A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients with Narcolepsy
2 other identifiers
interventional
53
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2019
CompletedFebruary 28, 2025
October 1, 2019
1.1 years
August 28, 2017
February 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean sleep latency in maintenance of wakefulness test
3 weeks
Secondary Outcomes (1)
Total score on the epworth sleepiness scale
3 weeks
Study Arms (3)
TS-091 5mg
EXPERIMENTALTS-091 10mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Taisho Pharmaceutical Co., Ltd selected site
Osaka and Other Japanese City, Japan
Taisho Pharmaceutical Co., Ltd selected site
Seoul and Other Korean City, South Korea
Related Publications (1)
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.
PMID: 35193545DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shigeru Okuyama
Taisho Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2017
First Posted
August 30, 2017
Study Start
October 31, 2017
Primary Completion
December 13, 2018
Study Completion
August 8, 2019
Last Updated
February 28, 2025
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share