<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/NCT03814135</url>
  </required_header>
  <id_info>
    <org_study_id>EMS0518 - HIPNOS</org_study_id>
    <nct_id>NCT03814135</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia</brief_title>
  <official_title>Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EMS</source>
  <oversight_info>
    <has_dmc>Yes</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 evaluate the efficacy and safety of three doses of Hipnos&#xD;
      medication in adults with insomnia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2021</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">February 2022</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>Double (Participant, Investigator)</masking>
    <masking_description>Duble-blind and double-dummy</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of adverse events recorded during the study.</measure>
    <time_frame>5 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>HIPNOS 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study is double-dummy. Thus, the patient will take 2 tablets, as follow:&#xD;
1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIPNOS 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study is double-dummy. Thus, the patient will take 2 tablets, as follow:&#xD;
1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIPNOS Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hipnos 3</intervention_name>
    <description>1 tablet, oral, once a day.</description>
    <arm_group_label>HIPNOS 3</arm_group_label>
    <other_name>EMS tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hipnos 5</intervention_name>
    <description>1 tablet, oral, once a day.</description>
    <arm_group_label>HIPNOS 5</arm_group_label>
    <other_name>EMS tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hipnos 5 Placebo</intervention_name>
    <description>1 tablet, oral, once a day.</description>
    <arm_group_label>HIPNOS 3</arm_group_label>
    <arm_group_label>HIPNOS Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hipnos 3 Placebo</intervention_name>
    <description>1 tablet, oral, once a day.</description>
    <arm_group_label>HIPNOS 5</arm_group_label>
    <arm_group_label>HIPNOS Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 50 years or more;&#xD;
&#xD;
          -  Diagnosis of insomnia disorder according to criteria defined by the DSM-V;&#xD;
&#xD;
          -  Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the&#xD;
             randomization visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinical and laboratory findings that, in the judgment of the investigator, may&#xD;
             interfere with the safety of research participants;&#xD;
&#xD;
          -  Known hypersensitivity to the formula components used during the clinical trial;&#xD;
&#xD;
          -  Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;&#xD;
&#xD;
          -  History of hepatic impairment;&#xD;
&#xD;
          -  Current smoking;&#xD;
&#xD;
          -  Pregnancy or risk of pregnancy and lactating patients;&#xD;
&#xD;
          -  History of sleep-disordered breathing, sleep disorders associated with changes in&#xD;
             circadian rhythm and severe neurological and psychiatric disorders;&#xD;
&#xD;
          -  Diagnosis of clinical diseases that interfere with sleep;&#xD;
&#xD;
          -  Participants who have used psychostimulant medications, antidepressants and/ or&#xD;
             antipsychotic with sedative effects and/or antiepileptic;&#xD;
&#xD;
          -  Participation in clinical trial in the year prior to this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 30, 2021</last_update_submitted>
  <last_update_submitted_qc>March 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</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/NCT03814135
org study id: EMS0518 - HIPNOS
nct id: NCT03814135
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos
      medication in adults with insomnia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Duble-blind and double-dummy
measure: Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.
time frame: 4 weeks
measure: Incidence and severity of adverse events recorded during the study.
time frame: 5 weeks
arm group label: HIPNOS 3
arm group type: Experimental
description: The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day.
arm group label: HIPNOS 5
arm group type: Experimental
description: The study is double-dummy. Thus, the patient will take 2 tablets, as follow:
1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day.
arm group label: HIPNOS Placebo
arm group type: Placebo Comparator
description: The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day.
intervention type: Drug
intervention name: Hipnos 3
description: 1 tablet, oral, once a day.
arm group label: HIPNOS 3
other name: EMS tablet
intervention type: Drug
intervention name: Hipnos 5
description: 1 tablet, oral, once a day.
arm group label: HIPNOS 5
other name: EMS tablet
intervention type: Other
intervention name: Hipnos 5 Placebo
description: 1 tablet, oral, once a day.
arm group label: HIPNOS 3
arm group label: HIPNOS Placebo
other name: Placebo
intervention type: Other
intervention name: Hipnos 3 Placebo
description: 1 tablet, oral, once a day.
arm group label: HIPNOS 5
arm group label: HIPNOS Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders