Patients with Insomnia
Conditions
Brief summary
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.
Interventions
DRUGTS-142 5 mg
Participants received repeated doses of 5 mg of TS-142 (oral tablet)
DRUGTS-142 10 mg
Participants received repeated doses of 10 mg of TS-142 (oral tablet)
DRUGPlacebo to TS-142
Participants received repeated doses of placebo to TS-142 (oral tablet)
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline | Baseline and Week 2 | sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline | 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 | 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 | 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 | 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 |
Countries
Japan
Outcome results
None listed