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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000008959 |
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Date of registration:
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16/10/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy
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Scientific title:
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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 |
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Date of first enrolment:
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2012/11/01 |
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Target sample size:
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40 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010319 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase I
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Countries of recruitment
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Japan
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Contacts
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Name:
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Asako Yoritaka |
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Address:
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Hongo3-1-1, Bunkyo-ku, Tokyo
Japan |
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Telephone:
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Email:
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Affiliation:
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Juntendo University School of Medicine Juntendo Koshigaya Hospital Neurology |
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Name:
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Address:
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Hongo3-1-1, Bunkyo-ku, Tokyo
Japan |
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Telephone:
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Email:
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Affiliation:
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Juntendo University School of Medicine Neurology |
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Key inclusion & exclusion criteria
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Inclusion 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.
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Multiple system atrophy(MSA) Progressive supranuclear palsy (PSP)
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Intervention(s)
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hydrogen water
pseudo-water (nitrogen filling water)
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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Juntendo University School of Medicine, Department of Neurology
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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24/09/2015 |
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URL:
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