<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/NCT04492956</url>
  </required_header>
  <id_info>
    <org_study_id>EBS-101-COFD-201</org_study_id>
    <nct_id>NCT04492956</nct_id>
  </id_info>
  <brief_title>Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Exploratory Study to Evaluate the Efficacy and Safety of Ecopipam Tablets in Adults With Childhood Onset Fluency Disorder (Stuttering)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emalex Biosciences Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Riverside</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Premier Research Group plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Emalex Biosciences Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2&#xD;
      exploratory study in adult subjects with childhood onset fluency disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target&#xD;
      steady-state dose of ecopipam HCl ~2 mg/kg/day or matching placebo for a 12-week Treatment&#xD;
      Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase.&#xD;
&#xD;
      Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up&#xD;
      visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy&#xD;
      assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted&#xD;
      at all visits. Subjects will have adverse events and other safety parameters assessed by&#xD;
      phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug&#xD;
      administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored&#xD;
      throughout the study.&#xD;
&#xD;
      At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug&#xD;
      by 25 mg/day until off study drug, for up to 1 week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2020</start_date>
  <completion_date type="Actual">April 4, 2022</completion_date>
  <primary_completion_date type="Actual">March 7, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measures stuttering severity in children and adults</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Severity (CGI-S) baseline to Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>Rates the severity of the subject's illness at the time of assessment, relative to the the clinician's past experience with patients who have the same diagnosis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Childhood-Onset Fluency Disorder (Stuttering)</condition>
  <arm_group>
    <arm_group_label>Ecopipam HCl ~2mg/kg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo tablets for daily, oral administration for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ecopipam</intervention_name>
    <description>Oral tablet</description>
    <arm_group_label>Ecopipam HCl ~2mg/kg/day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral tablet</description>
    <arm_group_label>Matching Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to read and write in English and provide informed consent&#xD;
&#xD;
          -  18 years or older of age at screening&#xD;
&#xD;
          -  Weighs &gt;= 45 kg (~99 lbs)&#xD;
&#xD;
          -  Satisfies DSM-5 criteria for childhood onset fluency disorder&#xD;
&#xD;
          -  History of stuttering for &gt;=2 years with onset consistent to developmental in nature&#xD;
&#xD;
          -  Must meet an allowed severity of stuttering at screening and baseline, scored by a&#xD;
             central rater&#xD;
&#xD;
          -  Completed an adequate course of speech therapy&#xD;
&#xD;
          -  Has a qualifying IOS or Android smartphone&#xD;
&#xD;
          -  Must discontinue all medications used to treat stuttering for at least 14 days prior&#xD;
             to screening&#xD;
&#xD;
          -  Sexually active females of child bearing potential must be using effective&#xD;
             contraception during and 30 days after participation&#xD;
&#xD;
          -  Sexually active males must use a double barrier method of contraception during and 30&#xD;
             days after participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stuttering is related to a known neurological cause&#xD;
&#xD;
          -  Initiation of new behavioral therapies for stuttering within 10 weeks prior to&#xD;
             baseline&#xD;
&#xD;
          -  Unstable medical illness or clinically significant abnormalities on screening&#xD;
             tests/exams&#xD;
&#xD;
          -  At a significant risk of committing suicide&#xD;
&#xD;
          -  Are pregnant or lactating&#xD;
&#xD;
          -  Positive urine drug screen&#xD;
&#xD;
          -  Lifetime history of major depressive episode&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Have been previously treated with ecopipam&#xD;
&#xD;
          -  Unstable use of medications prior to screening&#xD;
&#xD;
          -  Use of prohibited medications or need for medications which would have unfavorable&#xD;
             interactions with ecopipam&#xD;
&#xD;
          -  Not suitable for study in the opinion of the Principle Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Atul R Mahableshwarkar, MD, DFAPA</last_name>
    <role>Study Director</role>
    <affiliation>Emalex Biosciences Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Riverside</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Trials</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions Inc</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions Inc</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute For Advanced Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Social Psychiatry Research Institute</name>
      <address>
        <city>Prairie Village</city>
        <state>Kansas</state>
        <zip>66208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48824</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Social Psychiatry Research Institute</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions Inc</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stuttering</keyword>
  <keyword>Communication Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stuttering</mesh_term>
    <mesh_term>Childhood-Onset Fluency Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ecopipam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 20, 2023</submitted>
    <returned>April 13, 2023</returned>
  </pending_results>
  <!-- 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/NCT04492956
org study id: EBS-101-COFD-201
nct id: NCT04492956
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2
      exploratory study in adult subjects with childhood onset fluency disorder.
At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target
      steady-state dose of ecopipam HCl ~2 mg/kg/day or matching placebo for a 12-week Treatment
      Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase.

      Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up
      visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy
      assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted
      at all visits. Subjects will have adverse events and other safety parameters assessed by
      phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug
      administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored
      throughout the study.

      At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug
      by 25 mg/day until off study drug, for up to 1 week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12
time frame: 12 weeks
description: Measures stuttering severity in children and adults
measure: Clinical Global Impression - Severity (CGI-S) baseline to Week 12
time frame: 12 weeks
description: Rates the severity of the subject's illness at the time of assessment, relative to the the clinician's past experience with patients who have the same diagnosis.
arm group label: Ecopipam HCl ~2mg/kg/day
arm group type: Experimental
description: Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks
arm group label: Matching Placebo
arm group type: Placebo Comparator
description: Matching placebo tablets for daily, oral administration for 12 weeks
intervention type: Drug
intervention name: Ecopipam
description: Oral tablet
arm group label: Ecopipam HCl ~2mg/kg/day
intervention type: Drug
intervention name: Placebo
description: Oral tablet
arm group label: Matching Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Atul R Mahableshwarkar, MD, DFAPA
role: Study Director
affiliation: Emalex Biosciences Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stuttering
mesh term: Childhood-Onset Fluency Disorder
mesh term: Ecopipam
sharing ipd: No
submitted: March 20, 2023
returned: April 13, 2023