UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicentre, long-term trial of KN01 in patients with MELAS
Title of the study (Brief title)	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	Yoshihide Sunada
Organization	Kawasaki Medical School
Division name	Neurology
Address	577 Matsushima, Kurashiki, Okayama
TEL	086-462-1111
Email	ysunada@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Mai Moriyama
Organization	CTD inc.
Division name	Medical Prodiucts Promotion Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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