UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027825 |
|---|---|
| Receipt number | R000027834 |
| Scientific Title | Open label, safty study of 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) to Duchenne muscular dystrophy |
| Date of disclosure of the study information | 2017/06/19 |
| Last modified on | 2018/05/31 01:20:08 |
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Basic information
Public title
Open label, safty study of 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) to Duchenne muscular dystrophy
Acronym
Open label study of 6MSITC to DMD
Scientific Title
Open label, safty study of 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) to Duchenne muscular dystrophy
Scientific Title:Acronym
Open label study of 6MSITC to DMD
Region
| Japan |
Condition
Condition
Duchenne muscular dystrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safty of 6-MSITC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Urinary titin concentration
Key secondary outcomes
Serum CK level
Serum AST,ALT,BUN and Cr
WBC,Hb,Pltand PT-INR
Urine examination, Urinary NAG, Urinary beta2MG and Urinary Protein to Cr ratio.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
6-methylsulfinylhexyl Isothiocyanate; 6-MSITC
Oral administraion, 3 times a day
3mg/day for 4 weeks
Washout period for 4 weeks
9mg/day for 4weeks
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
| 13 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
A patient with Duchenne muscular dystrophy confirmed by genetic test and/or immunohistological findings in muscle biopsy
DMD patient who is taking a steroid therapy with consistent dose.
Key exclusion criteria
DMD patient who has a severe complication
DMD patient who joined other clinical trials within 6 months
DMD patient who cannot swallow a capsule
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Awano |
Organization
Kobe Graduate School of medicine
Division name
Department of Pediatrics
Zip code
Address
7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6090
awahiro@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Awano |
Organization
Kobe Graduate School of medicine
Division name
Department of Pediatrics
Zip code
Address
7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6090
Homepage URL
awahiro@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics,Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe Wellness Science CO.,LTD
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Faculty of Rehabilitation, Kobe Gakuin University
Laboratory of Molecular Life Science, Foundation for Biomedical Research and Innovation
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
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 19 | 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
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 01 | Month | 25 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027834
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
