Late Phase II Study of TS-142 in Patients with Insomnia
NCT ID: NCT04469023
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
179 participants
INTERVENTIONAL
2020-09-09
2021-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TS-142 2.5 mg
Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime
TS-142
Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
TS-142 5 mg
Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime
TS-142
Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
TS-142 10 mg
Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime
TS-142
Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
Placebo
Period in which participants received single placebo prior to bedtime
TS-142
Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
Interventions
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TS-142
Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
Eligibility Criteria
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Inclusion Criteria
* Outpatients
* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder
Exclusion Criteria
* Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
* Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety
20 Years
ALL
No
Sponsors
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Taisho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Taisho Director
Role: STUDY_DIRECTOR
Taisho Pharmaceutical Co., Ltd.
Locations
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Taisho Pharmaceutical Co., Ltd selected site
Tokyo, , Japan
Countries
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Other Identifiers
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TS142-203
Identifier Type: -
Identifier Source: org_study_id
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