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Insufficient enrollment to answer research question
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogen tablets | Experimental | 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 tablets | Placebo Comparator | effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen | Drug | each hydrogen tablet contains 80mg magnesium |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carine Maurer, MD,PhD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Medical Center | Stony Brook | New York | 11794-8121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Hydrogen: each hydrogen tablet contains 80mg magnesium |
| FG001 | Placebo Tablets | effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water Placebo oral tablet: matching placebo tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Hydrogen: each hydrogen tablet contains 80mg magnesium |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | Adverse Events | 56 weeks |
|
56 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Hydrogen: each hydrogen tablet contains 80mg magnesium |
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Due to low enrollment in this study, we are not able to report on study outcome measures for participants and are unable to draw conclusions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra Skinner | Stony Brook University Medical Center | 631-444-7513 | sandra.skinner@stonybrookmedicine.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2020 | May 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D006859 | Hydrogen |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Placebo oral tablet |
| Drug |
matching placebo tablet |
|
| 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 |
| BG001 | Placebo Tablets | effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water Placebo oral tablet: matching placebo tablet |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water
Placebo oral tablet: matching placebo tablet
|
|
| Secondary | 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. | Note: Data cannot be reported due to privacy issues associated with low enrollment | Posted | 56 weeks |
|
|
| Secondary | 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. | Note: results cannot be reported due to privacy issues associated with low enrollment | Posted | 56 weeks |
|
|
| Secondary | 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. | Note: Data cannot be reported due to privacy issues associated with low enrollment | Posted | 56 weeks |
|
|
| Secondary | 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. | Note: Data cannot be reported due to privacy issues associated with low enrollment | Posted | 56 weeks |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo Tablets | effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water Placebo oral tablet: matching placebo tablet | 0 | 1 | 0 | 1 | 0 | 1 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |