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/NCT05972044</url>
    </required_header>
    <id_info>
      <org_study_id>SOL-ADHD-301</org_study_id>
      <nct_id>NCT05972044</nct_id>
    </id_info>
    <brief_title>A Study to Access the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)</brief_title>
    <official_title>A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Axsome Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Axsome Therapeutics, 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>
        FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a&#xD;
        Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to&#xD;
        assess the efficacy and safety of solriamfetol in adults with ADHD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and&#xD;
        Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be&#xD;
        randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or&#xD;
        placebo, once daily for 6 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from Baseline to Week 6 in the AISRS total score</measure>
      <time_frame>6 weeks</time_frame>
      <description>Adult ADHD Investigator Symptom Report Scale (AISRS)</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">450</enrollment>
    <condition>ADHD</condition>
    <arm_group>
      <arm_group_label>Solriamfetol 150 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Up to 6 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Solriamfetol 300 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Up to 6 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Up to 6 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Solriamfetol 150 mg</intervention_name>
      <description>Solriamfetol tablets, taken once daily</description>
      <arm_group_label>Solriamfetol 150 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Solriamfetol 300 mg</intervention_name>
      <description>Solriamfetol tablets, taken once daily</description>
      <arm_group_label>Solriamfetol 300 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo tablets, taken once daily</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Primary diagnosis of ADHD according to DSM-5 criteria.&#xD;
  &#xD;
            -  Provides written informed consent to participate in the study before the conduct of&#xD;
               any study procedures.&#xD;
  &#xD;
            -  Male or female, aged 18 to 55 inclusive.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior exposure to solriamfetol/Sunosi, through either a clinical study or&#xD;
               prescription.&#xD;
  &#xD;
            -  Unable to comply with study procedures.&#xD;
  &#xD;
            -  Medically inappropriate for study participation in the opinion of the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Study Director</last_name>
      <phone>212-332-5061</phone>
      <email>cstreicher@axsome.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinical Research Site</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32801</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Research Site</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32806</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Research Site</name>
        <address>
          <city>Cherry Hill</city>
          <state>New Jersey</state>
          <zip>08002</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Research Site</name>
        <address>
          <city>Memphis</city>
          <state>Tennessee</state>
          <zip>38119</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Research Site</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Research Site</name>
        <address>
          <city>Draper</city>
          <state>Utah</state>
          <zip>84020</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.axsome.com</url>
      <description>Axsome Therapeutics Website</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Attention deficit hyperactivity disorder</keyword>
    <keyword>ADHD</keyword>
    <keyword>Solriamfetol</keyword>
    <keyword>Sunosi</keyword>
    <keyword>Axsome</keyword>
    <keyword>Non-stimulant therapy</keyword>
    <keyword>Dopamine norepinephrine reuptake inhibitor</keyword>
    <patient_data>
      <sharing_ipd>No</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/NCT05972044
  org study id: SOL-ADHD-301
  nct id: NCT05972044
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a
        Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to
        assess the efficacy and safety of solriamfetol in adults with ADHD.
  Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and
        Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be
        randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or
        placebo, once daily for 6 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Change from Baseline to Week 6 in the AISRS total score
  time frame: 6 weeks
  description: Adult ADHD Investigator Symptom Report Scale (AISRS)
  arm group label: Solriamfetol 150 mg
  arm group type: Experimental
  description: Up to 6 weeks
  arm group label: Solriamfetol 300 mg
  arm group type: Experimental
  description: Up to 6 weeks
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Up to 6 weeks
  intervention type: Drug
  intervention name: Solriamfetol 150 mg
  description: Solriamfetol tablets, taken once daily
  arm group label: Solriamfetol 150 mg
  intervention type: Drug
  intervention name: Solriamfetol 300 mg
  description: Solriamfetol tablets, taken once daily
  arm group label: Solriamfetol 300 mg
  intervention type: Drug
  intervention name: Placebo
  description: Placebo tablets, taken once daily
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Study Director
  phone: 212-332-5061
  email: cstreicher@axsome.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  url: http://www.axsome.com
  description: Axsome Therapeutics Website
  responsible party type: Sponsor
  sharing ipd: No