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Intranasal Glutathione in Parkinson's Disease

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. Identifier: NCT01398748
Recruitment Status : Completed
First Posted : July 21, 2011
Last Update Posted : July 31, 2017
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Bastyr University

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease (PD) Drug: Intranasal glutathione - (in)GSH Drug: Saline Intranasal Delivery Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's Disease
Study Start Date : July 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Arm Intervention/treatment
Active Comparator: 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
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

Active Comparator: 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
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

Placebo Comparator: 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
Drug: Saline Intranasal Delivery
Saline administration 1ml 3x/day 12 weeks in 15 participants

No Intervention: Watchful waiting
No intervention, watchful waiting only (n=4)

Primary Outcome Measures :
  1. Determination of Safety [ Time Frame: 12 weeks ]

    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.

  2. Determination of Tolerability [ Time Frame: 12 weeks ]
    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 :
  1. Description of systemic absorption characteristics [ Time Frame: 12 weeks ]
    Red blood cell GSH levels will be measured at baseline, 4 weeks, and 12 weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01398748

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United States, Washington
Bastyr Clinical Research Center
Kenmore, Washington, United States, 98023
Sponsors and Collaborators
Bastyr University
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Laurie Mischley, ND Bastyr University

Additional Information:
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Responsible Party: Bastyr University Identifier: NCT01398748     History of Changes
Other Study ID Numbers: BU-H32B11
5K01AT004404 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017

Keywords provided by Bastyr University:
Parkinson's disease

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