Back to resultsLong-Term Study of TS-142 in Patients With Insomnia
Primary Purpose
Patients With Insomnia
Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TS-142 5 mg
TS-142 10 mg
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Insomnia
Eligibility Criteria
Inclusion Criteria:
- Japanese male and female who are aged 18 years or older at the time of informed consent
- Outpatients
- Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
- Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
- Patients with psychiatric diseases other than depression and anxiety
- Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep
Other protocol defined exclusion criteria could apply.
Sites / Locations
- Taisho Pharmaceutical Co., Ltd selected site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
5 mg
10 mg
Arm Description
Period in which participants received repeated doses of 5 mg TS-142 prior to bedtime
Period in which participants received repeated doses of 10 mg TS-142 prior to bedtime
Outcomes
Primary Outcome Measures
Incidence of adverse events
To evaluate the Long-term safety of TS-142 in patients with insomnia
Secondary Outcome Measures
Mean change from baseline of subjective sleep latency (sSL)
sSL defined as the duration of time that it took to fall asleep as recorded in a sleep diary.
Mean change from baseline of subjective sleep efficacy (sSE)
sSE is defined as the percentage of total sleep time (TST) in total amount of time from bedtime to wake-up time in a sleep diary.
Mean change from baseline of subjective total sleep time (sTST)
sTST defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary.
Mean change from baseline of subjective wake time after sleep onset (sWASO)
sWASO is defined as the total amount of time spent awake after falling asleep and before wake-up time as recorded in a sleep diary.
Mean change from baseline of subjective number of awakenings (sNAW)
sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary
Full Information
NCT ID
NCT05461352
First Posted
July 7, 2022
Last Updated
September 1, 2023
Sponsor
Taisho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05461352
Brief Title
Long-Term Study of TS-142 in Patients With Insomnia
Official Title
A Multi-center, Open-label Long-Term Study of TS-142 in Patients With Insomnia Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
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
5. Study Description
Brief Summary
This is a randomized, open-label, multi-center long-term study in patients with insomnia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
401 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5 mg
Arm Type
Experimental
Arm Description
Period in which participants received repeated doses of 5 mg TS-142 prior to bedtime
Arm Title
10 mg
Arm Type
Experimental
Arm Description
Period in which participants received repeated doses of 10 mg TS-142 prior to bedtime
Intervention Type
Drug
Intervention Name(s)
TS-142 5 mg
Intervention Description
Participants received repeated doses of 5 mg of TS-142 (oral tablet)
Intervention Type
Drug
Intervention Name(s)
TS-142 10 mg
Intervention Description
Participants received repeated doses of 10 mg of TS-142 (oral tablet)
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
To evaluate the Long-term safety of TS-142 in patients with insomnia
Time Frame
From start of investigational drug administration to final test and observation; up to approximately 1 year
Secondary Outcome Measure Information:
Title
Mean change from baseline of subjective sleep latency (sSL)
Description
sSL defined as the duration of time that it took to fall asleep as recorded in a sleep diary.
Time Frame
From baseline up to Week 52
Title
Mean change from baseline of subjective sleep efficacy (sSE)
Description
sSE is defined as the percentage of total sleep time (TST) in total amount of time from bedtime to wake-up time in a sleep diary.
Time Frame
From baseline up to Week 52
Title
Mean change from baseline of subjective total sleep time (sTST)
Description
sTST defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary.
Time Frame
From baseline up to Week 52
Title
Mean change from baseline of subjective wake time after sleep onset (sWASO)
Description
sWASO is defined as the total amount of time spent awake after falling asleep and before wake-up time as recorded in a sleep diary.
Time Frame
From baseline up to Week 52
Title
Mean change from baseline of subjective number of awakenings (sNAW)
Description
sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary
Time Frame
From baseline up to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Japanese male and female who are aged 18 years or older at the time of informed consent
Outpatients
Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
Patients with psychiatric diseases other than depression and anxiety
Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep
Other protocol defined exclusion criteria could apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taisho Director
Organizational Affiliation
Taisho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Taisho Pharmaceutical Co., Ltd selected site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Long-Term Study of TS-142 in Patients With Insomnia
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