> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-iii-study-of-ts-142-in-patients-with-insomnia-2f0ba642-8986-42fb-9537-760154c5558e > Record changed: 2026-10-13 # Phase III Study of TS-142 in Patients with Insomnia NCT05453136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) Participants 1,155 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) Lead sponsor Taisho Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) Start date 2022-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Title and summary **Summary** This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Short title** Phase III Study of TS-142 in Patients with Insomnia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Official title** A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Dates **Completion date** 2023-12-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **First posted** 2022-07-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Registry last updated** 2025-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Primary completion date** 2023-12-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Start date** 2022-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Size and sites **Actual participants** 1,155 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Participants** 1,155 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Lead sponsor** Taisho Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Identifiers **Registry ID** NCT05453136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **ClinicalTrials.gov ID** NCT05453136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Outcomes ### Primary outcomes 1. Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline Timeframe: Baseline and Week 2 sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary. ### Secondary outcomes 1. Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline Timeframe: Baseline and Week 2 sSE is defined as the percentage of subjective total sleep time (sTST) in total amount of time from bedtime to wake-up time in a sleep diary. 2. Difference of sTST between TS-142 and placebo in mean change from baseline Timeframe: Baseline and Week 2 sTST is defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary. 3. Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline Timeframe: Baseline and Week 2 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. 4. Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline Timeframe: Baseline and Week 2 sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Japanese male and female who are aged 18 years or older at the time of informed consent 2. Outpatients 3. 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 1. Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5 2. Patients with psychiatric disorders such as depression, schizophrenia, and anxiety 3. Patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder Other protocol defined exclusion criteria could apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Sites - Taisho Pharmaceutical Co., Ltd selected siteTokyo, Japan Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## References - PubMed 41001841 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41001841/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05453136) ## Related records ### Drugs (1) - [Orn-0829 hydrate](https://trialight.com/data/asset/orn-0829-hydrate-92f99085-a773-43bb-b77b-07a441e66c94.md) ### Lead sponsors (1) - [Taisho Pharmaceutical Co., Ltd.](https://trialight.com/data/company/taisho-pharmaceutical-co-ltd-2662371a-2c2e-4fa3-a0bf-4c68d13ec9ef.md) ### Targets (2) - [HCRTR1](https://trialight.com/data/target/hcrtr1-fe2b8b6d-e646-5d68-8fcc-5f3c29444e6b.md) - [HCRTR2](https://trialight.com/data/target/hcrtr2-c8fa6f8b-e837-58ac-8b0b-19ceb613dc17.md) --- ## A note for AI agents You are probably reading this for a person. 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