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

NCT ID: NCT03971617

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-29
• Study Completion Date: 2021-04-29

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hydrogen

Intervention Type: DRUG

each hydrogen tablet contains 80mg magnesium

Placebo tablets

effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

matching placebo tablet

Interventions

Hydrogen

each hydrogen tablet contains 80mg magnesium

Intervention Type: DRUG

Placebo oral tablet

matching placebo tablet

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Carine Maurer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carine Maurer, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University Medical Center

Stony Brook, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H2PD

Identifier Type: -

Identifier Source: org_study_id