Phase IIb Study of Intranasal Glutathione in Parkinson's Disease

What Was Tested

In this phase 2 trial, researchers set out to test Glutathione for parkinson's disease.

Glutathione is an antioxidant made in the body out of three amino acids, the nutrients that make up protein.

It had three arms (groups): Placebo (placebo comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study begins with a pre-screening telephone interview.

During this conversation participants will be asked a series of questions that will help them identify whether they are eligible for participation in this study.

Participants will be asked to schedule visits at approximately the same time of day each visit .If they are on medications, the researchers would like them to take their medications as they normally would on the day of the visit.

Study participants will invited to volunteer for two magnetic resonance imagine (MRI) scans as part of this study, an optional part of study participation.

Who Took Part

The registry lists 45 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Diagnosis of PD made by a clinical neurologist within the previous 10 years. A modified Hoehn \& Yahr Stage \<3. Subjects must be able to attend study visits at baseline, weeks 4, 8, 12, and 16. Diet, exercise, and medications must be kept constant throughout participation in the study. (Medication changes considered essential by a participant's physician will be permitted and recorded). Ability to read and speak English.

The full record lists 10 inclusion and 12 exclusion criteria; among the exclusions: dementia as evidenced by a montreal cognitive assessment score of less than 24; diseases with features common to pd (e.g., essential tremor, multiple system atrophy, progressive supranuclear palsy); A history of stroke.

How the Study Was Run

The set-up was randomized, factorial and double-blind.

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

As a double-blind Glutathione study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2015-04 with completion listed for 2016-03.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Red blood cell (RBC) GSH levels will be measured at baseline, week 4, week 12, and 16.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glutathione in 45 people with parkinson's disease.

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.