臨床研究等提出・公開システム

Japanese

Date of registration	July. 09, 2022
Last modified on	Feb. 27, 2025
Trial ID	jRCT2031220209

Scientific Title	A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder.
Public Title	Phase III 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		Aug. 30, 2022
Target sample size		540
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel 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 disorders such as depression, schizophrenia, and anxiety 3. Patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder 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, TS-142 10 mg or TS-142 placebo once daily at night prior to bedtime]
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Subjective sleep latency (sSL) by sleep diary
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)	NCT05453136
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
10	Feb. 27, 2025	(this page)	Changes
9	May. 15, 2024	Detail	Changes
8	Dec. 24, 2023	Detail	Changes
7	Oct. 16, 2023	Detail	Changes
6	April. 16, 2023	Detail	Changes
5	Nov. 26, 2022	Detail	Changes
4	Oct. 22, 2022	Detail	Changes
3	Sept. 14, 2022	Detail	Changes
2	Aug. 18, 2022	Detail	Changes
1	July. 09, 2022	Detail

List of change history