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

Stony Brook University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Placebo oral tablet; Drug: Hydrogen

Study type: Interventional

Funder types: Other

Identifiers

NCT03971617

H2PD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2 participants in 2 patient groups, including a placebo group

Hydrogen tablets

Experimental group

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.

Treatment:

Drug: Hydrogen

Placebo tablets

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral tablet