Unique ID issued by UMIN | UMIN000019195 |
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Receipt number | R000022183 |
Scientific Title | A multicentre, long-term trial of KN01 in patients with MELAS |
Date of disclosure of the study information | 2015/10/08 |
Last modified on | 2019/02/25 11:11:22 |
A multicentre, long-term trial of KN01 in patients with MELAS
Long-term taurine-MELAS study
A multicentre, long-term trial of KN01 in patients with MELAS
Long-term taurine-MELAS study
Japan |
MELAS
Neurology |
Others
YES
To confirm the long-term efficacy and safety of taurine supplementation therapy for prevention of stroke-like episodes in patients with MELAS
Safety,Efficacy
Confirmatory
Phase III
(1)efficiency:annual relapsing rates of stroke-like episodes.
(2)safety:adverse events and advise effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
taurine supplementation:
(1)duration:104 wks
(2)dose: 12 g (BW>40 kg), 9 g (BW:25-40 kg), 6 g (BW:15-25 kg), 3 g (BW<15 kg)
(3)times: TID
(4)frequency: daily
Not applicable |
Not applicable |
Male and Female
Patients agreed with the long-term taurine supplementation study, who priorly participated in the short -term one (UMIN000011908) .
Same as the prior short-term study.
9
1st name | |
Middle name | |
Last name | Yoshihide Sunada |
Kawasaki Medical School
Neurology
577 Matsushima, Kurashiki, Okayama
086-462-1111
ysunada@med.kawasaki-m.ac.jp
1st name | |
Middle name | |
Last name | Mai Moriyama |
CTD inc.
Medical Prodiucts Promotion Division
3-3-2, Tsukiji, Chuo-ku, Tokyo,
03-6228-4105
https://www.c-ctd.co.jp/project_sn01/researcher/contents/documents.html
taurine@c-ctd.co.jp
Kawasaki Medical School Hospital
AMED
Japanese Governmental office
NO
2015 | Year | 10 | Month | 08 | Day |
Unpublished
Completed
2015 | Year | 08 | Month | 10 | Day |
2015 | Year | 09 | Month | 14 | Day |
2015 | Year | 10 | Month | 01 | Day |
2019 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022183
Research Plan | |
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Registered date | File name |
Research case data | |
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