<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/NCT03797521</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-201</org_study_id>
    <nct_id>NCT03797521</nct_id>
  </id_info>
  <brief_title>A Study in Patients With Trichotillomania</brief_title>
  <acronym>TTM</acronym>
  <official_title>A Phase 2, Double Blind, Placebo-Controlled Study to Explore the Safety, Tolerability, and Activity of SXC-2023 in Adults With Moderate to Severe Trichotillomania (TTM) When Dosed for 6 Weeks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Promentis Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Promentis Pharmaceuticals, 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 purpose of this study is to explore the safety, tolerability and activity of SXC-2023&#xD;
      when dosed for 6 weeks versus placebo in adult patients with moderate to severe&#xD;
      Trichotillomania.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study&#xD;
      consisting of a screening period of up to 40 days, a 6 week randomized double-blind treatment&#xD;
      period, followed by an up to 2 week safety follow-up period after the last dose of study&#xD;
      medication.&#xD;
&#xD;
      Patients will be randomized to one of four treatment groups. Patients will participate for a&#xD;
      total of up to 10 weeks, including screening, the 6-week treatment period and follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Actual">December 16, 2019</completion_date>
  <primary_completion_date type="Actual">December 2, 2019</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>
    <masking_description>Double-blind, Placebo-controlled Study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM</measure>
    <time_frame>Up to 7 weeks</time_frame>
    <description>Safety and tolerability assessed using the frequency of subjects with serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline hairpulling frequency and severity through 6 weeks</measure>
    <time_frame>Up to 7 weeks</time_frame>
    <description>Improvement will be assessed using the different measurement parameters of all scales using scales such as the Massachusetts General Hospital Hairpulling scale (MGH-HPS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline hairpulling frequency and severity through 6 weeks</measure>
    <time_frame>Up to 7 weeks</time_frame>
    <description>Improvement will be assessed using the different measurement parameters of all scales using scales such as the Clinical Global Impression of Severity and Change (CGI-S/C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline hairpulling frequency and severity through 6 weeks</measure>
    <time_frame>Up to 7 weeks</time_frame>
    <description>Improvement will be assessed using the different measurement parameters of all scales using scales such as the Patient Global Impression of Status and Change (PGI-S/C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline hairpulling frequency and severity daily through 6 weeks</measure>
    <time_frame>Up to 7 weeks</time_frame>
    <description>Improvement will be assessed using the different measurement parameters of all scales using scales such as the Trichotillomania Symptom Diary (TSD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary psychometric evidence of the Trichotillomania Symptom Diary (TSD) will be assessed</measure>
    <time_frame>Up to 7 weeks</time_frame>
    <description>The reliability, validity and responsiveness of the newly developed TSD assessment will be assessed at the item level.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Trichotillomania</condition>
  <arm_group>
    <arm_group_label>SXC-2023 50mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SXC-2023 50mg dosed once daily for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SXC-2023 200mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SXC-2023 200mg dosed once daily for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SXC-2023 800mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SXC-2023 800mg dosed once daily for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching Placebo QD</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching Placebo dosed once daily for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SXC-2023</intervention_name>
    <description>SXC-2023 oral capsules</description>
    <arm_group_label>SXC-2023 200mg QD</arm_group_label>
    <arm_group_label>SXC-2023 50mg QD</arm_group_label>
    <arm_group_label>SXC-2023 800mg QD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching Placebo oral capsules</description>
    <arm_group_label>Matching Placebo QD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Adult, female or male, 18-45 years of age, inclusive at screening.&#xD;
&#xD;
          2. Provided signed written informed consent with willingness and ability to comply with&#xD;
             all aspects of the protocol.&#xD;
&#xD;
          3. Diagnosis of current TTM based on Diagnostic and Statistical Manual of Mental&#xD;
             Disorders, fifth edition (DSM-5) criteria and confirmed using the&#xD;
             clinician-administered MINI-TTM. In addition, subjects should:&#xD;
&#xD;
               1. Have a history of TTM for at least one year&#xD;
&#xD;
