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

Overview

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.

Full Title of Study: “A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 29, 2021

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.

Interventions

  • Drug: Hydrogen
    • each hydrogen tablet contains 80mg magnesium
  • Drug: Placebo oral tablet
    • matching placebo tablet

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: Placebo tablets
    • effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)
    • Time Frame: 56 weeks
    • 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.
  • Score on the Parkinson’s Disease Quality of Life Questionnaire (PDQ-39)
    • Time Frame: 56 weeks
    • 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.
  • Score on the Montreal Cognitive Assessment (MoCA)
    • Time Frame: 56 weeks
    • 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.
  • 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)
    • Time Frame: 56 weeks
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stony Brook University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carine Maurer, Assistant Professor – Stony Brook University
  • Overall Official(s)
    • Carine Maurer, MD,PhD, Principal Investigator, Stony Brook University

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