Intranasal Glutathione in Parkinson's Disease

NCT ID: NCT01398748

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-01-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intranasal GSH 100mg/ml

Study participant will be provided with monthly supply of study medication and will be asked to intake 100mg/ml of intranasal glutathione (n=15) An amount of 1ml with a frequency 3x per days and duration of 12 weeks with a dosage of 2100mg

Group Type: ACTIVE_COMPARATOR

Intranasal glutathione - (in)GSH

Intervention Type: DRUG

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

Intranasal glutathione 200mg/ml

Study participant will be provided with monthly supply of study medication and will be asked to intake 200/ml of intranasal glutathione (n=15) An amount of 1ml with a frequency 3x per days and duration of 12 weeks with a dosage of 4200mg

Group Type: ACTIVE_COMPARATOR

Intranasal glutathione - (in)GSH

Intervention Type: DRUG

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

Saline intranasal delivery

Study participant will be provided with monthly supply of study medication and will be asked to intake Intranasal saline delivery (n=15) An amount of 1ml with a frequency 3x per day with a duration of 12 weeks

Group Type: PLACEBO_COMPARATOR

Saline Intranasal Delivery

Intervention Type: DRUG

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

Watchful waiting

No intervention, watchful waiting only (n=4)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Saline Intranasal Delivery

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Bastyr University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie Mischley, ND

Role: PRINCIPAL_INVESTIGATOR

Bastyr University

Locations

Bastyr Clinical Research Center

Kenmore, Washington, United States

Countries

United States

Other Identifiers

5K01AT004404

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BU-H32B11

Identifier Type: -

Identifier Source: org_study_id