Intranasal Glutathione in Parkinson's Disease

Parkinson's Disease (PD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398748
• Other study ID #: BU-H32B11
• Secondary ID: 5K01AT004404
• Status: Completed
• Phase: Phase 1
• First received: July 19, 2011
• Last updated: July 27, 2017
• Start date: July 2012
• Est. completion date: January 2016

Study information

• Verified date: July 2017
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of Parkinson's Disease made by neurologist within previous 10 years

2. Modified Hoehn and Yahr Stage <3

3. Age >20

4. Subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12, 16

5. Subjects must be able to demonstrate self-administration of study medication or have active caregiver who can administer daily.

6. Dose and frequency of all pharmaceutical medications must be stable for one month prior to enrollment.

7. Diet, exercise and supplementation must be kept constant throughout participation in study

8. Ability to read and speak English

Exclusion Criteria:

1. Dementia as evidenced by Montreal Cognitive Assessment (MoCA) <24

2. Diseases with features common to Parkinson's Disease (eg. essential tremor, multiple system atrophy, progressive supranuclear palsy)

3. Epilepsy

4. History of stroke, CVA

5. Elevated levels of ALT, AST, BUN or creatinine

6. Chronic sinusitis as defined by SNOT-20 score >1.0 on items 1-10.

7. Presence of other serious illness

8. History of brain surgery

9. History of structural brain damage

10. History of intranasal telangiectasia

11. Supplementation with glutathione and agents shown to increase glutathione will not be permitted and will require a 90 day washout period.

12. Pregnant or at risk of becoming pregnant.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease (PD)

Intervention

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
• Intranasal glutathione - (in)GSH
Intranasal Glutathione-Tripeptide glutathione - 200mg/ml. 1 ml 3x per day TID X 12 weeks at 4200mg in 15 participants
• Saline Intranasal Delivery
Saline administration 1ml 3x/day 12 weeks in 15 participants

Locations

Country	Name	City	State
United States	Bastyr Clinical Research Center	Kenmore	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Bastyr University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Safety	1a. Laboratory monitoring for adverse events will include CBC, ALT, AST, BUN, creatinine, uric acid, and urinalysis. Data will be collected throughout the 12-week intervention and at 1-mo following cessation of the study medication.; 1b. Clinical adverse events will be measured using a daily patient diary and record score cards specifically screening for sinus irritation. Monitoring of Side Effects System (MOSES) will be used to screen for systemic and generalized adverse events.; 1c. Effect on PD symptoms will be measured by the UPDRS to screen for accelerated disease activity.	12 weeks
Primary	Determination of Tolerability	Participants will be asked to keep a daily log and unused study medication will be measured at each clinical visit. Tolerability will be measured by frequency and severity of reported adverse events and withdrawal from study. The goal will be to identify the maximum tolerated dose (MTD) which will be defined as the highest dose achieving adherence, as defined as 80% of the group taking the prescribed dose 80% of the time.	12 weeks
Secondary	Description of systemic absorption characteristics	Red blood cell GSH levels will be measured at baseline, 4 weeks, and 12 weeks.	12 weeks

External Links

•   Bastyr University Research Center