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

• Status: Terminated
• Trial end date: 2021-04-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University

Criteria

Inclusion Criteria:

• Diagnosis of Parkinson's Disease

• Modified Hoehn & Yahr Stage < III

• Diagnosis of Parkinson's Disease made within past 3 years•

• Ability to complete questionnaires

• Willingness to go off parkinsonian medication for 12 hours prior to baseline and 56-week assessments

Exclusion Criteria:

• Other major diseases of the central nervous system

• History of stroke

• Use of antipsychotic neuroleptic medication within the last 6 months

• Symptomatic (secondary) parkinsonism

• Atypical parkinsonian variants

• Unstable medical or psychiatric illness

• Known kidney disease

• History of stereotactic brain surgery

• Significant cognitive impairment

• Inability to safely tolerate 8 ounces of water twice daily associated with the study medication

• Unable to avoid regular use of medications containing magnesium

• Treatment with another investigational drug within the last 30 days that may interfere with the study medication

• Pregnancy or nursing