Patients with Insomnia
Conditions
Brief summary
This is a randomized, open-label, multi-center long-term study in patients with insomnia.
Interventions
DRUGTS-142 10 mg
Participants received repeated doses of 10 mg of TS-142 (oral tablet)
DRUGTS-142 5 mg
Participants received repeated doses of 5 mg of TS-142 (oral tablet)
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 diseases other than depression and anxiety 3. Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | From start of investigational drug administration to final test and observation; up to approximately 1 year | To evaluate the Long-term safety of TS-142 in patients with insomnia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline of subjective sleep latency (sSL) | From baseline up to Week 52 | 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) | From baseline up to Week 52 | 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) | From baseline up to Week 52 | 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) | From baseline up to Week 52 | 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) | From baseline up to Week 52 | 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