臨床研究等提出・公開システム

Date of registration	Sept. 18, 2019
Last modified on	Sept. 22, 2022
Trial ID	jRCT2080224879

Scientific Title	A Phase 2, Double-blind Study of S-005151 in Patients with Acute Ischemic Stroke
Public Title	A Phase 2, Double-blind Study of S-005151 in Patients with Acute Ischemic Stroke

Completion Date or Terminated date	Jan. 31, 2022
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
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	Shionogi & Co., Ltd.
	Address
	Phone Number	+81-6-6209-7885
	E-mail Address	shionogiclintrials-admin@shionogi.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Shionogi & Co., Ltd.
	Address
	Phone Number	+81-6-6209-7885
	E-mail Address	shionogiclintrials-admin@shionogi.co.jp

Recruitment Status	completed

Date of First Enrolment		Nov. 04, 2019
Target Sample Size		150
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, double-blind, placebo-controlled, parallel-group
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Main Inclusion Criteria - Patients diagnosed with supratentorial ischemic stroke on magnetic resonance imaging (MRI) - Patients who can be enrolled within 24 hours from 4.5 hours after the onset of ischemic stroke - Patients with neurologic signs corresponding to 8-22 on the National Institute of Health Stroke Scale (NIHSS) score and who have not experienced a rapid change in neurologic signs within 30 minutes before enrollment etc
	Exclusion Criteria	Main Exclusion Criteria - Patients with a disability corresponding to mRS score of >=2 before the onset of ischemic stroke - Patients who have undergone thrombolysis or intravascular recanalization therapy within 90 days before obtaining informed consent. - Patients with a history of stroke or intracranial hemorrhage that caused neurological events within 90 days before obtaining informed consent. - Patients diagnosed with a transient ischemic attack - Patients who cannot have MRI etc
	Minimum Age	60age old over
	Maximum Age	84age old under
	Gender	Both
Health Condition or Problem Studied		Acute Ischemic Stroke
Intervention(s)		investigational material(s) Generic name etc : S-005151 INN of investigational material : Redasemtide Therapeutic category code : 49- Other agents affecting cellular function Dosage and Administration for Investigational material : Intravenous injection control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy mRS 90 days after the first dose
Secondary Outcome		safety efficacy Main Secondary Outcome Safety - Adverse events, vital signs (blood pressure, pulse rate, body temperature, respiratory rate), electrocardiogram, clinical laboratory tests Efficacy - mRS at each visit other than day 90 - Proportion of subjects with mRS of <=1, <=2, and 5 or 6 at each visit etc

Primary Sponsor	SHIONOGI & CO., LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Institutional Review Board of Kyushu Hospital
Address of IRB	1-8-1, Yahata-Nishi-ku, Kitakyushu-shi, Fukuoka 806-8501
Phone Number of IRB	+81-93-641-5111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 19, 2019

Secondary ID No.	JapicCTI-194963
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	Sept. 22, 2022	(this page)	Changes
5	Sept. 10, 2021	Detail	Changes
4	Oct. 15, 2020	Detail	Changes
3	Oct. 15, 2020	Detail	Changes
2	Nov. 06, 2019	Detail	Changes
1	Sept. 19, 2019	Detail

List of change history