臨床研究等提出・公開システム

Date of registration	Aug. 30, 2017
Last modified on	Mar. 24, 2022
Trial ID	jRCT2080223633

Scientific Title	A Phase 2, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients with Narcolepsy
Public Title	A Phase 2, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients with Narcolepsy

Completion Date or Terminated date	Aug. 08, 2019
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	Feb. 22, 2022
URL hyperlink(s) related to results and publications	https://bmcpsychiatry.biomedcentral.com/track/pdf/10.1186/s12888-022-03785-7.pdf

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		Oct. 31, 2017
Target Sample Size		48
Study Type		Interventional
Study Design	Study Design	A multicenter, randomized, placebo-controlled, double-blind, parallel-group comparative study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients diagnosed with narcolepsy - Outpatients etc.
	Exclusion Criteria	- Having other sleep disorders. - Having renal disease, severe liver disease, cardiovascular disease, hematologic disease and malignancy. etc.
	Minimum Age	16age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		narcolepsy
Intervention(s)		investigational material(s) Generic name etc : TS-091 INN of investigational material : enerisant Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Placebo INN of investigational material : Placebo Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy efficacy(daytime sleepiness)
Secondary Outcome		efficacy efficacy(clinical condition etc)

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

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB	ー
E-mail Address of IRB	ー
Status of IRB Review	approved
Date of Approval by IRB	Aug. 18, 2017

Secondary ID No.	NCT03267303
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173689
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan

History of Changes

No	Publication date
11	Mar. 24, 2022	(this page)	Changes
10	Oct. 11, 2019	Detail	Changes
9	Dec. 17, 2018	Detail	Changes
8	Feb. 22, 2018	Detail	Changes
7	Feb. 22, 2018	Detail	Changes
6	Nov. 30, 2017	Detail	Changes
5	Nov. 30, 2017	Detail	Changes
4	Sept. 01, 2017	Detail	Changes
3	Sept. 01, 2017	Detail	Changes
2	Aug. 30, 2017	Detail	Changes
1	Aug. 30, 2017	Detail

List of change history