Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy

Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in MSA and PSP

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008959

Enrollment

Registered

2012-10-16

Start date

2012-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple system atrophy(MSA) Progressive supranuclear palsy (PSP)

Interventions

hydrogen water pseudo-water (nitrogen filling water)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed as multiple system atrophy(A group), and progressive supranuclear palsy (PSP) (B group). 1) No change on medication, levodopa, dopamin agonist, and other limited drugs for eight weeks. 2) Without dysphagia for liquid. Part I-2 of unified MSA rateing scale (UMSARS) is under 1, 13th of Japanese PSP rating scale (PSPRS-J) is under 1. 3) Without dementia (MMSE >= 25). 4) Outpatients are better than admitted patietns. 5) The subjects are over 20 years-old. 6) Written informed consent must be obtained.

Exclusion criteria

Exclusion criteria: 1) The patient with corticobasal degeneration, and other disease with parkisonism. 2) Dysphagia for liquid. Part I-2 of unified MSA rateing scale (UMSARS) is over 2, 13th of Japanese PSP rating scale (PSPRS-J) is over 2. 3) The presence of other serious disease. 4) The presence of malignant tumor. 5) The presence of adverce event caused with dopaminagonist. 6) Subjects which are inappropriate for the study according to our judgment.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change from baseline to 48th week in total score of part I, II, and IV of the unified MSA rating scale (MSARS) (A group), and total score of progressive supranuclear palsy ratong scale-Japanese (PSPRS-J).	—

Secondary

Measure	Time frame
Additional analysis 1.The change of MSARS part I, II, IV or each score (A group), and total score or each score of PSPRS from baseline to 8, 24, 48 weeks and post 8th weeks. 2. The duration to protocol ended because of addition of levodopa or other limited drugs and urinary catheterization due to urinary retention, pneumonia, or respiratory failure. Safety analysis 1) Adverse events. 2) Screening laboratory studies included level of total protein, albumin, alkaline phosphatase, aspartate transaminase, alanine transaminase, serum urea nitrogen, calcium, chloride, creatinine, glucose, lactate dehydrogenase, potassium, sodium, creatinine kinase, uric acid, choline esterase, LDL-cholestrol, HDL-cholestrol and triglyceride.	—

Measure

Time frame

Additional analysis 1.The change of MSARS part I, II, IV or each score (A group), and total score or each score of PSPRS from baseline to 8, 24, 48 weeks and post 8th weeks. 2. The duration to protocol ended because of addition of levodopa or other limited drugs and urinary catheterization due to urinary retention, pneumonia, or respiratory failure. Safety analysis 1) Adverse events. 2) Screening laboratory studies included level of total protein, albumin, alkaline phosphatase, aspartate transaminase, alanine transaminase, serum urea nitrogen, calcium, chloride, creatinine, glucose, lactate dehydrogenase, potassium, sodium, creatinine kinase, uric acid, choline esterase, LDL-cholestrol, HDL-cholestrol and triglyceride.

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026