Phase III Study of TS-142 in Patients With Insomnia

Patients With Insomnia Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients With Insomnia Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05453136
• Other study ID #: TS142-301
• Status: Completed
• Phase: Phase 3
• Start date: August 30, 2022
• Est. completion date: December 5, 2023

Study information

• Verified date: September 2023
• 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 confirmatory study in patients with insomnia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1155
• Est. completion date: December 5, 2023
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Japanese male and female who are aged 18 years or older at the time of informed consent

2. Outpatients

3. Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)

Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

1. Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5

2. Patients with psychiatric disorders such as depression, schizophrenia, and anxiety

3. Patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder

Other protocol defined exclusion criteria could apply.

Related Conditions & MeSH terms

• Patients With Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• TS-142 5 mg
Participants received repeated doses of 5 mg of TS-142 (oral tablet)
• TS-142 10 mg
Participants received repeated doses of 10 mg of TS-142 (oral tablet)
• Placebo to TS-142
Participants received repeated doses of placebo to TS-142 (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	Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline	sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary.	Baseline and Week 2
Secondary	Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline	sSE is defined as the percentage of subjective total sleep time (sTST) in total amount of time from bedtime to wake-up time in a sleep diary.	Baseline and Week 2
Secondary	Difference of sTST between TS-142 and placebo in mean change from baseline	sTST is defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary.	Baseline and Week 2
Secondary	Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline	sWASO is defined as the total amount of time spent awake after falling asleep and before wake-up time as recorded in a sleep diary.	Baseline and Week 2
Secondary	Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline	sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary	Baseline and Week 2