Unique ID issued by UMIN | UMIN000033016 |
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Receipt number | R000037017 |
Scientific Title | Open label, efficacy and safety study of long-term 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) administration to Duchenne muscular dystrophy |
Date of disclosure of the study information | 2018/08/01 |
Last modified on | 2018/12/14 16:53:13 |
Open label, efficacy and safety study of long-term 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) administration to Duchenne muscular dystrophy
Long-term 6-MSITC administration to Duchenne muscular dystrophy
Open label, efficacy and safety study of long-term 6-methylsulfinylhexyl Isothiocyanate(6-MSITC) administration to Duchenne muscular dystrophy
Long-term 6-MSITC administration to Duchenne muscular dystrophy
Japan |
Duchenne muscular dystrophy
Pediatrics |
Others
NO
Efficacy of 6-MSITC
Safety
Exploratory
Phase I
Urinary titin concentration
Serum CK level, Urinary 8OhDG
Serum AST,ALT,BUN and Cr
WBC,Hb,Plt
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
9mg/day for 8 weeks
13 | years-old | <= |
Not applicable |
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
3
1st name | |
Middle name | |
Last name | Hiroyuki Awano |
Kobe University Graduate School of Medicine
Department of Pediatrics
7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
+81-78-382-6090
awahiro@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroyuki Awano |
Kobe University Graduate School of Medicine
Department of Pediatrics
7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
+81-78-382-6090
awahiro@med.kobe-u.ac.jp
Kobe University
Productive Aging Laboratory,CO., Ltd.
Other
The Faculty of Rehabilitation, Kobe Gakuin University
Laboratory of Molecular Life Science, Foundation for Biomedical Research and Innovation
NO
2018 | Year | 08 | Month | 01 | Day |
Unpublished
Terminated
2018 | Year | 04 | Month | 20 | Day |
2018 | Year | 08 | Month | 01 | Day |
2018 | Year | 06 | Month | 15 | Day |
2018 | Year | 12 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037017
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