Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder

Summary

Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.

Timeline

Start

2017-07-07

Primary completion

2019-02-13

Completion

2019-02-13

Outcome

Met primary endpoint

paper in LPS with 5, 10, and 30 mg TS-142 were - 42.38 (- 60.13, - 24.63), - 42.10 (- 60.02, - 24.17), and - 44.68 (- 62.41, - 26.95) minutes, respectively (all p < 0.001). PMID 35296912 ↗

paper in WASO with 5, 10, and 30 mg TS-142 were - 27.52 (- 46.90, - 8.14), - 35.44 (- 55.02, - 15.87), and - 54.69 (- 74.16, - 35.23) minutes, respectively (all p < 0.01). PMID 35296912 ↗

Publications

• Uchiyama M, Kambe D, Imadera Y, Kajiyama Y, Ogo H, Uchimura N. Effects of TS-142, a novel dual orexin receptor antagonist, on sleep in patients with insomnia: a randomized, double-blind, placebo-controlled phase 2 study. Psychopharmacology (Berl). 2022 Jul;239(7):2143-2154. doi: 10.1007/s00213-022-06089-6. Epub 2022 Mar 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TS-142	Small molecule	5 mg	—
Subject	TS-142	Small molecule	10 mg	—
Subject	TS-142	Small molecule	30 mg	—

Indications