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Phase IIb Study of Intranasal Glutathione in Parkinson's Disease

NCT02424708 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-06-24

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Reduced Glutathione 100mg

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.

DRUG

Reduced Glutathione 200mg

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • Bastyr University

    lead OTHER

Principal Investigators

  • Laurie K Mischley, NDMPHPhD(c) · Bastyr University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02424708 on ClinicalTrials.gov