臨床研究等提出・公開システム

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder.

Phase III Study of TS-142 in Patients with Insomnia

596

Age (years): Mean+-SD 53.4+-12.8 (aged >=65 years:21.9%), Body Weight (kg): Mean+-SD 60.66+-12.57, Sex (%): Female 57.3, Duration of insomnia (years): 6.56+-7.31

A total of 596 patients were randomized to any of the arms. However, six of these patients were excluded from the analysis due to GCP violations, resulting in an allocation of 590 patients being included in the study. Among these 590 patients, 589 received the investigational product at least once. 583 patients completed the study, while 7 discontinued.

The adverse events were observed in 25 of 196 patients(12.8%)in Placebo group, 29 of 196 patients(14.8%)in TS-142 5 mg group, 32 of 197 patients (16.2%)in TS-142 10 mg group. No serious adverse events were observed.

As the primary endpoint, the change from baseline in sSL at week 2, measured with the sleep diary, was significantly greater in the 5 mg and 10 mg groups compared to the placebo group. As the key secondary endpoint, the change from baseline in sSE at week 2, measured by the sleep diary, was significantly greater in the 5 mg and 10 mg groups compared to the placebo group.

In this study, the Japanese patients with insomnia were administrated TS-142 5 mg or 10 mg once daily at bedtime for 2 weeks. As the primary and key secondary endpoints, the change from baseline in sSL and sSE were significantly greater in the 5 mg and 10 mg groups compared to the placebo group. Additionally, no major safety concerns were observed in TS-142 5 mg and 10 mg groups.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031220209

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

randomized controlled trial

double blind

placebo control

parallel 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 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 exclusion criteria could apply.

Both

insomnia

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

Subjective sleep latency (sSL) by sleep diary

+81-42-648-5551

July. 28, 2022

none