Insomnia Disorder
Conditions
Brief summary
Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.
Interventions
DRUGTS-142
Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Participants received single dose-matched placebo to TS-142 (oral capsule)
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients * Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1 * Other protocol defined inclusion criteria could apply
Exclusion criteria
* Patients with a history of any of the following diseases according to the DSM-5 criteria: 1. Hypersomnolence disorder 2. Narcolepsy 3. Breathing-related sleep disorders 4. Circadian rhythm sleep-wake disorder 5. Parasomnias 6. Restless legs syndrome 7. Substance/medication-induced sleep disorder * Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy * Patients with a history of poorly controlled diabetes mellitus (HbA1c \>8%) * Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (\>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder * Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LS mean difference of LPS from placebo | Day 1 | LPS is defined as the duration of time from the light off to the first persistent (10 consecutive minutes) sleep episode as measured by overnight PSG. |
| LS mean difference of WASO from placebo | Day 1 | WASO is defined as the time spent in wakefulness from the first persistent (10 consecutive minutes) sleep episode to the light on as measured by overnight PSG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LS mean difference of TST from placebo | Day 1 | TST is defined as the time spent in sleep from the light off to the light on as measured by overnight PSG. |
Countries
Japan
Outcome results
None listed