               2. Have a history of daily hair pulling for at least 6 months prior to the first&#xD;
                  dose&#xD;
&#xD;
          4. Except for SSRIs or SNRIs, has not used any psychoactive medications including, but&#xD;
             not limited to, other antidepressants, anxiolytics, mood stabilizers, anti-psychotics,&#xD;
             benzodiazepines, stimulants, sulfasalazine, and St. John's Wort 30 days prior to first&#xD;
             dose. Subjects will be allowed to maintain background therapy with SSRIs or SNRIs if&#xD;
             on stable regimen for a minimum of 90 days prior to first dose and there are no&#xD;
             anticipated changes to the SSRI/SNRI during course of trial.&#xD;
&#xD;
          5. Has not used N-acetylcysteine for at least 90 days prior to the first dose.&#xD;
&#xD;
          6. Has not used gemfibrozil or repaglinide for 1 week prior to the first screening visit.&#xD;
&#xD;
          7. Medically healthy with no clinically significant findings in medical history, physical&#xD;
             examination, laboratory profiles, vital signs, or ECGs, as deemed by the Principal&#xD;
             Investigator (PI) or designee.&#xD;
&#xD;
          8. For a female of childbearing potential: either be sexually inactive (abstinent as a&#xD;
             life style) for 28 days prior to the first dosing and throughout the study or be using&#xD;
             one of the following acceptable birth control options:&#xD;
&#xD;
               -  Oral contraception for at least 3 months prior to the first dosing along with&#xD;
                  either a physical (e.g., condom, diaphragm) or a chemical (e.g., spermicide)&#xD;
                  barrier method from the time of screening and throughout the study&#xD;
&#xD;
               -  IUD (either hormone-releasing or non-hormone releasing) for at least minimum&#xD;
                  duration per current labeling along with either a physical (e.g., condom,&#xD;
                  diaphragm) or a chemical (e.g., spermicide) barrier method from the time of&#xD;
                  screening and throughout the study&#xD;
&#xD;
               -  Depo contraception for at least minimum duration per current labeling prior to&#xD;
                  the first dosing along with either a physical (e.g., condom, diaphragm) or a&#xD;
                  chemical (e.g., spermicide) barrier method from the time of screening and&#xD;
                  throughout the study&#xD;
&#xD;
               -  Double physical barrier method (e.g., condom and diaphragm) from 14 days prior to&#xD;
                  the first dose and throughout the study&#xD;
&#xD;
               -  Physical plus chemical barrier method (e.g., condom with spermicide) from 14 days&#xD;
                  prior to the first dose and throughout the study.&#xD;
&#xD;
             In addition, female subjects of childbearing potential will be advised to remain&#xD;
             sexually inactive or to keep the same birth control method for at least 30 days&#xD;
             following the last dose.&#xD;
&#xD;
          9. Female of non childbearing potential: must have undergone one of the following&#xD;
             sterilization procedures, at least 6 months prior to the first dose:&#xD;
&#xD;
               -  hysteroscopic sterilization;&#xD;
&#xD;
               -  bilateral tubal ligation or bilateral salpingectomy;&#xD;
&#xD;
               -  hysterectomy;&#xD;
&#xD;
               -  bilateral oophorectomy; Or be postmenopausal with amenorrhea for at least 1 year&#xD;
                  prior to the first dose with serum follicle stimulating hormone levels consistent&#xD;
                  with postmenopausal status or have medically documented history of biological or&#xD;
                  congenital sterility.&#xD;
&#xD;
         10. A non vasectomized, male subject must agree to use a condom with spermicide or abstain&#xD;
             from sexual intercourse during the study until 30 days beyond the last dose of study&#xD;
             drug/placebo.&#xD;
&#xD;
         11. If male, must agree not to donate sperm from the first dose until 30 days after the&#xD;
             last dose administration.&#xD;
&#xD;
         12. Must be able to fluently read and write in English.&#xD;
&#xD;
         13. Understands the study procedures in the informed consent form (ICF) and is willing and&#xD;
             able to comply with the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant or breastfeeding or intend to become pregnant during the&#xD;
             study period or within 30 days of the final dose of study drug.&#xD;
&#xD;
          2. Subjects engaged in cognitive behavioral therapy (CBT) for TTM or other body-focused&#xD;
             repetitive behavior or any obsessive-compulsive related or impulse control disorder&#xD;
             any time within 60 days prior to first dose. For other psychotherapies, subject must&#xD;
             have been engaged in that psychotherapy for a minimum of 60 days at the time of first&#xD;
             dose and must be willing to maintain the same frequency and type of therapy for the&#xD;
             duration of the study period.&#xD;
&#xD;
          3. Subjects engaged in any other behavioral interventions (e.g., wearable devices,&#xD;
