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

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

Study Overview

• Status: Completed
• Conditions: Insomnia Disorder
• Intervention / Treatment: Drug: TS-142; Drug: Dose-matched Placebo to TS-142

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg; Period in which participants received single-dose of 5 mg TS-142 prior to bedtime	Drug: TS-142; Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Experimental: 10 mg; Period in which participants received single-dose of 10 mg TS-142 prior to bedtime	Drug: TS-142; Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Experimental: 30 mg; Period in which participants received single-dose of 30 mg TS-142 prior to bedtime	Drug: TS-142; Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Placebo Comparator: Placebo; Period in which participants received single placebo prior to bedtime	Drug: Dose-matched Placebo to TS-142; Participants received single dose-matched placebo to TS-142 (oral capsule)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Toshiro Heya, Taisho Pharmaceutical Co., Ltd.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: TS142-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No