xml: <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/NCT06021522</url>
    </required_header>
    <id_info>
      <org_study_id>EBS-101-TD-391</org_study_id>
      <secondary_id>2023-503545-67-00</secondary_id>
      <nct_id>NCT06021522</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder</brief_title>
    <official_title>A Multicenter, Open-Label, Study to Evaluate the Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Emalex Biosciences Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </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>
        The primary objective of this study is to evaluate the long-term safety and tolerability of&#xD;
        ecopipam tablets in children (greater than or equal to [&gt;=] 6 and less than [&lt;] 12 years of&#xD;
        age), adolescents (&gt;=12 and &lt;18 years of age), and adults (&gt;=18 years of age) with Tourette's&#xD;
        Syndrome (TS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is to evaluate the long-term safety and tolerability of ecopipam tablets in&#xD;
        eligible participants. The eligible participants will be entered into a treatment period and&#xD;
        start a 4-week titration phase to achieve a target steady-state dose of 1.8 milligram per&#xD;
        kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day dose of ecopipam HCl). During the 4-week&#xD;
        titration phase ecopipam will be dispensed following weight bands before reaching their&#xD;
        respective maintenance dose until end of the treatment. Safety assessment will be conducted&#xD;
        at baseline visit and at all treatment visits (Months 1-12, 15, 18, 21 and 24). Safety follow&#xD;
        up visits will be conducted 7 and 14 days and a follow up phone call will be conducted 30&#xD;
        days after the last dose of ecopipam.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 16, 2023</start_date>
    <completion_date type="Anticipated">March 2027</completion_date>
    <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
      <time_frame>Baseline up to Month 24</time_frame>
      <description>An adverse event (AE) is defined as any untoward medical occurrence in a subject administered a study drug and which does not necessarily have a causal relationship with this treatment. A TEAE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Tourette Syndrome</condition>
    <arm_group>
      <arm_group_label>Ecopipam 1.8 mg/kg/day</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ecopipam tablets will be administered orally (PO) once daily in the evening without regard to meals at concentrations 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 milligrams (mg) containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively in 4-week titration phase to achieve a target dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day ecopipam HCl). Participants will be evaluated for safety at each baseline visit and at all treatment visits up to 24 months and at follow up visits at 7 and 14 days after last dose of ecopipam.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ecopipam</intervention_name>
      <description>Selective dopamine D1 and D5 receptor antagonist</description>
      <arm_group_label>Ecopipam 1.8 mg/kg/day</arm_group_label>
      <other_name>Ecopipam Hydrochloride</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &gt;=6 to &gt;=18 years of age.&#xD;
  &#xD;
            -  Participants enrolling from the study EBS-101-TD-301; completed all visits through&#xD;
               Week 24 and days 7 and 14 safety follow-up, met relapse criteria during the&#xD;
               double-blind randomized (R/WD) period after completing the 301 end of trial (ET)&#xD;
               visit, the 7 day and 14 day safety follow up visits, but not before 24 weeks following&#xD;
               the 301 baseline visit or participants who met relapse criteria will be eligible after&#xD;
               completing early termination visit, Day 7 and Day 14 follow up visits.&#xD;
  &#xD;
            -  Participants who completed the studies EBS-101-OL-001 or PSY302A.&#xD;
  &#xD;
            -  The enrolling participant must have had clinical benefit from ecopipam and would&#xD;
               benefit from continued participation.&#xD;
  &#xD;
            -  Effective contraception during the study and 30 days after last study dose for&#xD;
               sexually active participants&#xD;
  &#xD;
            -  &lt;18 years of age participants parent/legal guardian must sign a written informed&#xD;
               consent and participant must sign a written informed assent.&#xD;
  &#xD;
            -  Participant must have TD based on Diagnostic and Statistical Manual for Mental&#xD;
               Disorders - 5th Edition (DSM-5-TR diagnostic criteria) for TD.&#xD;
  &#xD;
            -  TD diagnosis and both motor and vocal tics that cause impairment with normal routines&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The participants who discontinued the studies PSY-302A, EBS-101-OL-001 or&#xD;
               EBS-101-TD-301 due to reasons such as either lost to follow up, withdrawn consent,&#xD;
               non-compliant or withdrawn by the discretion of either the site investigator or the&#xD;
               sponsor.&#xD;
  &#xD;
            -  Participants with ongoing or past history of neurological condition (example [e.g.],&#xD;
               Huntington's disease, Parkinson's disease, Wilson's disease, stroke, Restless Legs&#xD;
               Syndrome).&#xD;
  &#xD;
            -  Any unstable mood disorder (DSM-5-TR criteria), mental illness or clinically&#xD;
               significant lab abnormalities, moderate to severe renal or hepatic impairment, a PHQ-9&#xD;
               score &gt;=10 at screening and history of neuroleptic malignant syndrome at the time of&#xD;
