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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 April 2023
• Main ID: NCT03971617
• Date of registration: 30/05/2019
• Prospective Registration: No
• Primary sponsor: Stony Brook University
• Public title: Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
• Scientific title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease
• Date of first enrolment: May 29, 2019
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03971617
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Carine Maurer, MD,PhD
• Affiliation: Stony Brook University

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Hydrogen

Drug: Placebo oral tablet

Primary Outcome(s)

Number of Treatment-emergent Adverse Events [Time Frame: 56 weeks]

Secondary Outcome(s)

Score on the Parkinson's Disease Quality of Life Questionnaire (PDQ-39) [Time Frame: 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) [Time Frame: 56 weeks]

Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time Frame: 56 weeks]

Score on the Montreal Cognitive Assessment (MoCA) [Time Frame: 56 weeks]

Secondary ID(s)

H2PD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/04/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03971617