臨床研究等提出・公開システム

Date of registration	May. 07, 2014
Last modified on	Aug. 02, 2021
Trial ID	jRCT2080222479

Scientific Title	Phase2 Study of TS-091 in Patients With Narcolepsy
Public Title	Phase2 Study of TS-091 in Patients With Narcolepsy

Completion Date or Terminated date	April. 06, 2016
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		June. 14, 2014
Target Sample Size		45
Study Type		Interventional
Study Design	Study Design	Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-controlled Study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	- Outpatients - Patients diagnosed with narcolepsy 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 : - 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		safety efficacy(clinical condition etc)

Primary Sponsor	Taisho Pharmaceutical co., LTD
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Hannan Hospital IRB
Address of IRB
Phone Number of IRB	+81-72-278-0381
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	April. 18, 2014

Secondary ID No.	JapicCTI-142529
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
12	Aug. 02, 2021	(this page)	Changes
11	Dec. 17, 2018	Detail	Changes
10	July. 28, 2016	Detail	Changes
9	July. 28, 2016	Detail	Changes
8	Oct. 01, 2015	Detail	Changes
7	Oct. 01, 2015	Detail	Changes
6	June. 01, 2015	Detail	Changes
5	June. 01, 2015	Detail	Changes
4	Jan. 13, 2015	Detail	Changes
3	Jan. 13, 2015	Detail	Changes
2	May. 07, 2014	Detail	Changes
1	May. 07, 2014	Detail

List of change history