Clinical trial NCT03971617: Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Treatment-emergent Adverse Events
timeFrame: 56 weeks
Secondary outcomes:
measure: Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 56 weeks
measure: Score on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
timeFrame: 56 weeks
measure: Score on the Montreal Cognitive Assessment (MoCA)
timeFrame: 56 weeks
measure: 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)
timeFrame: 56 weeks
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
Study officials:
affiliation: Stony Brook University
name: Carine Maurer, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: