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/NCT06034886</url>
    </required_header>
    <id_info>
      <org_study_id>BHV4157-SCA-EAP</org_study_id>
      <nct_id>NCT06034886</nct_id>
    </id_info>
    <brief_title>Troriluzole Individual Patient IND Expanded Access Program</brief_title>
    <official_title>Expanded Access Use of Troriluzole for Spinocerebellar Ataxia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Biohaven Pharmaceuticals, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Biohaven Pharmaceuticals, Inc.</source>
    <brief_summary>
      <textblock>
        This is an expanded access program to provide troriuzole for treatment of spinocerebellar&#xD;
        ataxia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This expanded access program is designed to provide access to troriluzole for patients with&#xD;
        spinocerebellar ataxia who are not eligible for other troriluzole clinical trials, and who in&#xD;
        the opinion of the treating physician would potentially benefit from treatment with&#xD;
        troriluzole.&#xD;
  &#xD;
        Requests by treating physicians to file a single patient investigational new drug application&#xD;
        as part of the expanded access program for troriluzole will be considered on a case-by-case&#xD;
        basis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Available</overall_status>
    <study_type>Expanded Access</study_type>
    <has_expanded_access>No</has_expanded_access>
    <expanded_access_info>
      <expanded_access_type_individual>Yes</expanded_access_type_individual>
    </expanded_access_info>
    <condition>SCA</condition>
    <condition>Spinocerebellar Ataxias</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Troriluzole</intervention_name>
      <other_name>BHV-4157</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient has confirmed diagnosis of spinocerebellar ataxia (SCA)&#xD;
  &#xD;
            -  In the opinion and clinical judgement of the Physician, potential benefit outweighs&#xD;
               potential risk of receiving an investigational therapy, based on the individual&#xD;
               patient's medical history and program eligibility criteria and judged by the treating&#xD;
               physician to be medically suitable for treatment with troriluzole.&#xD;
  &#xD;
            -  Adequate hepatic function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient is known to have acute or chronic liver disease that is clinically significant&#xD;
               in the Physician's judgment&#xD;
  &#xD;
            -  Patient has a history of a clinically significant medical condition that would&#xD;
               interfere with the patient's ability to comply with the expanded access treatment&#xD;
               instructions or would place the patient at increased risk&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Early Access Care</last_name>
      <phone>1-203-441-7938</phone>
      <phone_ext>170</phone_ext>
      <email>Troriluzole.SPIND@earlyaccesscare.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Ataxia</mesh_term>
      <mesh_term>Spinocerebellar Ataxias</mesh_term>
      <mesh_term>Spinocerebellar Degenerations</mesh_term>
    </condition_browse>
    <!-- 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/NCT06034886
  org study id: BHV4157-SCA-EAP
  nct id: NCT06034886
  lead sponsor: 
  This is an expanded access program to provide troriuzole for treatment of spinocerebellar
        ataxia.
  This expanded access program is designed to provide access to troriluzole for patients with
        spinocerebellar ataxia who are not eligible for other troriluzole clinical trials, and who in
        the opinion of the treating physician would potentially benefit from treatment with
        troriluzole.
  
        Requests by treating physicians to file a single patient investigational new drug application
        as part of the expanded access program for troriluzole will be considered on a case-by-case
        basis.
  expanded access type individual: Yes
  intervention type: Drug
  intervention name: Troriluzole
  other name: BHV-4157
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Early Access Care
  phone: 1-203-441-7938
  phone ext: 170
  email: Troriluzole.SPIND@earlyaccesscare.com
  responsible party type: Sponsor
  mesh term: Ataxia
  mesh term: Spinocerebellar Ataxias
  mesh term: Spinocerebellar Degenerations