Status:
COMPLETED
Intranasal Glutathione in Parkinson's Disease
Lead Sponsor:
Bastyr University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Parkinson's Disease (PD)
Eligibility:
All Genders
21-100 years
Phase:
PHASE1
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...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01398748
Start Date
July 1 2012
End Date
January 1 2016
Last Update
July 31 2017
Active Locations (1)
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1
Bastyr Clinical Research Center
Kenmore, Washington, United States, 98023