             behavioral self-help strategies) within 60 days prior to first dose.&#xD;
&#xD;
          4. Mentally or legally incompetent.&#xD;
&#xD;
          5. Suffered a concussion in the past 6 months prior to screening. Any history of&#xD;
             traumatic brain injury with loss of consciousness in the year prior to first screening&#xD;
             visit.&#xD;
&#xD;
          6. Any lifetime history of any psychotic disorder, including schizophrenia or any bipolar&#xD;
             or bipolar-related disorder as determined by clinical history or confirmed at&#xD;
             screening with the MINI, version 7.0.2.&#xD;
&#xD;
          7. Current major depressive episode confirmed at screening with the MINI, version 7.0.2.&#xD;
&#xD;
          8. Per PI judgment, the presence of any emotional problems or psychiatric disorders that&#xD;
             may obscure evaluation of primary TTM or pose a risk to subject safety or stability&#xD;
             during the study period. Other emotional problems or diagnoses may include, but are&#xD;
             not limited to, other body-focused repetitive behaviors, post-traumatic stress&#xD;
             disorder, obsessive-compulsive disorder, panic disorder, compulsive gambling,&#xD;
             borderline personality disorder, or antisocial personality disorder.&#xD;
&#xD;
          9. History of any injury, illness, or condition that, in the opinion of the PI or&#xD;
             designee, might confound the results of the study or poses an additional risk to the&#xD;
             subject by their participation in the study.&#xD;
&#xD;
         10. Laboratory evidence of renal impairment (e.g. a creatine clearance of &lt; 80)&#xD;
&#xD;
         11. Presence of any substance use disorder or, in the opinion of the PI or designee,&#xD;
             problematic substance use (excluding nicotine or caffeine) within the 2 years prior to&#xD;
             screening.&#xD;
&#xD;
         12. History of seizure disorder with the exception of subjects who have been off&#xD;
             anti-seizure medication and have not had a seizure in the past 5 years.&#xD;
&#xD;
         13. Subjects with any of the following:&#xD;
&#xD;
               1. Any psychiatric hospitalizations in the past year,&#xD;
&#xD;
               2. Imminent risk of suicide based on PI's or designee's clinical judgment or&#xD;
                  psychiatric examination,&#xD;
&#xD;
               3. Active suicidal ideation in the past 6 months as evidenced by positive&#xD;
                  endorsement to Item 4 or 5 on the C-SSRS, OR&#xD;
&#xD;
               4. Any history of suicidal behavior in the past year as evidenced by positive&#xD;
                  endorsement to any of the suicidal behavior items on the C-SSRS.&#xD;
&#xD;
         14. Has previously participated in any Promentis Phase 1 study.&#xD;
&#xD;
         15. Participation in another interventional clinical study (including CBT or other&#xD;
             behavioral intervention) within 30 days prior to the first screening visit. The 30 day&#xD;
             window will be derived from the date of the last blood collection or dosing, whichever&#xD;
             is later, in the previous study to the date of initiation of screening in the current&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dean Brostowin</last_name>
    <role>Study Director</role>
    <affiliation>Promentis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CNRI- Los Angeles</name>
      <address>
        <city>Pico Rivera</city>
        <state>California</state>
        <zip>90662</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute for Clinical Research</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Clinical Research</name>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch Atlanta</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Charles Clinical Trials</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrative Clinical Trials, LLC</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finger Lakes Clinical Research</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Insight Clinical Trials, LLC</name>
      <address>
        <city>Shaker Heights</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Research Company</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Clinical Trials, Inc</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <disposition_first_submitted>December 11, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>October 26, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 28, 2021</disposition_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Promentis Pharmaceuticals</keyword>
  <keyword>TTM</keyword>
  <keyword>SXC-2023</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trichotillomania</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03797521/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03797521/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03797521
org study id: PRO-201
nct id: NCT03797521
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to explore the safety, tolerability and activity of SXC-2023
      when dosed for 6 weeks versus placebo in adult patients with moderate to severe
      Trichotillomania.
