CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Reduced Glutathione 100mg +2 moredrug
Likely dose
Reduced Glutathione 100mgfrom 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/NCT02424708
NCT02424708Phase 2Completed
CompareCT.gov

Phase IIb Study of Intranasal Glutathione in Parkinson's Disease

Bastyr University·interventional·Posted Apr 23, 2015·Updated Jun 24, 2016

In Brief

A Phase 2 clinical trial evaluating Reduced Glutathione 100mg, Reduced Glutathione 200mg, and 1 other intervention for Parkinson's Disease. Completed, enrolled 45 participants across 2 sites.

Detailed Summary

Glutathione is an important nutrient for brain function and loss of glutathione has been implicated in Parkinson's disease. Glutathione is an antioxidant made in the body out of three amino acids, the nutrients that make up protein. This study will determine whether administration of either dose of glutathione, as a nasal spray, improves PD symptoms over time in a population of individuals with Parkinson's disease (PD).

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 23, 2015
Enrollment StartApr 1, 2015
Primary CompletionMar 1, 2016
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.2 years ago

Interventions

Reduced Glutathione 100mgdrug

100mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.

Reduced Glutathione 200mgdrug

200mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.

Placebodrug

Saline delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.