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Late Phase II Study of TS-142 in Patients with Insomnia

Late Phase II Study of TS-142 in Patients with Insomnia

179

Age (years): Mean+-SD 47.7+-11.7, Body Weight (kg): Mean+-SD 59.67+-11.47, Sex (%): Female 57.3, Duration of insomnia (years): 7.60+-8.03

179 subjects were randomized to any of the arms, and 178 of them received the investigational product once or more. 175 subjects completed, and 4 subjects discontinued the study.

The adverse events were observed in 8 of 45 subjects (17.8%) in Placebo group, 5 of 44 subjects (11.4%) in TS-142 2.5 mg group, 11 of 45 subjects (24.4%) in TS-142 5 mg group, 12 of 44 subjects (27.3%) in TS-142 10 mg group.

The primary endpoint, the sSL differences with placebo for the change from baseline at the end of the study, were shortened with dose increased and was significant in TS-142 10 mg group.

2.5 mg, 5 mg, and 10 mg of TS-142 shortened sSL based on sleep diary (primary endpoint) with dose increased and was significant in 10 mg group compared to placebo once daily before bedtime for 2 weeks in Japanese patients with insomnia disorder. No clinically relevant safety concerns were observed in TS-142 groups.

No

Taisho Pharmaceutical Co., Ltd.

clinical-trials@taisho.co.jp

Taisho Pharmaceutical Co., Ltd.

clinical-trials@taisho.co.jp

completed

Sept. 09, 2020

Interventional

randomized, parallel-group study

treatment purpose

2

To be eligible for study participation, an individual must meet all of the following criteria:

-Japanese male and female age 20 years or older at the time of informed consent
- Outpatients
- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder

- Other protocol defined inclusion criteria could apply

An individual who meets any of the following criteria will be excluded from participation
in this study:

- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1
- Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
- Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety

- Other protocol defined exclusion criteria could apply

Both

Insomnia Disorder

investigational material(s)
Generic name etc : TS-142
INN of investigational material : -
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for Investigational material : 2.5 mg, 5 mg or 10 mg once daily for 2 weeks

control material(s)
Generic name etc : placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

efficacy
Sujective sleep latency (sSL)

efficacy
Sujective sleep latency (sSL)

+81-45-722-8655

July. 30, 2020