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

NCT03971617 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: H2PD
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Number of Treatment-emergent Adverse Events

  Number of treatment-emergent adverse events \[safety and tolerability\] of H2-enriched water in patients with Parkinson's disease (PD).

  56 weeks

Secondary Outcomes (4)

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

  56 weeks

• Score on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)

  56 weeks

• Score on the Montreal Cognitive Assessment (MoCA)

  56 weeks

• Score on the Combined Part I, Part II, Part III, and Part IV Subscales of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  56 weeks

Study Arms (2)

Hydrogen tablets

EXPERIMENTAL

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

Placebo tablets

PLACEBO COMPARATOR

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

Drug: Placebo oral tablet

Interventions

Hydrogen DRUG

each hydrogen tablet contains 80mg magnesium

Hydrogen tablets

Placebo oral tablet DRUG

matching placebo tablet

Placebo tablets

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Medical Center

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

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Hydrogen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Limitations and Caveats

Due to low enrollment in this study, we are not able to report on study outcome measures for participants and are unable to draw conclusions.

Results Point of Contact

• Title: Sandra Skinner
• Organization: Stony Brook University Medical Center

sandra.skinner@stonybrookmedicine.edu

631-444-7513

Study Officials

• Carine Maurer, MD,PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: May 29, 2019
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: April 12, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-04

Locations

US (1)