Phase III Study of TS-142 in Patients with Insomnia
- Summary
- This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.
- Short title
- Phase III Study of TS-142 in Patients with Insomnia
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder.
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2023-12-05
- First posted
- 2022-07-12
- Registry last updated
- 2025-02-28
- Primary completion date
- 2023-12-05
- Start date
- 2022-08-30
- Actual participants
- 1,155
- Participants
- 1,155
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05453136
- ClinicalTrials.gov ID
- NCT05453136
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masked roles
- Participants, Care providers, Investigators
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.
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.
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.
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.
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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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 disorders such as depression, schizophrenia, and anxiety
- 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.
- Taisho Pharmaceutical Co., Ltd selected siteTokyo, Japan
- PubMed 41001841Related publication