UMIN-CTR Clinical Trial

Basic information
Public title	Development of oral taurine therapy for the treatment of stroke-like epiodes of MELAS
Acronym	Taurine therapy for stroke-like epiodes of MELAS
Scientific Title	Development of oral taurine therapy for the treatment of stroke-like epiodes of MELAS
Scientific Title:Acronym	Taurine therapy for stroke-like epiodes of MELAS
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of taurine for the prevention of stroke-like episodes of MELAS
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Frequency of stroke-like episodes -Score of neurological disability -Degree of brain MRI lesions
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	Twelve patients with MELAS having A3243G and T3271C mutations in the mitochondrial DNA are enrolled in the study. Oral taurine (12 g/d>BW40 kg; 9 g/d:25-39 kg; 6 g/d:15-24 kg; 3 g/d<15 kg) is administered to the patients for 24 months to evaluate the efficacy of the prevention for stroke-like episodes.
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	Male and female patients
Key exclusion criteria	none
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yutaka Ohsawa
Organization	Kawasaki Medical School
Division name	Neurology
Zip code
Address	577 Matsushima, Kurashiki-city, Okayama 701-0192, Japan
TEL	086-462-1111
Email	yosawa@med.kawasaki-m.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Yutaka Ohsawa
Organization	Kawasaki Medical School
Division name	Neurology
Zip code
Address	577 Matsushima,Kurashiki-city, Okayama 701-0192, Japan
TEL	086-462-1111
Homepage URL	http://www.kawasaki-m.ac.jp/med/kenkyu/01.html
Email	yosawa@med.kawasaki-m.ac.jp

Sponsor
Institute	Department of Neurology, Kawasaki Medical School
Institute
Department

Funding Source
Organization	Department of Neurology, Kawasaki Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	School of Medicine, Juntendo University
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	川崎医科大学附属病院（岡山県）/Kawasaki Medical School Hospital 新潟大学医歯学総合病院（新潟県）/Niigata University Medical & Dental Hospital 名古屋第一赤十字病院（愛知県）/Japanese Red Cross Nagoya Daiichi Hospital 山形大学医学部附属病院（山形県）/Yamagata University Hospital

Other administrative information
Date of disclosure of the study information	2011 Year 05 Month 12 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	2011 Year 05 Month 09 Day
Date of IRB	2011 Year 04 Month 11 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 05 Month 12 Day
Last modified on	2019 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006614