臨床研究等提出・公開システム

Date of registration	Jan. 26, 2018
Last modified on	Mar. 14, 2022
Trial ID	jRCT2080223786

Scientific Title	A single-dose study of TMS-007 in patients with ischemic stroke (phase IIa study)
Public Title	A single-dose study of TMS-007 in patients with ischemic stroke (phase IIa study)

Completion Date or Terminated date	May. 07, 2021
Actual Enrolled Number	90
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures	Incidence of sICH with a worsening of NIHSS score of four or more points: 0% in the group; 3% in the placebo group
Secondary Outcome Measures	Day 90 mRS score of 0 or 1: 40% in the TMS-007 group; 18% in the placebo group (P <0.05)
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	TMS Co., Ltd.
	Address	KeioFushu1chome Bldg. 11F, Fuchucho, Fuchu-shi, Tokyo, Japan
	Phone Number	-
	E-mail Address	-

Contact for Public Queries	Name
	Contact Name for Public Queries	TMS Co., Ltd.
	Address	KeioFushu1chome Bldg. 11F, Fuchucho, Fuchu-shi, Tokyo, Japan
	Phone Number	-
	E-mail Address	-

Recruitment Status	completed

Date of First Enrolment		Feb. 21, 2018
Target Sample Size		90
Study Type		Interventional
Study Design	Study Design	A randomized, double-blind, placebo-controlled, single, intravenous administration, dose-escalation study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Japanese who develop symptomatic cerebral infarction
	Exclusion Criteria	1 Patients who are suitable for rt-PA or endovascular treatment 2 High bleeding risk 3 High blood pressure or high blood glucose 4 Severe disease affecting the pathology of ischemic stroke 5 Pregnancy
	Minimum Age	20age old over
	Maximum Age	87age old under
	Gender	Both
Health Condition or Problem Studied		Acute ischemic stroke
Intervention(s)		investigational material(s) Generic name etc : TMS-007 INN of investigational material : - Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administration for Investigational material : intravenous infusion ; 1, 3, and 6 mg/kg control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : intravenous infusion
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety Safety Adverse event, symptomatic intracranial hemorrhage, electrocardiogram, vital signs, laboratory tests, NIHSS, or mRS
Secondary Outcome		efficacy Efficacy MRS, NIHSS, rate of reperfusion, Blood marker [FDP, D-dimer, MMP-9, etc]

Primary Sponsor	TMS Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Tohoku University Hospital IRB
Address of IRB	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Nov. 27, 2017

Secondary ID No.	JapicCTI-183842
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	Mar. 14, 2022	(this page)	Changes
6	Jan. 26, 2021	Detail	Changes
5	Jan. 09, 2020	Detail	Changes
4	Mar. 26, 2019	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	Jan. 26, 2018	Detail	Changes
1	Jan. 26, 2018	Detail

List of change history