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A Multi-center, Randomized, Open-label Long-Term Study of TS-142 in Patients with Insomnia Disorder

Long-Term Study of TS-142 in Patients with Insomnia

371

Age (years): Mean+-SD 55.8+-13.2 (aged >=65 years:33.0%), Body Weight (kg): Mean+-SD 60.78+-12.55, Sex (%): Female 55.0, Duration of insomnia (years): 7.17+-8.15

A total of 371 patients were randomized to either arm. However, four of these patients were excluded from the analysis due to GCP violations, resulting in an allocation of 367 patients being included in the study. All of these 367 patients received the investigational product at least once. A total of 321 patients completed the study, while 46 discontinued.

The adverse events were observed in 93 of 184 patients (50.5%) in TS-142 5 mg group, 95 of 183 patients (51.9%) in TS-142 10 mg group. Serious adverse events were observed 5 patients (2.7%) in TS-142 5 mg group and 2 patients (1.1%) in TS-142 10 mg group.

Efficacy endpoints, including sSL and sSE measured with the sleep diary, showed improvement over baseline at week 1. These effects were maintained throughout 52 weeks.

In this study, the Japanese patients with insomnia were administrated TS-142 5 mg or 10 mg once daily at bedtime for a long period. No major safety concerns were observed in TS-142 5 mg and 10 mg groups. Additionally, sSL and sSE, measured with the sleep diary, showed improvement from baseline and this effects were maintained.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031220208

Seiji Mita

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Development Headquarters Development Management

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

+81-3-3985-1118

shu_chiken@taisho.co.jp

Complete

July. 20, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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 exclusion criteria could apply.

Both

Insomnia

Drug [TS-142(INN:vornorexant) 5 mg or TS-142 10 mg once a day at night prior to bedtime]

Adverse Event

+81-42-648-5551

July. 28, 2022

none