Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT03971617 |
Recruitment Status :
Terminated
(Insufficient enrollment to answer research question)
First Posted : June 3, 2019
Last Update Posted : May 10, 2021
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Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease | Drug: Hydrogen Drug: Placebo oral tablet | Phase 2 Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 2 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 |
Actual Primary Completion Date : | April 29, 2021 |
Actual Study Completion Date : | April 29, 2021 |

Arm | Intervention/treatment |
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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.
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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
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Drug: Placebo oral tablet
matching placebo tablet |
- 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
- 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. Part III of the MDS-UPDRS assesses the motor signs of PD. 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 PDQ-39. The PDQ-39 assesses how often patients experience difficulties across 8 quality of life dimensions. Scores for each dimension 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) test [ Time Frame: 56 weeks ]Change from baseline to week 56 in overall cognitive function as assessed by 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 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 (score range 0-13), II (score range 0-13), III (score range 0-33) and IV (score range 0-6), respectively of the MDS-UPDRS. Total score ranges from 0-65 with lower scores indicating less severe impairment.

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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 |
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

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
United States, New York | |
Stony Brook University Medical Center | |
Stony Brook, New York, United States, 11794-8121 |
Principal Investigator: | Carine Maurer, MD,PhD | Stony Brook University |
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: | May 10, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |