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Early Phase 2 Clinical Study of TS-142 in Patients With Insomnia Disorder

Primary Purpose

Insomnia Disorder

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
TS-142
Dose-matched Placebo to TS-142
Sponsored by
Taisho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Disorder

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with a history of any of the following diseases according to the DSM-5 criteria:

    1. Hypersomnolence disorder
    2. Narcolepsy
    3. Breathing-related sleep disorders
    4. Circadian rhythm sleep-wake disorder
    5. Parasomnias
    6. Restless legs syndrome
    7. 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

Sites / Locations

  • Taisho Pharmaceutical Co., Ltd selected site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

5 mg

10 mg

30 mg

Placebo

Arm Description

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

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

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

Period in which participants received single placebo prior to bedtime

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 25, 2020
Last Updated
October 4, 2022
Sponsor
Taisho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04573725
Brief Title
Early Phase 2 Clinical Study of TS-142 in Patients With Insomnia Disorder
Official Title
Early Phase 2 Clinical Study of TS-142 in Patients With Insomnia Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 7, 2017 (Actual)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
February 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taisho Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 mg
Arm Type
Experimental
Arm Description
Period in which participants received single-dose of 5 mg TS-142 prior to bedtime
Arm Title
10 mg
Arm Type
Experimental
Arm Description
Period in which participants received single-dose of 10 mg TS-142 prior to bedtime
Arm Title
30 mg
Arm Type
Experimental
Arm Description
Period in which participants received single-dose of 30 mg TS-142 prior to bedtime
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Period in which participants received single placebo prior to bedtime
Intervention Type
Drug
Intervention Name(s)
TS-142
Intervention Description
Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Intervention Type
Drug
Intervention Name(s)
Dose-matched Placebo to TS-142
Intervention Description
Participants received single dose-matched placebo to TS-142 (oral capsule)
Primary Outcome Measure Information:
Title
LS mean difference of LPS from placebo
Description
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.
Time Frame
Day 1
Title
LS mean difference of WASO from placebo
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
LS mean difference of TST from placebo
Description
TST is defined as the time spent in sleep from the light off to the light on as measured by overnight PSG.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Other protocol defined exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiro Heya
Organizational Affiliation
Taisho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Taisho Pharmaceutical Co., Ltd selected site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35296912
Citation
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.
Results Reference
derived

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Early Phase 2 Clinical Study of TS-142 in Patients With Insomnia Disorder

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