Completed
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Central Nervous System Uptake of Intranasal Glutathione in Parkinson's Disease

University of Washington·interventional·Posted Dec 24, 2014·Updated Apr 30, 2015

In Brief

A Phase 1 clinical trial evaluating Reduced Glutathione for Parkinson's Disease. Completed, enrolled 15 participants across 1 site.

Detailed Summary

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, (in)GSH, is a novel method of glutathione augmentation. The aim of this study is to evaluate whether 200 mg of (in)GSH results in measurable changes in brain glutathione concentrations, as measured by magnetic resonance spectroscopy (MRS) in 15 individuals with PD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesUnited States
CollaboratorsMichael J. Fox Foundation for Parkinson's Research

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 24, 2014
Enrollment StartDec 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.5 years ago

Interventions

Reduced Glutathionedrug

200 mg GSH delivered in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.