UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005969 |
|---|---|
| Receipt number | R000007032 |
| Scientific Title | Clinical trial aimed at new therapeutic strategy for HAM by prosultiamine treatment with oral administration |
| Date of disclosure of the study information | 2011/07/15 |
| Last modified on | 2012/07/25 18:49:23 |
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Basic information
Public title
Clinical trial aimed at new therapeutic strategy for HAM by prosultiamine treatment with oral administration
Acronym
Oral prosultiamine treatment against HAM patients as new therapeutics
Scientific Title
Clinical trial aimed at new therapeutic strategy for HAM by prosultiamine treatment with oral administration
Scientific Title:Acronym
Oral prosultiamine treatment against HAM patients as new therapeutics
Region
| Japan |
Condition
Condition
HTLV-I associated myelopathy (HAM)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of the treatment aimed at targeting HTLV-I-infected cells by oral administration of prosultiamine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of neurological signs including motor disability score and urinary disturbance with the decrease of HTLV-I-infected cells in the peripheral blood at 12 weeks after commencement.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of prosultiamine at dosages of 300mg daily for 12 weeks
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HAM patients who fulfilled the criteria of WHO
Key exclusion criteria
HAM patients who do not approve the protocol
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsufumi Nakamura |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
The Department of Molecular Microbiology and Immunology
Zip code
Address
1-12-4 Sakamoto, Nagasaki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
The Department of Molecular Microbiology and Immunology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
The Department of Molecular Microbiology and Immunology
Institute
Department
Personal name
Funding Source
Organization
The Health and Labour Sciences Research Grant on Intractable Diseases
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 15 | 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
| 2011 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 13 | Day |
Last modified on
| 2012 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007032
