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Intranasal Glutathione in Parkinson's Disease

Primary Purpose

Parkinson's Disease (PD)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intranasal glutathione - (in)GSH
Intranasal glutathione - (in)GSH
Saline Intranasal Delivery
Sponsored by
Bastyr University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease (PD) focused on measuring Parkinson's disease, Neuroprotection, Glutathione, Intranasal

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bastyr Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Intranasal GSH 100mg/ml

Intranasal glutathione 200mg/ml

Saline intranasal delivery

Watchful waiting

Arm Description

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

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

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

No intervention, watchful waiting only (n=4)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Description of systemic absorption characteristics
Red blood cell GSH levels will be measured at baseline, 4 weeks, and 12 weeks.

Full Information

First Posted
July 19, 2011
Last Updated
July 27, 2017
Sponsor
Bastyr University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01398748
Brief Title
Intranasal Glutathione in Parkinson's Disease
Official Title
A Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bastyr University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease (PD)
Keywords
Parkinson's disease, Neuroprotection, Glutathione, Intranasal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intranasal GSH 100mg/ml
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intranasal glutathione 200mg/ml
Arm Type
Active Comparator
Arm Description
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
Arm Title
Saline intranasal delivery
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Watchful waiting
Arm Type
No Intervention
Arm Description
No intervention, watchful waiting only (n=4)
Intervention Type
Drug
Intervention Name(s)
Intranasal glutathione - (in)GSH
Intervention Description
Intranasal glutathione-Tripeptide glutathione 100 mg/ml. 1 ml 3x per day TID X 12 weeks at 2100mg in 15 participants
Intervention Type
Drug
Intervention Name(s)
Intranasal glutathione - (in)GSH
Intervention Description
Intranasal Glutathione-Tripeptide glutathione - 200mg/ml. 1 ml 3x per day TID X 12 weeks at 4200mg in 15 participants
Intervention Type
Drug
Intervention Name(s)
Saline Intranasal Delivery
Intervention Description
Saline administration 1ml 3x/day 12 weeks in 15 participants
Primary Outcome Measure Information:
Title
Determination of Safety
Description
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.
Time Frame
12 weeks
Title
Determination of Tolerability
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Description of systemic absorption characteristics
Description
Red blood cell GSH levels will be measured at baseline, 4 weeks, and 12 weeks.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Parkinson's Disease made by neurologist within previous 10 years Modified Hoehn and Yahr Stage <3 Age >20 Subjects must be able to attend study visits at screening, baseline, weeks 4, 8, 12, 16 Subjects must be able to demonstrate self-administration of study medication or have active caregiver who can administer daily. Dose and frequency of all pharmaceutical medications must be stable for one month prior to enrollment. Diet, exercise and supplementation must be kept constant throughout participation in study Ability to read and speak English Exclusion Criteria: Dementia as evidenced by Montreal Cognitive Assessment (MoCA) <24 Diseases with features common to Parkinson's Disease (eg. essential tremor, multiple system atrophy, progressive supranuclear palsy) Epilepsy History of stroke, CVA Elevated levels of ALT, AST, BUN or creatinine Chronic sinusitis as defined by SNOT-20 score >1.0 on items 1-10. Presence of other serious illness History of brain surgery History of structural brain damage History of intranasal telangiectasia Supplementation with glutathione and agents shown to increase glutathione will not be permitted and will require a 90 day washout period. Pregnant or at risk of becoming pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Mischley, ND
Organizational Affiliation
Bastyr University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bastyr Clinical Research Center
City
Kenmore
State/Province
Washington
ZIP/Postal Code
98023
Country
United States

12. IPD Sharing Statement

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Intranasal Glutathione in Parkinson's Disease

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