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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008959
Receipt No. 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

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Basic information
Public title Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy
Acronym Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in MSA and PSP
Scientific Title Trial of molecular hydrogen water in Multiple system atrophy and Progressive supranuclear palsy
Scientific Title:Acronym Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in MSA and PSP
Region
Japan

Condition
Condition Multiple system atrophy(MSA)
Progressive supranuclear palsy (PSP)
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine that intake of molecular hydrogen water is safe and a disease-modifying treatment of MSA or PSP
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes 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).
Key secondary outcomes 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.



Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 hydrogen water
Interventions/Control_2 pseudo-water (nitrogen filling water)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key 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.
Key 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Asako Yoritaka
Organization Juntendo University School of Medicine
Juntendo Koshigaya Hospital
Division name Neurology
Zip code
Address Hongo3-1-1, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University School of Medicine
Division name Neurology
Zip code
Address Hongo3-1-1, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Juntendo University School of Medicine, Department of Neurology
Institute
Department

Funding Source
Organization Juntendo University School of Medicine, Department of Neurology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 順天堂大学附属順天堂医院 (東京)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2015 Year 09 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 09 Month 22 Day
Last modified on
2015 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010319

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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