Back to resultsClinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydrogen
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility 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
Sites / Locations
- Stony Brook University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrogen tablets
Placebo tablets
Arm Description
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.
effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03971617
Brief Title
Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment to answer research question
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
April 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrogen tablets
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo tablets
Arm Type
Placebo Comparator
Arm Description
effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water
Intervention Type
Drug
Intervention Name(s)
Hydrogen
Intervention Description
each hydrogen tablet contains 80mg magnesium
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
matching placebo tablet
Primary Outcome Measure Information:
Title
Number of Treatment-emergent Adverse Events
Description
Number of treatment-emergent adverse events [safety and tolerability] of H2-enriched water in patients with Parkinson's disease (PD).
Time Frame
56 weeks
Secondary Outcome Measure Information:
Title
Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
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.
Time Frame
56 weeks
Title
Score on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Description
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.
Time Frame
56 weeks
Title
Score on the Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
56 weeks
Title
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)
Description
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.
Time Frame
56 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carine Maurer, MD,PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8121
Country
United States
12. IPD Sharing Statement
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Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
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