臨床研究等提出・公開システム

Date of registration	July. 09, 2020
Last modified on	Mar. 07, 2022
Trial ID	jRCT2080225269

Scientific Title	Late Phase II Study of TS-142 in Patients with Insomnia
Public Title	Late Phase II Study of TS-142 in Patients with Insomnia

Completion Date or Terminated date	Feb. 28, 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	Taisho Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@taisho.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Taisho Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@taisho.co.jp

Recruitment Status	completed

Date of First Enrolment		Sept. 09, 2020
Target Sample Size		160
Study Type		Interventional
Study Design	Study Design	randomized, parallel-group study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	To be eligible for study participation, an individual must meet all of the following criteria: -Japanese male and female age 20 years or older at the time of informed consent - Outpatients - Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder - Other protocol defined inclusion criteria could apply
	Exclusion Criteria	An individual who meets any of the following criteria will be excluded from participation in this study: - Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1 - Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1 - Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety - Other protocol defined exclusion criteria could apply
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Insomnia Disorder
Intervention(s)		investigational material(s) Generic name etc : TS-142 INN of investigational material : - Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : 2.5 mg, 5 mg or 10 mg once daily for 2 weeks control material(s) Generic name etc : placebo 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 Sujective sleep latency (sSL)
Secondary Outcome		efficacy Sujective sleep latency (sSL)

Primary Sponsor	Taisho Pharmaceutical Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Shintokai Yokohama Minoru Clinic Institutional Review Board
Address of IRB
Phone Number of IRB	+81-45-722-8655
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	July. 30, 2020

Secondary ID No.	NCT04469023
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-205365
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
5	Mar. 07, 2022	(this page)	Changes
4	Dec. 14, 2021	Detail	Changes
3	Sept. 14, 2020	Detail	Changes
2	Aug. 03, 2020	Detail	Changes
1	July. 10, 2020	Detail

List of change history