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Glutathione (GSH) In The Treatment of 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.
 
ClinicalTrials.gov Identifier: NCT01177319
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : August 9, 2010
Sponsor:
Collaborator:
Wellness Health & Pharmaceuticals, Inc.
Information provided by:
University of South Florida

Tracking Information
First Submitted Date  ICMJE August 5, 2010
First Posted Date  ICMJE August 9, 2010
Last Update Posted Date August 9, 2010
Study Start Date  ICMJE September 2003
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2010)
  • Timed walking test
  • Tapping test
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2010)
  • CGI-clinical global assessment by both the physician and the patient
  • Patient diaries
  • Parkinson's Disease Questionnaire, a quality of life measurement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glutathione (GSH) In The Treatment of Parkinson's Disease
Official Title  ICMJE Glutathione (GSH) In The Treatment of Parkinson's Disease
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: Glutathione
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2010)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01177319
Other Study ID Numbers  ICMJE GSH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert A. Hauser, MD, University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE Wellness Health & Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Robert A Hauser, MD, MBA University of South Florida
PRS Account University of South Florida
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP