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drugset / Trial / NCT05453136

Phase III Study of TS-142 in Patients with Insomnia

NCT05453136 ↗

Phase 3 Completed 1155 enrolled Taisho Pharmaceutical Co., Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.

Timeline

Start: 2022-08-30
Primary completion: 2023-12-05
Completion: 2023-12-05

Publications

Uchiyama M, Kambe D, Hasegawa S, Imadera Y, Yamasaki H, Uchimura N. Efficacy and safety of vornorexant in Japanese patients with insomnia: a randomized, placebo-controlled phase 3 pivotal study. Sleep. 2026 Mar 11;49(3):zsaf291. doi: 10.1093/sleep/zsaf291.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TS-142	Small molecule	5 mg	Oral
Subject	TS-142	Small molecule	10 mg	Oral

Indications