臨床研究等提出・公開システム

Scientific Title	A Multi-center, Randomized, Open-label Long-Term Study of TS-142 in Patients with Insomnia Disorder
Public Title	Long-Term Study of TS-142 in Patients with Insomnia

Contact for Scientific Queries	Name	Seiji Mita
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	3-24,1, Takada, Toshima-Ku, Tokyo
	Telephone	+81-3-3985-1118
	E-mail	shu_chiken@taisho.co.jp
Contact for Public Queries	Name	Development Headquarters Development Management
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	3-24,1, Takada, Toshima-Ku, Tokyo
	Telephone	+81-3-3985-1118
	E-mail	shu_chiken@taisho.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		July. 20, 2022
Actual date of first enrollment		Oct. 11, 2022
Target sample size		300
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Japanese male and female who are aged 18 years or older at the time of informed consent 2. Outpatients 3. Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) Other protocol defined inclusion criteria could apply.
	Exclusion Criteria	1. Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5 2. Patients with psychiatric diseases other than depression and anxiety 3. Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep Other protocol defined exclusion criteria could apply.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Insomnia
Intervention(s)		Drug [TS-142(INN:vornorexant) 5 mg or TS-142 10 mg once a day at night prior to bedtime]
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Adverse Event
Secondary Outcome(s)

Primary Sponsor	Taisho Pharmaceutical Co., LTD.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation Shintokai Yokohama Minoru Clinic Institutional Review Board
Address	1-13-8, Bessho, Minami-Ku, Yokohama-City Kanagawa, Kanagawa
Telephone	+81-42-648-5551
E-Mail	yminoru-irb@eps.co.jp
Approval Status	Approval
Date of approval	July. 28, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05461352
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history