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

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

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Hydrogen; Drug: Placebo oral tablet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrogen tablets; The ingredient in the tablet producing H2 is magnesium. Each tablet contains 80 mg magnesium, a safe level well below the recommended daily dietary allowance of 420 mg for men/ 320 mg for women. Dissolving one tablet in 250 mL of water will achieve a saturating H2 concentration of approximately 1.6 ppm. Twice a day subjects will dissolve a tablet into water and drink the effervescent water.	Drug: Hydrogen; each hydrogen tablet contains 80mg magnesium
Placebo Comparator: Placebo tablets; effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water	Drug: Placebo oral tablet; matching placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-emergent Adverse Events	Number of treatment-emergent adverse events [safety and tolerability] of H2-enriched water in patients with Parkinson's disease (PD).	56 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Change from baseline to week 56 in motor examination, as assessed by score on Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part III of the MDS-UPDRS assesses the motor signs of Parkinson's Disease. Scores range from 0-33 with a lower score indicating less severe impairment.	56 weeks
Score on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)	Change from baseline to week 56 in Parkinson's Disease-related quality of life as assessed by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39). The PDQ-39 assesses how often patients experience difficulties across 8 quality of life domains (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). Scores for each domain range from 0 to 100 with lower scores indicating more impaired quality of life. The overall score is an average of the scores for the 8 dimensions.	56 weeks
Score on the Montreal Cognitive Assessment (MoCA)	Change from baseline to week 56 in overall cognitive function as assessed by the Montreal Cognitive Assessment (MoCA) score. Scores on the MoCA range from 0-30 with lower scores indicating more cognitive impairment.	56 weeks
Score on the Combined Part I, Part II, Part III, and Part IV Subscales of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Change from baseline to week 56 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS consists of four sub-scales. For each sub-scale, lower scores indicate less severe impairment. The scales are: Part I, non-motor experiences of daily living (scores range from 0-52); Part II, motor experiences of daily living (scores range from 0-52); Part III, motor examination (scores range from 0-132) and part IV, motor complications (scores range from 0-24). Score for the total assessment ranges from 0 to 260 with lower scores indicating less severe impairment.	56 weeks

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Carine Maurer, MD,PhD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): April 29, 2021
• Study Completion (Actual): April 29, 2021

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: H2PD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No