Patients with InsomniaPhase 2NCT04469023
Late Phase II Study of TS-142 in Patients with Insomnia
A Phase 2 study testing TS-142 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 exploratory study in patients with insomnia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients with Insomnia
- What is being tested?
- TS-142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteJapan
- Study dates
- 9 Sep 2020to 16 Nov 2021
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group exploratory study in patients with insomnia.
- Conditions
- Patients with Insomnia
- Being tested
- TS-142
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-142Drug
Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
| Study group | Role | What they receive |
|---|---|---|
| TS-142 2.5 mg | Experimental | Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime Receives: Drug: TS-142 |
| TS-142 5 mg | Experimental | Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime Receives: Drug: TS-142 |
| TS-142 10 mg | Experimental | Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime Receives: Drug: TS-142 |
| Placebo | Experimental | Period in which participants received single placebo prior to bedtime Receives: Drug: TS-142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 2
Secondary outcomes (2)
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
Measured: Baseline and Week 2
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.
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 posted13 Jul 2020
- Study start9 Sep 2020
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 179 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
- NCT04469023
- Sponsor's protocol ID
- TS142-203
- Status last verified
- Dec 2021
- First submitted
- 8 Jul 2020
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Late Phase II Study of TS-142 in Patients with Insomnia
- ClinicalTrials.gov ID
- NCT04469023
- Acronym / sponsor ID
- TS142-203
- Conditions
- Patients with Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 13 Jul 2020 (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 exploratory 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
- 4
| Arm | Type | Receives |
|---|---|---|
| TS-142 2.5 mg | Experimental | Drug: TS-142Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime |
| TS-142 5 mg | Experimental | Drug: TS-142Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime |
| TS-142 10 mg | Experimental | Drug: TS-142Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime |
| Placebo | Experimental | Drug: TS-142Period in which participants received single placebo prior to bedtime |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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-142Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet) | Drug | Placebo, TS-142 10 mg, TS-142 2.5 mg, TS-142 5 mg |
Primary outcome
LS mean difference from placebo; Change between baseline and end of the study of sSL
Time frame: Baseline and Week 2
sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary
2 secondary outcomes
LS mean difference from placebo; Change between baseline and end of the study of sTST
Time frame: Baseline and Week 2
LS mean difference from placebo; Change between baseline and end of the study of sWASO
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.
- 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 2 study testing TS-142 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
LS mean difference from placebo; Change between baseline and end of the study of sSL (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?
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.