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 : Recruiting
First Posted : June 3, 2019
Last Update Posted : October 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|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)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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
- 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.
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
|Contact: Sandra Skinner, PhDfirstname.lastname@example.org|
|Contact: Carine Maurer, MD,PhD||631-444-2599||Carine.email@example.com|
|United States, New York|
|Stony Brook University Medical Center||Recruiting|
|Stony Brook, New York, United States, 11794-8121|
|Contact: Sandra Skinner 631-444-7513 firstname.lastname@example.org|
|Principal Investigator: Carine Maurer, MD,PhD|
|Principal Investigator:||Carine Maurer, MD,PhD||Stony Brook University|