<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04469023</url>
  </required_header>
  <id_info>
    <org_study_id>TS142-203</org_study_id>
    <nct_id>NCT04469023</nct_id>
  </id_info>
  <brief_title>Late Phase II Study of TS-142 in Patients With Insomnia</brief_title>
  <official_title>Late Phase II Study of TS-142 in Patients With Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taisho Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taisho Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group&#xD;
      exploratory study in patients with insomnia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Actual">November 16, 2021</completion_date>
  <primary_completion_date type="Actual">November 16, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LS mean difference from placebo; Change between baseline and end of the study of sSL</measure>
    <time_frame>Baseline and Week 2</time_frame>
    <description>sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LS mean difference from placebo; Change between baseline and end of the study of sTST</measure>
    <time_frame>Baseline and Week 2</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LS mean difference from placebo; Change between baseline and end of the study of sWASO</measure>
    <time_frame>Baseline and Week 2</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">179</enrollment>
  <condition>Patients With Insomnia</condition>
  <arm_group>
    <arm_group_label>TS-142 2.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TS-142 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TS-142 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period in which participants received single placebo prior to bedtime</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TS-142</intervention_name>
    <description>Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>TS-142 10 mg</arm_group_label>
    <arm_group_label>TS-142 2.5 mg</arm_group_label>
    <arm_group_label>TS-142 5 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Japanese male and female age 20 years or older at the time of informed consent&#xD;
&#xD;
          -  Outpatients&#xD;
&#xD;
          -  Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth&#xD;
             edition (DSM-5) criteria for insomnia disorder&#xD;
&#xD;
          -  Other protocol defined inclusion criteria could apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth&#xD;
             edition (DSM-5) criteria excepting insomnia disorder preceding visit 1&#xD;
&#xD;
          -  Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1&#xD;
&#xD;
          -  Patients with comorbid psychiatric disorder(s), including depression, schizophrenia,&#xD;
             anxiety&#xD;
&#xD;
          -  Other protocol defined exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taisho Director</last_name>
    <role>Study Director</role>
    <affiliation>Taisho Pharmaceutical Co., Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taisho Pharmaceutical Co., Ltd selected site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469023
org study id: TS142-203
nct id: NCT04469023
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group
      exploratory study in patients with insomnia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: LS mean difference from placebo; Change between baseline and end of the study of sSL
time frame: Baseline and Week 2
description: sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary
measure: LS mean difference from placebo; Change between baseline and end of the study of sTST
time frame: Baseline and Week 2
description: 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
measure: LS mean difference from placebo; Change between baseline and end of the study of sWASO
time frame: Baseline and Week 2
description: 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.
arm group label: TS-142 2.5 mg
arm group type: Experimental
description: Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime
arm group label: TS-142 5 mg
arm group type: Experimental
description: Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime
arm group label: TS-142 10 mg
arm group type: Experimental
description: Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime
arm group label: Placebo
arm group type: Experimental
description: Period in which participants received single placebo prior to bedtime
intervention type: Drug
intervention name: TS-142
description: Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
arm group label: Placebo
arm group label: TS-142 10 mg
arm group label: TS-142 2.5 mg
arm group label: TS-142 5 mg
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Taisho Director
role: Study Director
affiliation: Taisho Pharmaceutical Co., Ltd.
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No