Insomnia DisorderPhase 2NCT04573725
Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder
A Phase 2 study testing TS-142 in people with Insomnia Disorder, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- TS-142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 7 Jul 2017to 13 Feb 2019
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Outpatients
- Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1
- Other protocol defined inclusion criteria could apply
Who cannot join
- Patients with a history of any of the following diseases according to the DSM-5 criteria:
- Hypersomnolence disorder
- Narcolepsy
- Breathing-related sleep disorders
- Circadian rhythm sleep-wake disorder
- Parasomnias
Show all 12Show fewer
- Restless legs syndrome
- Substance/medication-induced sleep disorder
- Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy
- Patients with a history of poorly controlled diabetes mellitus (HbA1c >8%)
- Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.
- Conditions
- Insomnia Disorder
- Being tested
- TS-142, Dose-matched Placebo to TS-142
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-142Drug
Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Dose-matched Placebo to TS-142Drug
Participants received single dose-matched placebo to TS-142 (oral capsule)
| Study group | Role | What they receive |
|---|---|---|
| 5 mg | Experimental | Period in which participants received single-dose of 5 mg TS-142 prior to bedtime Receives: Drug: TS-142 |
| 10 mg | Experimental | Period in which participants received single-dose of 10 mg TS-142 prior to bedtime Receives: Drug: TS-142 |
| 30 mg | Experimental | Period in which participants received single-dose of 30 mg TS-142 prior to bedtime Receives: Drug: TS-142 |
| Placebo | Placebo comparator | Period in which participants received single placebo prior to bedtime Receives: Drug: Dose-matched Placebo to TS-142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LS mean difference of LPS from placebo
LPS is defined as the duration of time from the light off to the first persistent (10 consecutive minutes) sleep episode as measured by overnight PSG.
Measured: Day 1
LS mean difference of WASO from placebo
WASO is defined as the time spent in wakefulness from the first persistent (10 consecutive minutes) sleep episode to the light on as measured by overnight PSG.
Measured: Day 1
Secondary outcomes (1)
LS mean difference of TST from placebo
TST is defined as the time spent in sleep from the light off to the light on as measured by overnight PSG.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start7 Jul 2017
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
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 Insomnia DisorderStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshiro Heya, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573725
- Sponsor's protocol ID
- TS142-201
- Status last verified
- Oct 2020
- First submitted
- 25 Sep 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
Publications
Uchiyama M, Kambe D, Imadera Y, Kajiyama Y, Ogo H, Uchimura N. Effects of TS-142, a novel dual orexin receptor antagonist, on sleep in patients with insomnia: a randomized, double-blind, placebo-controlled phase 2 study. Psychopharmacology (Berl). 2022 Jul;239(7):2143-2154. doi: 10.1007/s00213-022-06089-6. Epub 2022 Mar 17.
PubMed 35296912
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
- Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder
- ClinicalTrials.gov ID
- NCT04573725
- Acronym / sponsor ID
- TS142-201
- Conditions
- Insomnia Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 5 Oct 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.
Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg | Experimental | Drug: TS-142Period in which participants received single-dose of 5 mg TS-142 prior to bedtime |
| 10 mg | Experimental | Drug: TS-142Period in which participants received single-dose of 10 mg TS-142 prior to bedtime |
| 30 mg | Experimental | Drug: TS-142Period in which participants received single-dose of 30 mg TS-142 prior to bedtime |
| Placebo | Placebo comparator | Drug: Dose-matched Placebo to TS-142Period in which participants received single placebo prior to bedtime |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Outpatients
- Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1
- Other protocol defined inclusion criteria could apply
Key exclusion criteria (12 listed)
- Patients with a history of any of the following diseases according to the DSM-5 criteria:
- Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy
- Patients with a history of poorly controlled diabetes mellitus (HbA1c >8%)
- Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, 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-142Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule) | Drug | 10 mg, 30 mg, 5 mg |
| Dose-matched Placebo to TS-142Participants received single dose-matched placebo to TS-142 (oral capsule) | Drug | Placebo |
Primary outcome
LS mean difference of LPS from placebo
Time frame: Day 1
LPS is defined as the duration of time from the light off to the first persistent (10 consecutive minutes) sleep episode as measured by overnight PSG.
LS mean difference of WASO from placebo
Time frame: Day 1
WASO is defined as the time spent in wakefulness from the first persistent (10 consecutive minutes) sleep episode to the light on as measured by overnight PSG.
1 secondary outcome
LS mean difference of TST from placebo
Time frame: Day 1
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 35296912Uchiyama M, Kambe D, Imadera Y, Kajiyama Y, Ogo H, Uchimura N. Effects of TS-142, a novel dual orexin receptor antagonist, on sleep in patients with insomnia: a randomized, double-blind, placebo-controlled phase 2 study. Psychopharmacology (Berl). 2022 Jul;239(7):2143-2154. doi: 10.1007/s00213-022-06089-6. Epub 2022 Mar 17.
- 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.
Toshiro Heya 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 Insomnia Disorder, 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 12 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 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 of LPS from placebo (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT04573725, 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.