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

Patients With Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469023
• Other study ID #: TS142-203
• Status: Completed
• Phase: Phase 2
• Start date: September 9, 2020
• Est. completion date: November 16, 2021

Study information

• Verified date: December 2021
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: November 16, 2021
• Est. primary completion date: November 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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 exclusion criteria could apply

Related Conditions & MeSH terms

• Patients With Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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