Glutathione (GSH) In The Treatment of Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Glutathione (GSH) In The Treatment of Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177319
• Other study ID #: GSH
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2010
• Last updated: August 6, 2010
• Start date: September 2003
• Est. completion date: March 2007

Study information

• Verified date: January 2007
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Clinical Assessment Assessments will be done at baseline and at the end of one, two, three and four weeks during administration of drug and eight and twelve weeks after initiation of the trial. Patients will be asked to come to the clinic at approximately the same time of day for each infusion. The assessments will be done each Friday throughout the trial, once prior to the infusion of the glutathione/placebo and again one hour after the infusion. The following assessments will be done: Unified Parkinson's Disease Rating Scale, timed walking test, tapping test and clinical global assessment by both the physician and the patient. Patient diaries and the Parkinson's Disease Questionnaire, a quality of life measurement, will be done weekly. Patients will also be videotaped using a standard protocol. The treating physician will not be doing the assessments, all assessments will be done by a blinded investigator. Assessment forms can be found in the appendix.

Safety Assessments Vital signs - orthostatic, supine and standing blood pressure and pulse will be taken at baseline and again 10 minutes after the completion of each IV infusion.

ECG - an ECG will be done prior to the first infusion and approximately 10 minutes after the completion of each infusion.

Adverse Reactions Adverse events will be reported according to FDA regulations. Known side effects of intravenous GSH include difficulty administering the drug intravenously which can cause some discomfort or bruising at the site of needle entry, the formation of a small blood clot or swelling of the vein and surrounding tissues, bleeding from the puncture site and on rare occasions fainting or infection. Side effects of glutathione include fatigue and gastrointestinal disturbances. Adverse reactions will be assessed through an open patient inquiry at each visit. Patients will also be instructed to call the PI in the event of any adverse effects throughout the study.

Statistical Analysis The GSH and placebo groups will be compared on all measures using nonparametric statistics. Mann-Whitney U comparisons for independent samples will be used to detect differences between the two groups. Significance will be p<0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Glutathione

Locations

Country	Name	City	State
United States	USF Parkinson's Disease and Movement Disorders Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Wellness Health & Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed walking test
Primary	Tapping test
Secondary	CGI-clinical global assessment by both the physician and the patient
Secondary	Patient diaries
Secondary	Parkinson's Disease Questionnaire, a quality of life measurement