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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004478
Receipt No. R000005359
Scientific Title Clinical trial aimed at a complete cure of HAM by prosultiamine treatment with oral administration
Date of disclosure of the study information 2010/11/01
Last modified on 2012/05/25

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Basic information
Public title Clinical trial aimed at a complete cure of HAM by prosultiamine treatment with oral administration
Acronym Oral prosultiamine treatment against HAM patients
Scientific Title Clinical trial aimed at a complete cure of HAM by prosultiamine treatment with oral administration
Scientific Title:Acronym Oral prosultiamine treatment against HAM patients
Region
Japan

Condition
Condition HTLV-I associated myelopathy (HAM)
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The ideal treament against HAM patients is the elimination of HTLV-I-infected cells from body. The purpose of this clinical trial is 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 the decrease of HTLV-I-infected cells in the peripheral blood at 4 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 4 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 10

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
Email

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
Email

Sponsor
Institute The Department of Molecular Microbiology and Immunology
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 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
2010 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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
2010 Year 10 Month 29 Day
Last modified on
2012 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005359

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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