               screening or baseline.&#xD;
  &#xD;
            -  Participants who completed the studies EBS-101-OL-001 or PSY-302A and who had previous&#xD;
               exposure to ecopipam and oral neuroleptics within 4 weeks and depot neuroleptics&#xD;
               within 3 months prior to screening, 6 months prior to Baseline.&#xD;
  &#xD;
            -  Participants receiving any other medication to treat motor or vocal tics and&#xD;
               anti-depressant or anti-anxiety medications.&#xD;
  &#xD;
            -  Risk of suicide as per PI judgement&#xD;
  &#xD;
            -  Pregnant or lactating women&#xD;
  &#xD;
            -  Certain medications that would have unfavorable drug interactions with ecopipam, e.g.,&#xD;
               digoxin, fluoxetine, valproic acid, bupropion.&#xD;
  &#xD;
            -  Current or recent (past 3 months) DSM-5-TR substance use disorder (with the exception&#xD;
               of nicotine).&#xD;
  &#xD;
            -  Recent behavioral therapy&#xD;
  &#xD;
            -  Positive urine drug screen for cocaine, amphetamine, benzodiazepines, barbiturates,&#xD;
               phencyclidine (PCP) or opiates at Baseline, except those receiving stable, prescribed&#xD;
               treatment for attention deficit/hyperactivity disorder (ADHD)&#xD;
  &#xD;
            -  Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any&#xD;
               other psychotic disorder.&#xD;
  &#xD;
            -  Unable to swallow tablets.&#xD;
  &#xD;
            -  Known hypersensitivity to any of ecopipam's excipients.&#xD;
  &#xD;
            -  History of seizures (excluding febrile seizures that occurred &gt;2 years prior to&#xD;
               Baseline).&#xD;
  &#xD;
            -  Myocardial infarction within 6 months from Screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Meredith M Miller</last_name>
      <phone>773 343 0671</phone>
      <email>mmiller@emalexbiosciences.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>David JB Kim</last_name>
      <phone>312 847 1342</phone>
      <email>dkim@emalexbiosciences.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Access Clinical Trials, Inc.</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37203-6502</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>James (Alan) Fry, MD</last_name>
        <phone>615-320-6076</phone>
        <email>drafry@accessclintrials.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ecopipam</keyword>
    <keyword>Neurodevelopmental Disorders</keyword>
    <keyword>Mental Disorders</keyword>
    <keyword>Central Nervous System Depressants</keyword>
    <keyword>Neurodegenerative Diseases</keyword>
    <keyword>Movement Disorders</keyword>
    <keyword>Tic Disorders</keyword>
    <keyword>Nervous System Diseases</keyword>
    <keyword>Central Nervous System Diseases</keyword>
    <keyword>Brain Diseases</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tourette Syndrome</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>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021522
  org study id: EBS-101-TD-391
  secondary id: 2023-503545-67-00
  nct id: NCT06021522
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary objective of this study is to evaluate the long-term safety and tolerability of
        ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of
        age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's
        Syndrome (TS).
  This study is to evaluate the long-term safety and tolerability of ecopipam tablets in
        eligible participants. The eligible participants will be entered into a treatment period and
        start a 4-week titration phase to achieve a target steady-state dose of 1.8 milligram per
        kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day dose of ecopipam HCl). During the 4-week
        titration phase ecopipam will be dispensed following weight bands before reaching their
        respective maintenance dose until end of the treatment. Safety assessment will be conducted
        at baseline visit and at all treatment visits (Months 1-12, 15, 18, 21 and 24). Safety follow
        up visits will be conducted 7 and 14 days and a follow up phone call will be conducted 30
        days after the last dose of ecopipam.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
  time frame: Baseline up to Month 24
  description: An adverse event (AE) is defined as any untoward medical occurrence in a subject administered a study drug and which does not necessarily have a causal relationship with this treatment. A TEAE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product.
  arm group label: Ecopipam 1.8 mg/kg/day
  arm group type: Experimental
  description: Ecopipam tablets will be administered orally (PO) once daily in the evening without regard to meals at concentrations 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 milligrams (mg) containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively in 4-week titration phase to achieve a target dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day ecopipam HCl). Participants will be evaluated for safety at each baseline visit and at all treatment visits up to 24 months and at follow up visits at 7 and 14 days after last dose of ecopipam.
  intervention type: Drug
  intervention name: Ecopipam
  description: Selective dopamine D1 and D5 receptor antagonist
  arm group label: Ecopipam 1.8 mg/kg/day
  other name: Ecopipam Hydrochloride
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meredith M Miller
  phone: 773 343 0671
  email: mmiller@emalexbiosciences.com
  last name: David JB Kim
  phone: 312 847 1342
  email: dkim@emalexbiosciences.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Tourette Syndrome
  mesh term: Ecopipam
  sharing ipd: Undecided