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/NCT05978258</url>
    </required_header>
    <id_info>
      <org_study_id>81829797</org_study_id>
      <nct_id>NCT05978258</nct_id>
    </id_info>
    <brief_title>A Close Examination of Patient Experiences in Cluster Headache Clinical Research</brief_title>
    <official_title>An Observational Study Assessing the Experience of Patients Undergoing Active Cluster Headache Clinical Trials</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Power Life Sciences Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Power Life Sciences Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Historically, participation in clinical studies is highly skewed towards particular&#xD;
        demographic groups of people.&#xD;
  &#xD;
        This research will invite several participants to gather a wide range of information on&#xD;
        clinical trial experiences for cluster headache patients. The aim of the study is to identify&#xD;
        the factors that limit the ability of a person to enroll in, as well as complete a clinical&#xD;
        trial for treatment of cluster headache.&#xD;
  &#xD;
        The data collected from this study will help improve future outcomes for all cluster headache&#xD;
        patients as well as those in under-represented demographic groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2024</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of patients who decide to enroll in a cluster headache clinical study.</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of cluster headache patients who remain in clinical research until completion.</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Cluster Headache</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with cluster headache who are actively considering enrolling in a clinical trial&#xD;
          for the said condition, but have not yet completed enrollment and randomization phases.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient has been diagnosed with cluster headache&#xD;
  &#xD;
            -  Patient has access to a home internet connection in order to provide regular updates&#xD;
               through the course of the study&#xD;
  &#xD;
            -  Participant must be 18 years of age or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient has an ECOG score of 4 or higher&#xD;
  &#xD;
            -  Patient is not able to provide consistent digital updates as per study requirements&#xD;
  &#xD;
            -  Patient does not complete or agree to terms outlined in the Informed Consent Form&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael B Gill</last_name>
      <role>Study Director</role>
      <affiliation>Power Life Sciences Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael B Gill</last_name>
      <phone>(415) 900-4227</phone>
      <email>bask@withpower.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Power Life Sciences</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94107</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael B Gill</last_name>
        <phone>415-900-4227</phone>
        <email>https://www.withpower.com/contact-us@withpower.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Merli E, Asioli GM, Favoni V, Zenesini C, Mascarella D, Sartori A, Cortelli P, Cevoli S, Pierangeli G. Great occipital nerve long-acting steroid injections in cluster headache therapy: an observational prospective study. J Neurol. 2022 Apr;269(4):2193-2199. doi: 10.1007/s00415-021-10884-0. Epub 2021 Nov 25.</citation>
      <PMID>34820736</PMID>
    </reference>
    <reference>
      <citation>Snoer A, Lund N, Beske R, Hagedorn A, Jensen RH, Barloese M. Cluster headache beyond the pain phase: A prospective study of 500 attacks. Neurology. 2018 Aug 28;91(9):e822-e831. doi: 10.1212/01.wnl.0000542491.92981.03. Epub 2018 Jul 27.</citation>
      <PMID>30054443</PMID>
    </reference>
    <reference>
      <citation>Vigano A, Savastano E, Petolicchio B, Toscano M, De Sanctis R, Maestrini I, Di Piero V. A Study of Clinical Features and Risk Factors of Self-Referring Emergency Department Headache Patients: A Comparison with Headache Center Outpatients. Eur Neurol. 2020;83(1):34-40. doi: 10.1159/000505915. Epub 2020 Mar 10.</citation>
      <PMID>32155625</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cluster Headache</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cluster Headache</mesh_term>
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 28, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT05978258/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05978258
  org study id: 81829797
  nct id: NCT05978258
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Historically, participation in clinical studies is highly skewed towards particular
        demographic groups of people.
  
        This research will invite several participants to gather a wide range of information on
        clinical trial experiences for cluster headache patients. The aim of the study is to identify
        the factors that limit the ability of a person to enroll in, as well as complete a clinical
        trial for treatment of cluster headache.
  
        The data collected from this study will help improve future outcomes for all cluster headache
        patients as well as those in under-represented demographic groups.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Rate of patients who decide to enroll in a cluster headache clinical study.
  time frame: 3 months
  measure: Number of cluster headache patients who remain in clinical research until completion.
  time frame: 12 months
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael B Gill
  role: Study Director
  affiliation: Power Life Sciences Inc.
  last name: Michael B Gill
  phone: (415) 900-4227
  email: bask@withpower.com
  facility: 
  contact: 
  country: United States
  citation: Merli E, Asioli GM, Favoni V, Zenesini C, Mascarella D, Sartori A, Cortelli P, Cevoli S, Pierangeli G. Great occipital nerve long-acting steroid injections in cluster headache therapy: an observational prospective study. J Neurol. 2022 Apr;269(4):2193-2199. doi: 10.1007/s00415-021-10884-0. Epub 2021 Nov 25.
  PMID: 34820736
  citation: Snoer A, Lund N, Beske R, Hagedorn A, Jensen RH, Barloese M. Cluster headache beyond the pain phase: A prospective study of 500 attacks. Neurology. 2018 Aug 28;91(9):e822-e831. doi: 10.1212/01.wnl.0000542491.92981.03. Epub 2018 Jul 27.
  PMID: 30054443
  citation: Vigano A, Savastano E, Petolicchio B, Toscano M, De Sanctis R, Maestrini I, Di Piero V. A Study of Clinical Features and Risk Factors of Self-Referring Emergency Department Headache Patients: A Comparison with Headache Center Outpatients. Eur Neurol. 2020;83(1):34-40. doi: 10.1159/000505915. Epub 2020 Mar 10.
  PMID: 32155625
  responsible party type: Sponsor
  mesh term: Cluster Headache
  mesh term: Headache
  sharing ipd: Undecided
  provided document: 