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

Parkinson Disease Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease

Status Terminated

Clinical Trial 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.

Clinical Trial 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, and progression of symptom burden. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT03971617
• Study type: Interventional
• Source: Stony Brook University
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: May 29, 2019
• Completion date: April 29, 2021