Phase IIb Study of Intranasal Glutathione in Parkinson's Disease ((in)GSH)

June 23, 2016 updated by: Bastyr University
Glutathione is an important nutrient for brain function and loss of glutathione has been implicated in Parkinson's disease. Glutathione is an antioxidant made in the body out of three amino acids, the nutrients that make up protein. This study will determine whether administration of either dose of glutathione, as a nasal spray, improves PD symptoms over time in a population of individuals with Parkinson's disease (PD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study begins with a pre-screening telephone interview. During this conversation participants will be asked a series of questions that will help us identify whether they are eligible for participation in this study. The pre-screening interview process will take approximately 10 minutes and will include all screening criteria that does not require clinical or laboratory examination

All routine research visits will take place at Bastyr University Campus (Kenmore, WA). Participants will be asked to schedule visits at approximately the same time of day each visit .If they are on medications, we would like them to take their medications as they normally would on the day of the visit. Participants will be randomly assigned to one of three different study groups- a low dose group, a high dose group, or a placebo group.

Study participants will invited to volunteer for two magnetic resonance imagine (MRI) scans as part of this study, an optional part of study participation. For those who volunteer and qualify, MRIs will be performed at the University of Washington Radiology Department early in the morning. One scan will be taken at baseline before taking glutathione and the second upon completion of the study medication. There will be a separate consent form for those who participate in the imaging portion of this study. Among the participants who volunteer, the first 15 to qualify for an MRI scan will be scheduled according to MRI availability.

If participants are enrolled in the study, they will be asked to keep a daily log of actual frequency of administration of study medication, if any, as well as any changes in their PD symptoms, any adverse events they might experience, and their general well-being. We are giving participants enough medication to last four weeks, until the date of their next appointment. The medication should be taken three times a day (morning, afternoon, and evening).

Visit 1- Baseline: (Approximately 1 hour)

  • Urine sample
  • Venipuncture (blood draw, (40 mL / ~3 Tbsp) to assess blood antioxidant status..
  • Clinical assessment of PD severity: Unified Parkinson's Disease Rating Scale (UPDRS), which involves assessing degree of tremor, ability to walk across the room, questions about ability to function independently (i.e. button your own shirt, feed yourself), and questions about mental health, including depression and intellectual impairment.
  • Participant will be taught how and when to administer the study medication and be given a 1-month supply.

Visit 2- Week 4 follow-up: (Approximately 1 hour)

  • Urine sample
  • Venipuncture (blood draw, (40 mL / ~3 Tbsp) to assess blood antioxidant status..
  • Clinical assessment of PD severity: Unified Parkinson's Disease Rating Scale (UPDRS) and Webster-Step Second test involve assessing degree of tremor, ability to walk across the room, questions about ability to function independently (i.e. button your own shirt, feed yourself), and questions about mental health, including depression and intellectual impairment.
  • Participant will be asked to return any unused study medication and applicator tips from the first month of the study and be given the next 1-month supply.
  • We will inquire about medication changes and collect medication use logs.

Visit 3- Week 8 follow-up: (Approximately 1/2 hour)

  • Participant will be asked to return any unused study medication from the second month of the study and be given the next 1-month supply.
  • We will inquire about medication changes and collect medication use logs.

Visit 4- Week 12 follow-up: (Approximately 1 hour)

  • Urine sample
  • Venipuncture (blood draw, (40 mL / ~3 Tbsp) to assess blood antioxidant status..
  • Clinical assessment of PD severity: Unified Parkinson's Disease Rating Scale (UPDRS) to assess degree of tremor, ability to walk across the room, questions about ability to function independently (i.e. button your own shirt, feed yourself), and questions about mental health, including depression and intellectual impairment.
  • Participants will be asked to return any unused study medication from the third month of the study.
  • We will inquire about medication changes and collect medication use logs.

Visit 5- Week 16 follow-up: (Approximately 1 hour)

This visit is included to determine whether there are any lasting effects of the study medication one month following discontinuation of use. The visit will include:

  • Urine sample
  • Venipuncture (blood draw, (40 mL / ~3 Tbsp) to assess blood antioxidant status..
  • Clinical assessment of PD severity: Unified Parkinson's Disease Rating Scale (UPDRS) which involves assessing degree of tremor, ability to walk across the room, questions about ability to function independently (i.e. button your own shirt, feed yourself), and questions about mental health, including depression and intellectual impairment.

Overall, approximately 5 hours will be required for study participation. Blood draws will occur at most, but not all visits, and will not exceed 4 Tbsp per month.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Kenmore, Washington, United States, 98028
        • Bastyr University
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of PD made by a clinical neurologist within the previous 10 years
  • A modified Hoehn & Yahr Stage <3
  • Age >21
  • Subjects must be able to attend study visits at baseline, weeks 4, 8, 12, and 16.
  • Subjects must be able to demonstrate, or have a caregiver administer, medication.
  • Dose and frequency of pharmaceutical medications must be stable for 1 month prior to enrollment.
  • Dose and frequency of naturopathic medications must be stable for 1 month prior to enrollment.
  • Diet, exercise, and medications must be kept constant throughout participation in the study. (Medication changes considered essential by a participant's physician will be permitted and recorded).
  • Ability to read and speak English.
  • MRI cohort: Additional inclusion criteria specific to MRI.

Exclusion Criteria:

  • Dementia as evidenced by a Montreal Cognitive Assessment score of less than 24.
  • Diseases with features common to PD (e.g., essential tremor, multiple system atrophy, progressive supranuclear palsy)
  • Epilepsy
  • A history of stroke
  • The presence of other serious illnesses
  • Respiratory disease (e.g. asthma, COPD)
  • A history of brain surgery
  • A history of structural brain disease
  • A history of intranasal telangiectasia
  • Supplementation with glutathione, and agents shown to increase glutathione, will not be permitted and their use will necessitate a 90-day washout period; this will be required for all forms of glutathione and the glutathione precursor, N-acetylcysteine.
  • Pregnant or at risk of becoming pregnant (i.e., unwilling to use birth control if a sexually active, pre-menopausal female). Urine pregnancy tests will be administered to pre-menopausal women.
  • MRI cohort: Additional exclusion criteria specific to MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
The study medication is packaged in sterile 1 ml pre-filled syringes, containing saline, which will be delivered intranasally.
Drug: Placebo
Saline delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
Other Names:
  • Saline
Active Comparator: Reduced Glutathione 100mg
The study medication is packaged in sterile 1 ml pre-filled syringes, containing 100 mg/ml of reduced glutathione (GSH), which will be delivered intranasally.
Drug: Reduced Glutathione 100mg
100mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
Other Names:
  • (in)GSH
Active Comparator: Reduced Glutathione 200mg
The study medication is packaged in sterile 1 ml pre-filled syringes, containing 200 mg/ml of reduced glutathione (GSH), which will be delivered intranasally.
Drug: Reduced Glutathione 200mg
200mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
Other Names:
  • (in)GSH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Red blood cell (RBC) GSH levels will be measured at baseline, week 4, week 12, and 16.
Time Frame: up to 16 weeks
up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bastyr University

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Laurie K Mischley, NDMPHPhD(c), Bastyr University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-1443 (Other Identifier: University of Colorado, Denver)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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