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Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease

2019-06-05 23:47:16 | BioPortfolio

Summary

This study is a placebo-controlled, double-blind trial that will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. The medication will be administered orally as 8 ounces of hydrogen-enriched drinking water twice a day over the course of one year.

Description

This study will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. Subjects will be sequentially randomized in a 1:1 ratio to receive hydrogen-enriched water or the corresponding placebo twice a day, in addition to all standard-of-care treatments. Enrollment goal is 70 subjects. Duration of therapy is 52 weeks.

The primary outcome measures are safety and tolerability of hydrogen-enriched water. Secondary outcome measures include: progression of motor symptoms, health-related quality of life, progression of cognitive decline, progression of symptom burden, and progression of neuromelanin-related MRI signal.

Study Design

Conditions

Parkinson Disease

Intervention

Hydrogen, Placebo oral tablet

Location

Stony Brook University Medical Center
Stony Brook
New York
United States
11794-8121

Status

Recruiting

Source

Stony Brook University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-06-05T23:47:16-0400

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Disorders of the mouth attendant upon non-oral disease or injury.

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