A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects

Summary

This is a study to investigate the next-day residual effects of a single bedtime dosing of 5 mg and 10 mg of TS-142 in Japanese healthy elderly participants in double-blind manner.

Timeline

Start

2023-05-15

Primary completion

2023-08-25

Completion

2023-08-25

Outcome

Met primary endpoint

paper The primary endpoint, area of body sway with eyes open (calculated using the root mean square of the center of pressure), was significantly smaller PMID 42174196 ↗

paper was significantly smaller in the vornorexant 5 mg and 10 mg groups compared to zopiclone (p=0.001 and 0.003, respectively) PMID 42174196 ↗

Publications

• Miyazaki Y, Kambe D, Imadera Y, Yamasaki H, Uchimura N, Uchiyama M. Comparison of next-morning residual effects by bedtime administration of vornorexant and zopiclone in healthy older participants: postural stability, neuropsychological functions, and subjective sleepiness in a randomized clinical study. Psychopharmacology (Berl). 2026 May 23. doi: 10.1007/s00213-026-07095-8. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TS-142	Small molecule	5 mg	—
Subject	TS-142	Small molecule	10 mg	—
Subject	Zopiclone	Small molecule	7.5 mg	—

Indications

No indication recorded.