NCT01398748

Intranasal Glutathione in Parkinson's Disease

A Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Bastyr University · Academic / Other
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Individuals will be randomized to one of three treatment (100 mg GSH/ ml, 200 mg GSH/ ml, or placebo) arms in a double-blind fashion. All study medication will be administered 1 ml three times daily for three months, with a one-month wash out.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2011-07-21
• Last updated: 2017-07-31

Locations

1 site across 1 country: United States