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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02424708
First Posted: April 23, 2015
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Bastyr University
  Purpose
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).

Condition Intervention Phase
Parkinson's Disease Drug: Reduced Glutathione 100mg Drug: Reduced Glutathione 200mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIb Study of Intranasal Glutathione in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Bastyr University:

Primary Outcome Measures:
  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score [ Time Frame: 12 weeks ]

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

Enrollment: 45
Study Start Date: April 2015
Study Completion Date: April 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: (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 Name: (in)GSH

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424708


Locations
United States, Washington
Bastyr University
Kenmore, Washington, United States, 98028
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Bastyr University
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Laurie K Mischley, NDMPHPhD(c) Bastyr University
  More Information

Publications:

Responsible Party: Bastyr University
ClinicalTrials.gov Identifier: NCT02424708     History of Changes
Other Study ID Numbers: 14-1443
First Submitted: April 15, 2015
First Posted: April 23, 2015
Last Update Posted: October 12, 2017
Last Verified: June 2016

Keywords provided by Bastyr University:
Reduced Glutathione
Intranasal
(in)GSH
Parkinson's Disease
Glutathione
Uptake
central nervous system

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases