<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/NCT01710631</url>
  </required_header>
  <id_info>
    <org_study_id>190-049</org_study_id>
    <nct_id>NCT01710631</nct_id>
  </id_info>
  <brief_title>Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled and Open-Label Twelve Month Study of the Safety of (S)-Zopiclone in Adult Subjects With Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sumitomo Pharma America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sumitomo Pharma America, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A six-month study to determine the safety and efficacy with an additional open-label&#xD;
      extension to determine the long-term safety of eszopiclone in the treatment of adult subjects&#xD;
      with primary insomnia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A six month, randomized, double-blind and six month open-label extension, multi-center,&#xD;
      outpatient study to determine the safety of eszopiclone in the treatment of adult subjects&#xD;
      with primary insomnia. Approximately 800 subjects were to be randomized using a 3:1 ratio to&#xD;
      receive one of the two treatments, eszopiclone 3 mg or placebo, for 6 months. All subjects&#xD;
      completing 6 months of treatment were eligible to receive open-label 3 mg eszopiclone for an&#xD;
      additional 6 months. Subjects were allowed to stay on study for up to 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2001</start_date>
  <completion_date type="Actual">August 2002</completion_date>
  <primary_completion_date type="Actual">August 2002</primary_completion_date>
  <phase>Phase 3</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>Average sleep latency over the last half of the double-blind study period (&quot;last-three-month average&quot; = mean of the monthly averages for months 4, 5, and 6)</measure>
    <time_frame>Months 4-6</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of Adverse Events (AEs) to evaluate the safety of eszopiclone</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Total sleep time</measure>
    <time_frame>Months 4-6 average</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Sleep latency</measure>
    <time_frame>Months 1-3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of awakenings</measure>
    <time_frame>Months 1-12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake Time After Sleep Onset (WASO)</measure>
    <time_frame>Months 1-12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep</measure>
    <time_frame>Months 1-12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE's</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total sleep time</measure>
    <time_frame>Months 1-3</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">791</enrollment>
  <condition>Primary Insomnia</condition>
  <arm_group>
    <arm_group_label>eszopiclone 3 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>eszopiclone 3 mg</intervention_name>
    <description>eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).</description>
    <arm_group_label>eszopiclone 3 mg</arm_group_label>
    <other_name>lunesta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition&#xD;
             (DSM-IV) criteria for primary insomnia and reported sleeping no more than 6.5 hours&#xD;
             per night and/or taking more than 30 minutes each night to fall asleep for at least&#xD;
             one month prior to screening.&#xD;
&#xD;
          -  Subject was between 21 and 64 years of age (inclusive) at screening. Both males and&#xD;
             females were eligible to participate.&#xD;
&#xD;
          -  Subject provided written informed consent indicating that the purpose of the study was&#xD;
             understood. The subject was willing to adhere to the regimen and study procedures&#xD;
             described in this protocol.&#xD;
&#xD;
          -  Females of childbearing potential must have willingly signed &quot;Women of Child-Bearing&#xD;
             Potential Informed Consent&quot; addendum. Females considered not of childbearing potential&#xD;
             must have been surgically sterile or greater than one-year post-menopausal, defined as&#xD;
             a complete cessation of menstruation for at least one year.&#xD;
&#xD;
          -  Subject's physical examination, including a brief neurological examination, showed no&#xD;
             clinically significant abnormal findings at screening.&#xD;
&#xD;
          -  Subject had no known clinically significant abnormal laboratory findings at screening.&#xD;
&#xD;
          -  Subject had no clinically significant Electrocardiography (ECG) abnormalities at&#xD;
             screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject had any clinically significant unstable medical abnormality, chronic disease,&#xD;
             or a history of a clinically significant abnormality of the cardiovascular,&#xD;
             respiratory, hepatic, or renal systems.&#xD;
&#xD;
          -  Subject had a history of, or current malignancy except for non-melanomatous skin&#xD;
             cancer.&#xD;
&#xD;
          -  Subject had objective evidence of active thyroid disease at screening. Subjects on&#xD;
             thyroid replacement therapy were included as long as dose had been stable for ≥ 3&#xD;
             months.&#xD;
&#xD;
          -  Subject had a DSM-IV Axis I psychiatric diagnosis other than Sexual and Gender&#xD;
             Identity Disorders, or Axis II Personality Disorders (but not schizotypal, schizoid,&#xD;
