<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/NCT03267303</url>
  </required_header>
  <id_info>
    <org_study_id>TS091-1701</org_study_id>
    <secondary_id>JapicCTI-173689</secondary_id>
    <nct_id>NCT03267303</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy</brief_title>
  <official_title>A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients With Narcolepsy</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>
      The purpose of this study is to investigate the efficacy and safety after administration of&#xD;
      TS-091 compared with placebo in patients with narcolepsy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">August 8, 2019</completion_date>
  <primary_completion_date type="Actual">December 13, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean sleep latency in maintenance of wakefulness test</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total score on the epworth sleepiness scale</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Narcolepsy</condition>
  <arm_group>
    <arm_group_label>TS-091 5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>TS-091 10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TS-091 5mg</intervention_name>
    <description>Orally taken once daily for 3 weeks</description>
    <arm_group_label>TS-091 5mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TS-091 10mg</intervention_name>
    <description>Orally taken once daily for 3 weeks</description>
    <arm_group_label>TS-091 10mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Orally taken once daily for 3 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International&#xD;
             Classification of Sleep Disorders, third edition (ICSD-3) criteria&#xD;
&#xD;
          2. Patients aged ≥16 to &lt;65 years at the time of obtaining informed consent&#xD;
&#xD;
          3. Outpatients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome,&#xD;
             periodic limb movement disorder)&#xD;
&#xD;
          2. Patients with organic brain diseases (including neurodegenerative diseases or&#xD;
             cerebrovascular disorders) or epilepsy&#xD;
&#xD;
          3. Patients with obstructive respiratory diseases (bronchial asthma, emphysema)&#xD;
&#xD;
          4. Patients with psychiatric disorders (e.g., major depressive disorder, bipolar&#xD;
             disorder, schizophrenia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shigeru Okuyama</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>Osaka And Other Japanese City</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taisho Pharmaceutical Co., Ltd selected site</name>
      <address>
        <city>Seoul And Other Korean City</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</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>
  <keyword>Narcolepsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Narcolepsy</mesh_term>
  </condition_browse>
  <!-- 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/NCT03267303
org study id: TS091-1701
secondary id: JapicCTI-173689
nct id: NCT03267303
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the efficacy and safety after administration of
      TS-091 compared with placebo in patients with narcolepsy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean sleep latency in maintenance of wakefulness test
time frame: 3 weeks
measure: Total score on the epworth sleepiness scale
time frame: 3 weeks
arm group label: TS-091 5mg
arm group type: Experimental
arm group label: TS-091 10mg
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: TS-091 5mg
description: Orally taken once daily for 3 weeks
arm group label: TS-091 5mg
intervention type: Drug
intervention name: TS-091 10mg
description: Orally taken once daily for 3 weeks
arm group label: TS-091 10mg
intervention type: Drug
intervention name: Placebo
description: Orally taken once daily for 3 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 16 Years
maximum age: 64 Years
healthy volunteers: No
last name: Shigeru Okuyama
role: Study Director
affiliation: Taisho Pharmaceutical Co., Ltd.
facility: 
facility: 
country: Japan
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Narcolepsy