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/NCT06016465</url>
    </required_header>
    <id_info>
      <org_study_id>E23081</org_study_id>
      <nct_id>NCT06016465</nct_id>
    </id_info>
    <brief_title>Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?</brief_title>
    <official_title>Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Texas Tech University Health Sciences Center, El Paso</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Texas Tech University Health Sciences Center, El Paso</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        For some patients who come to the emergency department for treatment of a migraine headache,&#xD;
        peripheral headache nerve blocks (PHNB) have proven to be an efficient and effective&#xD;
        treatment for headache relief. Previous studies have demonstrated that adding steroids as an&#xD;
        adjunct treatment to standard migraine treatment can reduce recurrence of headaches in the&#xD;
        subsequent few days.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Previous studies have provided evidence that administering steroids in addition to standard&#xD;
        migraine headache treatment in the emergency department may reduce the recurrence of the&#xD;
        headache within 24-72 hours. The standard migraine treatments in previous studies have been&#xD;
        varied and include 5-HT receptor agonists, dopamine antagonists, dihydroergotamine, NSAIDS,&#xD;
        and opioid analgesics. The steroids added to the standard treatment have been prednisone and&#xD;
        dexamethasone (both IV and oral).&#xD;
  &#xD;
        This is the first study to examine the combination of peripheral nerve block as the primary&#xD;
        treatment of migraine followed by oral dexamethasone to prevent recurrence.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">September 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <phase>Early Phase 1</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>
      <intervention_model_description>Randomized 1:1 for study drug vs placebo</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>study drug pills (dexamethasone or placebo) will be placed in identical colored capsules and then into numbered packets. Only pharmacist will be unblinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Recurrence of headache</measure>
      <time_frame>72-96 hours post treatment</time_frame>
      <description>Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Early recurrence headache and timing</measure>
      <time_frame>72-96hrs post treatment</time_frame>
      <description>HA severity, location, time since enrollment enrollment,medications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>side effects of dexamethasone identified if any</measure>
      <time_frame>72-96 hrs post treatment</time_frame>
      <description>elevation in glucose level, other symptoms associated with corticosteroids</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">84</enrollment>
    <condition>Migraine</condition>
    <arm_group>
      <arm_group_label>Dexamethasone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>single oral dose of dexamethasone (8mg)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Single oral dose of placebo pill</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone Oral</intervention_name>
      <description>Two 4mg pills</description>
      <arm_group_label>Dexamethasone</arm_group_label>
      <other_name>Decadron</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>2 placebo pills</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>Dextrose methyl cellulose</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Meet ICHD-3 Migraine Headache Criteria&#xD;
  &#xD;
            -  Had a minimum 5-point reduction in headache intensity after nerve block(s) or post-&#xD;
               block pain score of 0 to 2&#xD;
  &#xD;
            -  Nerve block performed with bupivacaine 0.5%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Head trauma&#xD;
  &#xD;
            -  Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)&#xD;
  &#xD;
            -  Headache in the setting of viral syndrome&#xD;
  &#xD;
            -  Chronically on steroids&#xD;
  &#xD;
            -  Known allergy to dexamethasone&#xD;
  &#xD;
            -  Unable to reach the patient by phone or text for follow-up&#xD;
  &#xD;
            -  Gestational diabetes or other uncontrolled diabetes&#xD;
  &#xD;
            -  Known to be immunocompromised&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Susan Watts, PhD.</last_name>
      <role>Study Director</role>
      <affiliation>Texas Tech University Health Sciences Center, Department of Emergency Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Edward Michelson, MD</last_name>
      <phone>915 215 4600</phone>
      <email>edward.michelson@ttuhsc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Medical Center of El Paso</name>
        <address>
          <city>El Paso</city>
          <state>Texas</state>
          <zip>79905</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Leann Rodriguez</last_name>
        <phone>915-215-4976</phone>
        <email>rod72863@ttuhsc.edu</email>
      </contact>
      <investigator>
        <last_name>Edward A Michelson, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Texas Tech University Health Sciences Center, El Paso</investigator_affiliation>
      <investigator_full_name>Edward Michelson, MD</investigator_full_name>
      <investigator_title>Professor and Chair Dept of Emergency Medicine</investigator_title>
    </responsible_party>
    <keyword>migraine headache</keyword>
    <keyword>peripheral nerve block</keyword>
    <keyword>dexamethasone</keyword>
    <keyword>steroid treatment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Recurrence</mesh_term>
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
    </intervention_browse>
    <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/NCT06016465
  org study id: E23081
  nct id: NCT06016465
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  For some patients who come to the emergency department for treatment of a migraine headache,
        peripheral headache nerve blocks (PHNB) have proven to be an efficient and effective
        treatment for headache relief. Previous studies have demonstrated that adding steroids as an
        adjunct treatment to standard migraine treatment can reduce recurrence of headaches in the
        subsequent few days.
  Previous studies have provided evidence that administering steroids in addition to standard
        migraine headache treatment in the emergency department may reduce the recurrence of the
        headache within 24-72 hours. The standard migraine treatments in previous studies have been
        varied and include 5-HT receptor agonists, dopamine antagonists, dihydroergotamine, NSAIDS,
        and opioid analgesics. The steroids added to the standard treatment have been prednisone and
        dexamethasone (both IV and oral).
  
        This is the first study to examine the combination of peripheral nerve block as the primary
        treatment of migraine followed by oral dexamethasone to prevent recurrence.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized 1:1 for study drug vs placebo
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: study drug pills (dexamethasone or placebo) will be placed in identical colored capsules and then into numbered packets. Only pharmacist will be unblinded.
  measure: Recurrence of headache
  time frame: 72-96 hours post treatment
  description: Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred
  measure: Early recurrence headache and timing
  time frame: 72-96hrs post treatment
  description: HA severity, location, time since enrollment enrollment,medications
  measure: side effects of dexamethasone identified if any
  time frame: 72-96 hrs post treatment
  description: elevation in glucose level, other symptoms associated with corticosteroids
  arm group label: Dexamethasone
  arm group type: Experimental
  description: single oral dose of dexamethasone (8mg)
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Single oral dose of placebo pill
  intervention type: Drug
  intervention name: Dexamethasone Oral
  description: Two 4mg pills
  arm group label: Dexamethasone
  other name: Decadron
  intervention type: Drug
  intervention name: Placebo
  description: 2 placebo pills
  arm group label: Placebo
  other name: Dextrose methyl cellulose
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Susan Watts, PhD.
  role: Study Director
  affiliation: Texas Tech University Health Sciences Center, Department of Emergency Medicine
  last name: Edward Michelson, MD
  phone: 915 215 4600
  email: edward.michelson@ttuhsc.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Texas Tech University Health Sciences Center, El Paso
  investigator full name: Edward Michelson, MD
  investigator title: Professor and Chair Dept of Emergency Medicine
  mesh term: Recurrence
  mesh term: Headache
  mesh term: Dexamethasone
  sharing ipd: No