Long-Term Study of TS-142 in Patients With Insomnia

Patients With Insomnia Clinical Trial

Official title:

A Multi-center, Open-label Long-Term Study of TS-142 in Patients With Insomnia Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461352
• Other study ID #: TS142-302
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2022
• Est. completion date: March 7, 2024

Study information

• Verified date: March 2024
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open-label, multi-center long-term study in patients with insomnia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: March 7, 2024
• Est. primary completion date: March 7, 2024
• 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 diseases other than depression and anxiety

3. Patients with symptoms such as pain, pruritus, frequent urination and asthma that seriously prevent their sleep

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)

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	Incidence of adverse events	To evaluate the Long-term safety of TS-142 in patients with insomnia	From start of investigational drug administration to final test and observation; up to approximately 1 year
Secondary	Mean change from baseline of subjective sleep latency (sSL)	sSL defined as the duration of time that it took to fall asleep as recorded in a sleep diary.	From baseline up to Week 52
Secondary	Mean change from baseline of subjective sleep efficacy (sSE)	sSE is defined as the percentage of total sleep time (TST) in total amount of time from bedtime to wake-up time in a sleep diary.	From baseline up to Week 52
Secondary	Mean change from baseline of subjective total sleep time (sTST)	sTST defined as the total amount of time spent asleep before wake-up time as recorded in a sleep diary.	From baseline up to Week 52
Secondary	Mean change from baseline of subjective wake time after sleep onset (sWASO)	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.	From baseline up to Week 52
Secondary	Mean change from baseline of subjective number of awakenings (sNAW)	sNAW is defined as the total number of awaking after falling asleep and before getting out of bed as recored in a sleep diary	From baseline up to Week 52