Trial Outcomes & Findings for Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease (NCT NCT03971617)

Last Updated: 2023-04-12

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

2 participants

Primary outcome timeframe

56 weeks

Results posted on

2023-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	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. Hydrogen: each hydrogen tablet contains 80mg magnesium	Placebo Tablets effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water Placebo oral tablet: matching placebo tablet
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 56 weeks

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

Outcome measures

Outcome measures
Measure	Hydrogen Tablets n=1 Participants 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. Hydrogen: each hydrogen tablet contains 80mg magnesium	Placebo Tablets n=1 Participants effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water Placebo oral tablet: matching placebo tablet
Number of Treatment-emergent Adverse Events	0 Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: 56 weeks

Population: Note: Data cannot be reported due to privacy issues associated with low enrollment

Change from baseline to week 56 in motor examination, as assessed by score on Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part III of the MDS-UPDRS assesses the motor signs of Parkinson's Disease. Scores range from 0-33 with a lower score indicating less severe impairment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 56 weeks

Population: Note: results cannot be reported due to privacy issues associated with low enrollment

Change from baseline to week 56 in Parkinson's Disease-related quality of life as assessed by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39). The PDQ-39 assesses how often patients experience difficulties across 8 quality of life domains (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). Scores for each domain range from 0 to 100 with lower scores indicating more impaired quality of life. The overall score is an average of the scores for the 8 dimensions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 56 weeks

Population: Note: Data cannot be reported due to privacy issues associated with low enrollment

Change from baseline to week 56 in overall cognitive function as assessed by the Montreal Cognitive Assessment (MoCA) score. Scores on the MoCA range from 0-30 with lower scores indicating more cognitive impairment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 56 weeks

Population: Note: Data cannot be reported due to privacy issues associated with low enrollment

Change from baseline to week 56 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS consists of four sub-scales. For each sub-scale, lower scores indicate less severe impairment. The scales are: Part I, non-motor experiences of daily living (scores range from 0-52); Part II, motor experiences of daily living (scores range from 0-52); Part III, motor examination (scores range from 0-132) and part IV, motor complications (scores range from 0-24). Score for the total assessment ranges from 0 to 260 with lower scores indicating less severe impairment.

Outcome measures

Outcome data not reported

Adverse Events

Hydrogen Tablets

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Tablets

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sandra Skinner

Stony Brook University Medical Center

Phone: 631-444-7513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Hydrogen Tablets n=1 Participants 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. Hydrogen: each hydrogen tablet contains 80mg magnesium	Placebo Tablets n=1 Participants effervescent placebo tablets will also contain 80 mg magnesium but do not generate hydrogen-enriched water Placebo oral tablet: matching placebo tablet	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants