NCT04573725

Brief Summary

Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

February 28, 2025

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

September 25, 2020

Last Update Submit

February 26, 2025

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 1

Secondary Outcomes (1)

  • LS mean difference of TST from placebo

    Day 1

Study Arms (4)

5 mg

EXPERIMENTAL

Period in which participants received single-dose of 5 mg TS-142 prior to bedtime

Drug: TS-142

10 mg

EXPERIMENTAL

Period in which participants received single-dose of 10 mg TS-142 prior to bedtime

Drug: TS-142

30 mg

EXPERIMENTAL

Period in which participants received single-dose of 30 mg TS-142 prior to bedtime

Drug: TS-142

Placebo

PLACEBO COMPARATOR

Period in which participants received single placebo prior to bedtime

Drug: Dose-matched Placebo to TS-142

Interventions

TS-142DRUG

Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)

10 mg30 mg5 mg
Dose-matched Placebo to TS-142DRUG

Participants received single dose-matched placebo to TS-142 (oral capsule)

Placebo

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 35296912DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

TS-142

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Toshiro Heya

    Taisho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 5, 2020

Study Start

July 7, 2017

Primary Completion

February 13, 2019

Study Completion

February 13, 2019

Last Updated

February 28, 2025

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)