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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019195
Receipt No. 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

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Basic information
Public title A multicentre, long-term trial of KN01 in patients with MELAS
Acronym Long-term taurine-MELAS study
Scientific Title A multicentre, long-term trial of KN01 in patients with MELAS
Scientific Title:Acronym Long-term taurine-MELAS study
Region
Japan

Condition
Condition MELAS
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To confirm the long-term efficacy and safety of taurine supplementation therapy for prevention of stroke-like episodes in patients with MELAS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes (1)efficiency:annual relapsing rates of stroke-like episodes.
(2)safety:adverse events and advise effects
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 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
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 Patients agreed with the long-term taurine supplementation study, who priorly participated in the short -term one (UMIN000011908) .
Key exclusion criteria Same as the prior short-term study.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Sunada
Organization Kawasaki Medical School
Division name Neurology
Zip code
Address 577 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Email ysunada@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mai Moriyama
Organization CTD inc.
Division name Medical Prodiucts Promotion Division
Zip code
Address 3-3-2, Tsukiji, Chuo-ku, Tokyo,
TEL 03-6228-4105
Homepage URL https://www.c-ctd.co.jp/project_sn01/researcher/contents/documents.html
Email taurine@c-ctd.co.jp

Sponsor
Institute Kawasaki Medical School Hospital
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2015 Year 10 Month 08 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
2015 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 14 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
2015 Year 10 Month 01 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022183

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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