臨床研究等提出・公開システム

Date of registration	Aug. 31, 2018
Last modified on	June. 24, 2023
Trial ID	jRCT2080224029

Scientific Title	Please refer to ClinicalTrials.gov : NCT02864953.
Public Title	Please refer to ClinicalTrials.gov : NCT02864953.

Contact for Scientific Queries	Name	Toda Yasuo
	Contact Name for Scientific Queries	Biogen Japan Ltd.
	Address	Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027
	Phone Number	+81-120-560-086
	E-mail Address	japan-medinfo@biogen.com

Contact for Public Queries	Name	Biogen Japan Medical Information
	Contact Name for Public Queries	Biogen Japan Ltd.
	Address	Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027
	Phone Number	+81-120-560-086
	E-mail Address	japan-medinfo@biogen.com

Recruitment Status	terminated

Date of First Enrolment		Mar. 29, 2019
Target Sample Size		768
Study Type		Interventional
Study Design	Study Design	randmized controlled trial, multicenter, placebo control, double blind
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Please refer to ClinicalTrials.gov : NCT02864953.
	Exclusion Criteria	Please refer to ClinicalTrials.gov : NCT02864953.
	Minimum Age	18age old over
	Maximum Age	85age old under
	Gender	Both
Health Condition or Problem Studied		Large Hemispheric Infarction
Intervention(s)		investigational material(s) Generic name etc : INN of investigational material : Glibenclamide Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : control material(s) Generic name etc : INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material :
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy
Secondary Outcome		safety efficacy

Primary Sponsor	Biogen Japan Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB	Southern Tohoku General Hospital Institutional Review Board
Address of IRB	7-115 Yatsuyamada, Koriyama-shi, Fukushima
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	July. 20, 2018

Secondary ID No.	NCT02864953
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-184088
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/South America/Europe/Oceania

History of Changes

No	Publication date
5	June. 24, 2023	(this page)	Changes
4	Mar. 11, 2022	Detail	Changes
3	Mar. 15, 2021	Detail	Changes
2	April. 01, 2019	Detail	Changes
1	Aug. 31, 2018	Detail

List of change history