             or borderline personality disorder). Other non-psychotic Axis I disorders except&#xD;
             dementia and delirium were considered on a case-by-case basis.&#xD;
&#xD;
          -  Subject had a known sensitivity to racemic zopiclone, any benzodiazepine, any sedative&#xD;
             hypnotic, any substance that was contained in the formulation, or had been&#xD;
             hospitalized for any allergic conditions (e.g. recurrent dermatitis, drug&#xD;
             hypersensitivity, drug allergy, etc.).&#xD;
&#xD;
          -  Subject had difficulties in sleep initiation or maintenance associated with known&#xD;
             sleep difficulties (e.g. sleep apnea, restless leg syndrome, (RLS) or periodic leg&#xD;
             movement syndrome (PLMS)), or had any condition which had, or may, affect sleep (e.g.,&#xD;
             chronic pain, Benign prostatic hyperplasia (BPH), etc.).&#xD;
&#xD;
          -  Subject had history of substance abuse in the past 10 years or substance dependence at&#xD;
             any time; positive urine drug test at screening.&#xD;
&#xD;
          -  Subject tested positive at screening for hepatitis B surface antigen, hepatitis C&#xD;
             antibody or had a history of a positive result.&#xD;
&#xD;
          -  Subject was known to be seropositive for Human immunodeficiency virus (HIV).&#xD;
&#xD;
          -  Female subjects who were pregnant, lactating or within 6 months post-partum.&#xD;
&#xD;
          -  Subject had a disorder or history of a condition (e.g., malabsorption,&#xD;
             gastrointestinal surgery) that may have interfered with drug absorption, distribution,&#xD;
             metabolism, or excretion.&#xD;
&#xD;
          -  Subject had used any drugs known or suspected to affect hepatic or renal clearance&#xD;
             capacity within a period of 30 days prior to screening.&#xD;
&#xD;
          -  Subject self-reported consumption of more than two alcoholic beverages daily, 14 or&#xD;
             more alcoholic beverages weekly, or five or more alcoholic beverages on any given day.&#xD;
&#xD;
          -  Subject had taken any psychotropic medications or other medications known to affect&#xD;
             sleep within the 3 days prior to screening visit or was anticipated to need any of&#xD;
             these types of medications during double-blind treatment.&#xD;
&#xD;
          -  Subject had participated in any investigational study within 30 days prior to&#xD;
             screening.&#xD;
&#xD;
          -  Subject had taken herbal supplements, purported to have central nervous system&#xD;
             effects, (tablets, powders, extracts or tinctures) or combination products with herbs&#xD;
             or melatonin within 14 days prior to screening or St. John's Wort within 30 days prior&#xD;
             to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lunesta Medical Director, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sumitomo Pharma America, Inc.</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>October 18, 2012</last_update_submitted>
  <last_update_submitted_qc>October 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleep</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eszopiclone</mesh_term>
  </intervention_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/NCT01710631
org study id: 190-049
nct id: NCT01710631
lead sponsor: 
has dmc: No
A six-month study to determine the safety and efficacy with an additional open-label
      extension to determine the long-term safety of eszopiclone in the treatment of adult subjects
      with primary insomnia.
A six month, randomized, double-blind and six month open-label extension, multi-center,
      outpatient study to determine the safety of eszopiclone in the treatment of adult subjects
      with primary insomnia. Approximately 800 subjects were to be randomized using a 3:1 ratio to
      receive one of the two treatments, eszopiclone 3 mg or placebo, for 6 months. All subjects
      completing 6 months of treatment were eligible to receive open-label 3 mg eszopiclone for an
      additional 6 months. Subjects were allowed to stay on study for up to 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Average sleep latency over the last half of the double-blind study period ("last-three-month average" = mean of the monthly averages for months 4, 5, and 6)
time frame: Months 4-6
measure: Occurrence of Adverse Events (AEs) to evaluate the safety of eszopiclone
time frame: 12 Months
measure: Subjective Total sleep time
time frame: Months 4-6 average
measure: Subjective Sleep latency
time frame: Months 1-3
measure: Number of awakenings
time frame: Months 1-12
measure: Wake Time After Sleep Onset (WASO)
time frame: Months 1-12
measure: Quality of Sleep
time frame: Months 1-12
measure: AE's
time frame: 12 months
measure: Total sleep time
time frame: Months 1-3
arm group label: eszopiclone 3 mg
arm group type: Experimental
description: eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).
arm group label: placebo
arm group type: Placebo Comparator
description: placebo tablet
intervention type: Drug
intervention name: eszopiclone 3 mg
description: eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).
arm group label: eszopiclone 3 mg
other name: lunesta
intervention type: Drug
intervention name: placebo
description: placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 64 Years
healthy volunteers: No
last name: Lunesta Medical Director, MD
role: Study Director
affiliation: Sumitomo Pharma America, Inc.
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Eszopiclone