Back to resultsA Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy
Primary Purpose
Narcolepsy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TS-091 5mg
TS-091 10mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Narcolepsy focused on measuring Narcolepsy
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)
Sites / Locations
- Taisho Pharmaceutical Co., Ltd selected site
- Taisho Pharmaceutical Co., Ltd selected site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
TS-091 5mg
TS-091 10mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Mean sleep latency in maintenance of wakefulness test
Secondary Outcome Measures
Total score on the epworth sleepiness scale
Full Information
NCT ID
NCT03267303
First Posted
August 28, 2017
Last Updated
October 4, 2022
Sponsor
Taisho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03267303
Brief Title
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy
Official Title
A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients With Narcolepsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
August 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taisho Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy
Keywords
Narcolepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TS-091 5mg
Arm Type
Experimental
Arm Title
TS-091 10mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TS-091 5mg
Intervention Description
Orally taken once daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
TS-091 10mg
Intervention Description
Orally taken once daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally taken once daily for 3 weeks
Primary Outcome Measure Information:
Title
Mean sleep latency in maintenance of wakefulness test
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Total score on the epworth sleepiness scale
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Okuyama
Organizational Affiliation
Taisho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Taisho Pharmaceutical Co., Ltd selected site
City
Osaka And Other Japanese City
Country
Japan
Facility Name
Taisho Pharmaceutical Co., Ltd selected site
City
Seoul And Other Korean City
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
35193545
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy
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