Unique ID issued by UMIN | UMIN000027825 |
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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 |
Open label, safty study of 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) to Duchenne muscular dystrophy
Open label study of 6MSITC to DMD
Open label, safty study of 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) to Duchenne muscular dystrophy
Open label study of 6MSITC to DMD
Japan |
Duchenne muscular dystrophy
Neurology |
Others
NO
Safty of 6-MSITC
Efficacy
Exploratory
Phase I
Urinary titin concentration
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
NO
No need to know
1
Treatment
Food |
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
13 | years-old | <= |
50 | years-old | >= |
Male
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.
DMD patient who has a severe complication
DMD patient who joined other clinical trials within 6 months
DMD patient who cannot swallow a capsule
6
1st name | |
Middle name | |
Last name | Hiroyuki Awano |
Kobe Graduate School of medicine
Department of Pediatrics
7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
078-382-6090
awahiro@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroyuki Awano |
Kobe Graduate School of medicine
Department of Pediatrics
7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
078-382-6090
awahiro@med.kobe-u.ac.jp
Department of Pediatrics,Kobe University Graduate School of Medicine
Kobe Wellness Science CO.,LTD
Other
The Faculty of Rehabilitation, Kobe Gakuin University
Laboratory of Molecular Life Science, Foundation for Biomedical Research and Innovation
NO
神戸大学医学部附属病院(兵庫県)
2017 | Year | 06 | Month | 19 | Day |
Unpublished
Completed
2016 | Year | 09 | Month | 26 | Day |
2016 | Year | 12 | Month | 01 | Day |
2018 | Year | 01 | Month | 25 | Day |
2018 | Year | 01 | Month | 31 | Day |
2017 | Year | 06 | Month | 19 | Day |
2018 | Year | 05 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027834
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