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Intranasal Glutathione in Parkinson's Disease

NCT01398748 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-07-31

No results posted yet for this study

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 delivery for this popular CAM therapy 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 safety, tolerability, and preliminary absorption data of (in)GSH in volunteers with PD in a Phase I single ascending dose escalation study.

Conditions

  • Parkinson's Disease (PD)

Interventions

DRUG

Intranasal glutathione - (in)GSH

Intranasal glutathione-Tripeptide glutathione 100 mg/ml. 1 ml 3x per day TID X 12 weeks at 2100mg in 15 participants

DRUG

Intranasal glutathione - (in)GSH

Intranasal Glutathione-Tripeptide glutathione - 200mg/ml. 1 ml 3x per day TID X 12 weeks at 4200mg in 15 participants

DRUG

Saline Intranasal Delivery

Saline administration 1ml 3x/day 12 weeks in 15 participants

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Bastyr University

    lead OTHER

Principal Investigators

  • Laurie Mischley, ND · Bastyr University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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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 NCT01398748 on ClinicalTrials.gov