UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008959 |
|---|---|
| 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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Neurology
Institute
Department
Personal name
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
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
Value
https://center6.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 |
