Late Phase II Study of TS-142 in Patients with Insomnia
1 other identifier
interventional
179
1 country
1
Brief Summary
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group exploratory study in patients with insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2020
Shorter than P25 for phase_2
1 active site
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
July 8, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedStudy Start
First participant enrolled
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2021
CompletedFebruary 28, 2025
December 1, 2021
1.2 years
July 8, 2020
February 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
LS mean difference from placebo; Change between baseline and end of the study of sSL
sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary
Baseline and Week 2
Secondary Outcomes (2)
LS mean difference from placebo; Change between baseline and end of the study of sTST
Baseline and Week 2
LS mean difference from placebo; Change between baseline and end of the study of sWASO
Baseline and Week 2
Study Arms (4)
TS-142 2.5 mg
EXPERIMENTALPeriod in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime
TS-142 5 mg
EXPERIMENTALPeriod in which participants received multiple-dose of 5 mg TS-142 prior to bedtime
TS-142 10 mg
EXPERIMENTALPeriod in which participants received multiple-dose of 10 mg TS-142 prior to bedtime
Placebo
EXPERIMENTALPeriod in which participants received single placebo prior to bedtime
Interventions
Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
Eligibility Criteria
You may qualify if:
- Japanese male and female age 20 years or older at the time of informed consent
- Outpatients
- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder
You may not qualify if:
- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1
- Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
- Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Taisho Director
Taisho Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2020
First Posted
July 13, 2020
Study Start
September 9, 2020
Primary Completion
November 16, 2021
Study Completion
November 16, 2021
Last Updated
February 28, 2025
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share