Glutathione (GSH) In The Treatment of Parkinson's Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of South Florida
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Timed walking test
Study Overview
Brief Summary
This is an investigator initiated pilot study to examine the effects of GSH in PD. The goal of this study is to acquire some basic data regarding side effects and efficacy of this compound to determine if this is a possible treatment option that could be recommended to interested PD patients.
Detailed Description
Inclusion Criteria Idiopathic Parkinson's disease (2 of 3 of the cardinal symptoms, tremor, bradykinesia, rigidity) Mini Mental State Examination > 24 Anti-parkinsonian medications stable for one month Hoehn and Yahr II-IV
Exclusion Criteria Atypical parkinsonism History of seizure, drug addiction Use of typical neuroleptics Previous use of glutathione
Methods Study Design The study will be a parallel, double-blind, placebo controlled trial lasting one month with three glutathione injections per week. Glutathione will be supplied by Wellness Health and Pharmaceuticals in Birmingham, Alabama.
Drug Administration The drug or a placebo (1:1 ratio) will be administered intravenously at doses of 1400 mg on Monday, Wednesday and Friday of each week for a four-week period. The drug will be infused by an intravenous push over 10 minutes and will be diluted in 10cc of normal saline. Therefore, there will be twelve intravenous infusions of either GSH or placebo.
Randomization Randomization will be done by computerized techniques assigning either GSH or placebo for a four-week period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Idiopathic Parkinson's disease (2 of 3 of the cardinal symptoms:tremor, bradykinesia, rigidity)
- •Mini Mental State Examination > 24
- •Anti-parkinsonian medications stable for one month
- •Hoehn and Yahr II-IV
- •Age 18 and above
Exclusion Criteria
- •Atypical parkinsonism
- •History of seizure, drug addiction
- •Use of typical neuroleptics
- •Previous use of glutathione
Outcomes
Primary Outcomes
Timed walking test
Tapping test
Secondary Outcomes
- CGI-clinical global assessment by both the physician and the patient
- Patient diaries
- Parkinson's Disease Questionnaire, a quality of life measurement