Unique ID issued by UMIN | UMIN000008959 |
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Receipt number | R000010319 |
Scientific Title | Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy |
Date of disclosure of the study information | 2012/10/16 |
Last modified on | 2015/09/22 09:14:04 |
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
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
Japan |
Multiple system atrophy(MSA)
Progressive supranuclear palsy (PSP)
Neurology |
Others
NO
To determine that intake of molecular hydrogen water is safe and a disease-modifying treatment of MSA or PSP
Safety,Efficacy
Confirmatory
Phase I
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).
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.
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
YES
2
Treatment
Food |
hydrogen water
pseudo-water (nitrogen filling water)
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
40
1st name | |
Middle name | |
Last name | Asako Yoritaka |
Juntendo University School of Medicine
Juntendo Koshigaya Hospital
Neurology
Hongo3-1-1, Bunkyo-ku, Tokyo
1st name | |
Middle name | |
Last name |
Juntendo University School of Medicine
Neurology
Hongo3-1-1, Bunkyo-ku, Tokyo
Juntendo University School of Medicine, Department of Neurology
Juntendo University School of Medicine, Department of Neurology
Self funding
NO
順天堂大学附属順天堂医院 (東京)
2012 | Year | 10 | Month | 16 | Day |
Unpublished
Completed
2012 | Year | 10 | Month | 11 | Day |
2012 | Year | 11 | Month | 01 | Day |
2015 | Year | 09 | Month | 24 | Day |
2012 | Year | 09 | Month | 22 | Day |
2015 | Year | 09 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010319
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