UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015538 |
|---|---|
| Receipt number | R000017746 |
| Scientific Title | A multicentre, long-term administration study of KN01 in patients with mitochondrial encephalomyopathy(MELAS) |
| Date of disclosure of the study information | 2014/10/27 |
| Last modified on | 2019/02/25 11:10:53 |
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Basic information
Public title
A multicentre, long-term administration study of KN01 in patients with mitochondrial encephalomyopathy(MELAS)
Acronym
MELAS-taurine long-term study
Scientific Title
A multicentre, long-term administration study of KN01 in patients with mitochondrial encephalomyopathy(MELAS)
Scientific Title:Acronym
MELAS-taurine long-term study
Region
| Japan |
Condition
Condition
motochondrial encephalomyopathy (MELAS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the safety of long-term taurine supplementation therapy for prevention of stroke-like episodes in patients with MELAS
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
safety: adverse events and adverse 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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
taurine supplementation
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
(1)MELAS patients who participated in the multiceentre trial of KN01 (KN01-MELAS-01:UMIN000011908).
(2)Adult patients who agree to participate in the clinical trial and sign the written informed consent document. Children patients who cannot autonomously provide informed consent are required to give informed assent by themselves. Instead, their parents sign the written informed consent document.
Key exclusion criteria
(1) Patients can not be conducted by head MRI scan because of pacemaker implantation, etc.
(2) Patients with severe coma or status epileptics
(3) Patients incapable of communication due to dementia, bedridden, etc.,
(4) Patients with merger sepsis
(5) Patients with severe impairment in cardiac, liver, or renal function
(6) Patients in need of systemic administration of steroids for a long period of time (2 weeks or more)
(7) Patients with pyruvate in 12 weeks before obtaining informed consent
(8) Patients who are pregnant or lactating, or may be pregnant
(9) Patients with history of hypersensitivity to the component of study drug
(10)Ppatients with history of drug allergy
(11) Patients who participated in clinical trials within 12 weeks before obtaining informed consent
(12) Other, patients whom physician or investigator has determined disqualified as participants
Target sample size
10
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-city,Okayama 701-0192 Japan
TEL
086-462-1111
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
Medicinal Products 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
taurine@c-ctd.co.jp
Sponsor or person
Institute
Kawasaki Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Defense Medical College Hospital
Seirei Hamamatsu General Hospital
Fujita Health University School of Medicine
National Hospital Organization Kyoto Medical Center
Hyogo-Chuo National Hospital
Fukuoka University Chikushi Hospital
Nagasaki University Hospital
Hiroshima University Hospital
Nippon Medical School
National Center of Neurology and Psychiatry
Teikyo University of Science
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
9月8日
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 27 | 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
| 2014 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 02 | 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
| 2014 | Year | 10 | Month | 27 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017746