This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study
      consisting of a screening period of up to 40 days, a 6 week randomized double-blind treatment
      period, followed by an up to 2 week safety follow-up period after the last dose of study
      medication.

      Patients will be randomized to one of four treatment groups. Patients will participate for a
      total of up to 10 weeks, including screening, the 6-week treatment period and follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind, Placebo-controlled Study
measure: Explore the incidence of treatment-emergent adverse events in adults with moderate to severe TTM
time frame: Up to 7 weeks
description: Safety and tolerability assessed using the frequency of subjects with serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication.
measure: Change from baseline hairpulling frequency and severity through 6 weeks
time frame: Up to 7 weeks
description: Improvement will be assessed using the different measurement parameters of all scales using scales such as the Massachusetts General Hospital Hairpulling scale (MGH-HPS)
measure: Change from baseline hairpulling frequency and severity through 6 weeks
time frame: Up to 7 weeks
description: Improvement will be assessed using the different measurement parameters of all scales using scales such as the Clinical Global Impression of Severity and Change (CGI-S/C)
measure: Change from baseline hairpulling frequency and severity through 6 weeks
time frame: Up to 7 weeks
description: Improvement will be assessed using the different measurement parameters of all scales using scales such as the Patient Global Impression of Status and Change (PGI-S/C)
measure: Change from baseline hairpulling frequency and severity daily through 6 weeks
time frame: Up to 7 weeks
description: Improvement will be assessed using the different measurement parameters of all scales using scales such as the Trichotillomania Symptom Diary (TSD)
measure: Preliminary psychometric evidence of the Trichotillomania Symptom Diary (TSD) will be assessed
time frame: Up to 7 weeks
description: The reliability, validity and responsiveness of the newly developed TSD assessment will be assessed at the item level.
arm group label: SXC-2023 50mg QD
arm group type: Experimental
description: SXC-2023 50mg dosed once daily for 6 weeks
arm group label: SXC-2023 200mg QD
arm group type: Experimental
description: SXC-2023 200mg dosed once daily for 6 weeks
arm group label: SXC-2023 800mg QD
arm group type: Experimental
description: SXC-2023 800mg dosed once daily for 6 weeks
arm group label: Matching Placebo QD
arm group type: Placebo Comparator
description: Matching Placebo dosed once daily for 6 weeks
intervention type: Drug
intervention name: SXC-2023
description: SXC-2023 oral capsules
arm group label: SXC-2023 200mg QD
arm group label: SXC-2023 50mg QD
arm group label: SXC-2023 800mg QD
intervention type: Drug
intervention name: Placebo
description: Matching Placebo oral capsules
arm group label: Matching Placebo QD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Dean Brostowin
role: Study Director
affiliation: Promentis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Trichotillomania
provided document: 
provided document: 