A Study to Evaluate the Safety and Efficacy of TS-091 in... | NCT03267303

Studies
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy

NCT03267303

Sponsor

Taisho Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Feb 28, 2025Actual

Enrollment

53Actual

Phase

Phase 2

Conditions

Narcolepsy

Interventions

TS-091 5mg
TS-091 10mg
Placebo

Countries

Japan
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
JapicCTI-173689	Other Identifier	JapicCTI

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2017Actual

Primary Completion Date

Dec 13, 2018Actual

Completion Date

Aug 8, 2019Actual

First Submitted Date

Aug 28, 2017

First Submission Date that Met QC Criteria

Aug 28, 2017

First Posted Date

Aug 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2025

Last Update Posted Date

Feb 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
TS-091 5mg	Experimental	Drug: TS-091 5mg
TS-091 10mg	Experimental	Drug: TS-091 10mg
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TS-091 5mg	Drug	Orally taken once daily for 3 weeks	TS-091 5mg
TS-091 10mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean sleep latency in maintenance of wakefulness test		3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Total score on the epworth sleepiness scale		3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria
Patients aged ≥16 to <65 years at the time of obtaining informed consent
Outpatients

Exclusion Criteria:

Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder)
Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy
Patients with obstructive respiratory diseases (bronchial asthma, emphysema)
Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

64 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shigeru Okuyama	Taisho Pharmaceutical Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taisho Pharmaceutical Co., Ltd selected site		Osaka and Other Japanese City			Japan
Taisho Pharmaceutical Co., Ltd selected site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35193545	Derived	Inoue Y, Uchiyama M, Umeuchi H, Onishi K, Ogo H, Kitajima I, Matsushita I, Nishino I, Uchimura N. Optimal dose determination of enerisant (TS-091) for patients with narcolepsy: two randomized, double-blind, placebo-controlled trials. BMC Psychiatry. 2022 Feb 22;22(1):141. doi: 10.1186/s12888-022-03785-7.

ID	Term
D006970	Disorders of Excessive Somnolence
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders