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

Sponsor

Stony Brook University (Other)

Overall Status

Terminated

CT.gov ID

NCT03971617

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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

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 :

Apr 29, 2021

Actual Study Completion Date :

Apr 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

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

To determine the incidence of treatment-emergent adverse events [safety and tolerability] of H2-enriched water in patients with Parkinson's disease (PD). [56 weeks]
Incidence of treatment-emergent adverse events will be assessed

Secondary Outcome Measures

Score on the Part III subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [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) [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 [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 [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

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carine Maurer, Assistant Professor, Stony Brook University

ClinicalTrials.gov Identifier:

NCT03971617

Other Study ID Numbers:

H2PD

First Posted:

Jun 3, 2019

Last Update Posted:

May 10, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of May 10, 2021