<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/NCT04432155</url>
  </required_header>
  <id_info>
    <org_study_id>NBTX-002</org_study_id>
    <nct_id>NCT04432155</nct_id>
  </id_info>
  <brief_title>Xenon Inhalation for Treatment of Panic Disorder</brief_title>
  <official_title>A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Panic Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nobilis Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nobilis 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>
      This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel&#xD;
      groups in patients with panic disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2021</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2021</primary_completion_date>
  <phase>Phase 2/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>PDSS</measure>
    <time_frame>Baseline to Week 6</time_frame>
    <description>Panic Disorder Severity Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PHQ-9</measure>
    <time_frame>Baseline to Week 6</time_frame>
    <description>Patient Health Questionnaire-9</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Panic Disorder</condition>
  <arm_group>
    <arm_group_label>NBTX-001</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination Product: NBTX-001 Xenon Inhaler The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Combination Product: Placebo The placebo medical gas consists of 30% oxygen and 70% nitrogen. The dose of placebo medical gas is 10 L by volume.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xenon</intervention_name>
    <description>30% xenon, 30% oxygen, and 40% nitrogen</description>
    <arm_group_label>NBTX-001</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>30% oxygen, and 70% nitrogen</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis of panic disorder according to DSM-5.&#xD;
&#xD;
          -  Male and female patients ≥18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of schizophrenia, bipolar and other psychotic disorders.&#xD;
&#xD;
          -  Patients with underlying pulmonary disease, chronic obstructive pulmonary disease&#xD;
             (COPD), asthma, severe lung disease and/or baseline oxygen saturations &lt;92% or any&#xD;
             other respiratory conditions / diseases that may affect the respiratory function.&#xD;
&#xD;
          -  Currently undergoing targeted empirically-driven psychotherapy for panic disorder or&#xD;
             panic disorder-related symptoms.&#xD;
&#xD;
          -  Currently undergoing exposure-based psychotherapy for any condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Panic Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Xenon</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04432155
org study id: NBTX-002
nct id: NCT04432155
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel
      groups in patients with panic disorder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: PDSS
time frame: Baseline to Week 6
description: Panic Disorder Severity Scale
measure: PHQ-9
time frame: Baseline to Week 6
description: Patient Health Questionnaire-9
arm group label: NBTX-001
arm group type: Experimental
description: Combination Product: NBTX-001 Xenon Inhaler The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.
arm group label: Placebo
arm group type: Placebo Comparator
description: Combination Product: Placebo The placebo medical gas consists of 30% oxygen and 70% nitrogen. The dose of placebo medical gas is 10 L by volume.
intervention type: Drug
intervention name: Xenon
description: 30% xenon, 30% oxygen, and 40% nitrogen
arm group label: NBTX-001
intervention type: Drug
intervention name: Placebo
description: 30% oxygen, and 70% nitrogen
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Panic Disorder
mesh term: Xenon
sharing ipd: Undecided