Patients with InsomniaPhase 3NCT05453136
Phase III Study of TS-142 in Patients with Insomnia
A Phase 3 study testing TS-142 5 mg and TS-142 10 mg in people with Patients with Insomnia, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients with Insomnia
- What is being tested?
- TS-142 5 mg and TS-142 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,155 participants
- Where
- 1 siteJapan
- Study dates
- 30 Aug 2022to 5 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese male and female who are aged 18 years or older at the time of informed consent
- Outpatients
- 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.
Who cannot join
- Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
- Patients with psychiatric disorders such as depression, schizophrenia, and anxiety
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder.
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.
- Conditions
- Patients with Insomnia
- Being tested
- TS-142 5 mg, TS-142 10 mg, Placebo to TS-142
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-142 5 mgDrug
Participants received repeated doses of 5 mg of TS-142 (oral tablet)
TS-142 10 mgDrug
Participants received repeated doses of 10 mg of TS-142 (oral tablet)
Placebo to TS-142Drug
Participants received repeated doses of placebo to TS-142 (oral tablet)
| Study group | Role | What they receive |
|---|---|---|
| 5 mg | Experimental | Period in which participants received repeated doses of 5 mg TS-142 prior to bedtime Receives: Drug: TS-142 5 mg |
| 10 mg | Experimental | Period in which participants received repeated doses of 10 mg TS-142 prior to bedtime Receives: Drug: TS-142 10 mg |
| Placebo | Placebo comparator | Period in which participants received repeated doses of placebo prior to bedtime Receives: Drug: Placebo to TS-142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 2
Secondary outcomes (4)
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.
Measured: Baseline and Week 2
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.
Measured: Baseline and Week 2
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.
Measured: Baseline and Week 2
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
Measured: Baseline and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start30 Aug 2022
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients with InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453136
- Sponsor's protocol ID
- TS142-301
- Status last verified
- Sep 2023
- First submitted
- 7 Jul 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uchiyama M, Kambe D, Hasegawa S, Imadera Y, Yamasaki H, Uchimura N. Efficacy and safety of vornorexant in Japanese patients with insomnia: a randomized, placebo-controlled phase 3 pivotal study. Sleep. 2026 Mar 11;49(3):zsaf291. doi: 10.1093/sleep/zsaf291.
PubMed 41001841
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder.
- ClinicalTrials.gov ID
- NCT05453136
- Acronym / sponsor ID
- TS142-301
- Conditions
- Patients with Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,155 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 mg | Experimental | Drug: TS-142 5 mgPeriod in which participants received repeated doses of 5 mg TS-142 prior to bedtime |
| 10 mg | Experimental | Drug: TS-142 10 mgPeriod in which participants received repeated doses of 10 mg TS-142 prior to bedtime |
| Placebo | Placebo comparator | Drug: Placebo to TS-142Period in which participants received repeated doses of placebo prior to bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Japanese male and female who are aged 18 years or older at the time of informed consent
- Outpatients
- 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.
Key exclusion criteria (4 listed)
- Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
- Patients with psychiatric disorders such as depression, schizophrenia, and anxiety
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TS-142 5 mgParticipants received repeated doses of 5 mg of TS-142 (oral tablet) | Drug | 5 mg |
| TS-142 10 mgParticipants received repeated doses of 10 mg of TS-142 (oral tablet) | Drug | 10 mg |
| Placebo to TS-142Participants received repeated doses of placebo to TS-142 (oral tablet) | Drug | Placebo |
Primary outcome
Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline
Time frame: Baseline and Week 2
sSL is defined as the duration of time until which subjects fall asleep recorded in a sleep diary.
4 secondary outcomes
Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline
Time frame: Baseline and Week 2
Difference of sTST between TS-142 and placebo in mean change from baseline
Time frame: Baseline and Week 2
Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline
Time frame: Baseline and Week 2
Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline
Time frame: Baseline and Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 41001841Uchiyama M, Kambe D, Hasegawa S, Imadera Y, Yamasaki H, Uchimura N. Efficacy and safety of vornorexant in Japanese patients with insomnia: a randomized, placebo-controlled phase 3 pivotal study. Sleep. 2026 Mar 11;49(3):zsaf291. doi: 10.1093/sleep/zsaf291.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taisho Director study director
Taisho Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TS-142 5 mg and TS-142 10 mg in people with Patients with Insomnia, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline (time frame: Baseline and Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05453136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.