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

What Was Tested

The trial (phase 2) is built around Glutathione for parkinson's disease.

This is an investigator initiated pilot study to examine the effects of GSH in PD.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: atypical parkinsonism; history of seizure, drug addiction; use of typical neuroleptics.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Glutathione and who got the comparison, which limits bias.

Each person switched between Glutathione and the comparison at some point, usually with a gap in between.

Neither the parkinson's disease participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2003-09 with completion listed for 2007-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Timed walking test. Tapping test.

It also tracked 3 secondary outcomes, for example CGI-clinical global assessment by both the physician and the patient, Patient diaries and Parkinson's Disease Questionnaire, a quality of life measurement.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glutathione in 20 people with parkinson's disease.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, Parkinson's disease research.