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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03971617
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Carine Maurer, Stony Brook University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Hydrogen Drug: Placebo oral tablet Phase 2 Phase 3

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, progression of symptom burden, and progression of neuromelanin-related MRI signal.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. To determine the incidence of treatment-emergent adverse events [safety and tolerability] of H2-enriched water in patients with Parkinson's disease (PD). [ Time Frame: 56 weeks ]
    Incidence of treatment-emergent adverse events will be assessed


Secondary Outcome Measures :
  1. 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 MDS-UPDRS

  2. 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 PDQ-39

  3. Score on the Montreal Cognitive Assessment (MoCA) test [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in overall cognitive function as assessed by MoCA score

  4. Score on the combined Part I, Part II, Part III, and Part IV subscales of the MDS-UPDRS [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in non-motor experiences of daily living, motor experiences of daily living, motor symptoms, and motor complications, as assessed by scores on Parts I, II, III and IV, respectively of the MDS-UPDRS

  5. Progression of neuromelanin-related MRI signal [ Time Frame: 56 weeks ]
    Change from baseline to week 56 in neuromelanin-related MRI signal


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971617


Contacts
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Contact: Diana Kaell, BA 631-444-7832 diana.kaell@stonybrookmedicine.edu
Contact: Carine Maurer, MD,PhD 631-444-2599 Carine.maurer@stonybrookmedicine.edu

Locations
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United States, New York
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794-8121
Contact: Diana Kaell    631-444-7832    diana.kaell@stonybrookmedicine.edu   
Principal Investigator: Carine Maurer, MD,PhD         
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Carine Maurer, MD,PhD Stony Brook University
More Information
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Responsible Party: Carine Maurer, Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT03971617    
Other Study ID Numbers: H2PD
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases