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

• ClinicalTrials.gov Identifier: NCT03971617
• Recruitment Status: Terminated
• First Posted: June 3, 2019
• Last Update Posted: May 10, 2021
• Sponsor: Stony Brook University
• Information provided by (Responsible Party): Carine Maurer, Stony Brook University

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.

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, and progression of symptom burden.

Study Design

• 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

Arms and Interventions

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

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. 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.
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. 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.
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. Scores on the MoCA range from 0-30 with lower scores indicating more cognitive impairment.
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 (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.

Eligibility Criteria

• 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

Locations

United States, New York

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794-8121

Sponsors and Collaborators

Stony Brook University

Investigators

• Principal Investigator: Carine Maurer, MD,PhD; Stony Brook University

More Information

• Responsible Party: Carine Maurer, Assistant Professor, Stony Brook University
• ClinicalTrials.gov Identifier: NCT03971617
• Other Study ID Numbers: H2PD
• First Posted: June 3, 2019
• 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

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases