Late Phase II Study of TS-142 in Patients with Insomnia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04469023

Enrollment

179

Registered

2020-07-13

Start date

2020-09-09

Completion date

2021-11-16

Last updated

2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Insomnia

Brief summary

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

Interventions

DRUGTS-142

Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Japanese male and female age 20 years or older at the time of informed consent * Outpatients * Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder * Other protocol defined inclusion criteria could apply

Exclusion criteria

* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1 * Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1 * Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety * Other protocol defined

Design outcomes

Primary

Measure	Time frame	Description
LS mean difference from placebo; Change between baseline and end of the study of sSL	Baseline and Week 2	sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary

Secondary

Measure	Time frame	Description
LS mean difference from placebo; Change between baseline and end of the study of sTST	Baseline and Week 2	sTST is defined as the total amount of time spent asleep before getting-out from his/her bed for the day as recorded in a sleep diary
LS mean difference from placebo; Change between baseline and end of the study of sWASO	Baseline and Week 2	sWASO is defined as the total amount of time spent awake after falling asleep and before getting-out from bed for the day as recorded in a sleep diary.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026