<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/NCT03269435</url>
  </required_header>
  <id_info>
    <org_study_id>2017-8249</org_study_id>
    <nct_id>NCT03269435</nct_id>
  </id_info>
  <brief_title>Greater Occipital Nerve Block Versus Metoclopramide</brief_title>
  <official_title>A Randomized Trial of Greater Occipital Nerve Block With Bupivacaine Versus Intravenous Metoclopramide for Acute Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      We are comparing a type of nerve block called greater occipital nerve block versus standard&#xD;
      therapy among patients who present to an emergency department for acute migraine. This is a&#xD;
      randomized, double-blind, double dummy study. The greater occipital nerve block will be&#xD;
      performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">March 21, 2020</completion_date>
  <primary_completion_date type="Actual">March 21, 2020</primary_completion_date>
  <phase>Phase 4</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>
    <masking_description>Double dummy design with IV placebo and placebo nerve block</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>0-10 Pain Score</measure>
    <time_frame>one hour</time_frame>
    <description>Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sustained Headache Relief</measure>
    <time_frame>48 hours</time_frame>
    <description>Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained Headache Freedom</measure>
    <time_frame>48 hours</time_frame>
    <description>Headache = none, achieved in emergency department and maintained for 48 hours</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Greater Occipital Nerve Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral greater occipital nerve block with bupivacaine 0.5%&#xD;
+ Normal saline IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metoclopramide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Metoclopramide 10mg IV&#xD;
+ Bilateral greater occipital nerve block with normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Greater occipital nerve block with bupivacaine</intervention_name>
    <description>This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally</description>
    <arm_group_label>Greater Occipital Nerve Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoclopramide</intervention_name>
    <description>Metoclopramide 10mg IV will be administered over 15 minutes</description>
    <arm_group_label>Metoclopramide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible patients are adults who present with an acute moderate or severe headache meeting&#xD;
        migraine headache criteria, as defined by the International Classification of Headache&#xD;
        Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine&#xD;
        without Aura (1.5.1) will also be included, provided they have had at least one similar&#xD;
        attack previously.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if informed consent cannot be obtained, if there is concern for a&#xD;
        secondary cause of headache, if the maximum documented temperature is greater than 100.3&#xD;
        degrees, for a new objective neurologic abnormality, skull defect, suspected infection&#xD;
        overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents&#xD;
        including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins,&#xD;
        warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior&#xD;
        treatment with a greater occipital nerve block, allergy to the investigational medications,&#xD;
        pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of&#xD;
        anti-rejection transplant medications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>self-described</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <results_first_submitted>July 13, 2021</results_first_submitted>
  <results_first_submitted_qc>August 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 22, 2021</results_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Benjamin W. Friedman, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metoclopramide</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03269435/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Greater Occipital Nerve Block</title>
          <description>Bilateral greater occipital nerve block with bupivacaine 0.5%&#xD;
+ Normal saline IV&#xD;
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally</description>
        </group>
        <group group_id="P2">
          <title>Metoclopramide</title>
          <description>Metoclopramide 10mg IV&#xD;
+ Bilateral greater occipital nerve block with normal saline&#xD;
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Greater Occipital Nerve Block</title>
          <description>Bilateral greater occipital nerve block with bupivacaine 0.5%&#xD;
+ Normal saline IV&#xD;
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally</description>
        </group>
        <group group_id="B2">
          <title>Metoclopramide</title>
          <description>Metoclopramide 10mg IV&#xD;
+ Bilateral greater occipital nerve block with normal saline&#xD;
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="51"/>
            <count group_id="B2" value="48"/>
            <count group_id="B3" value="99"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="48"/>
                    <count group_id="B3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39" spread="11"/>
                    <measurement group_id="B2" value="38" spread="11"/>
                    <measurement group_id="B3" value="39" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="48"/>
                    <count group_id="B3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="48"/>
                    <count group_id="B3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline pain intensity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Severe pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="48"/>
                    <count group_id="B3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="48"/>
                    <count group_id="B3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>0-10 Pain Score</title>
        <description>Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour</description>
        <time_frame>one hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Greater Occipital Nerve Block</title>
            <description>Bilateral greater occipital nerve block with bupivacaine 0.5%&#xD;
+ Normal saline IV&#xD;
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally</description>
          </group>
          <group group_id="O2">
            <title>Metoclopramide</title>
            <description>Metoclopramide 10mg IV&#xD;
+ Bilateral greater occipital nerve block with normal saline&#xD;
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>0-10 Pain Score</title>
          <description>Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="4.1" upper_limit="5.8"/>
                    <measurement group_id="O2" value="6.1" lower_limit="5.2" upper_limit="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sustained Headache Relief</title>
        <description>Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication</description>
        <time_frame>48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Greater Occipital Nerve Block</title>
            <description>Bilateral greater occipital nerve block with bupivacaine 0.5%&#xD;
+ Normal saline IV&#xD;
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally</description>
          </group>
          <group group_id="O2">
            <title>Metoclopramide</title>
            <description>Metoclopramide 10mg IV&#xD;
+ Bilateral greater occipital nerve block with normal saline&#xD;
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Headache Relief</title>
          <description>Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sustained Headache Freedom</title>
        <description>Headache = none, achieved in emergency department and maintained for 48 hours</description>
        <time_frame>48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Greater Occipital Nerve Block</title>
            <description>Bilateral greater occipital nerve block with bupivacaine 0.5%&#xD;
+ Normal saline IV&#xD;
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally</description>
          </group>
          <group group_id="O2">
            <title>Metoclopramide</title>
            <description>Metoclopramide 10mg IV&#xD;
+ Bilateral greater occipital nerve block with normal saline&#xD;
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Headache Freedom</title>
          <description>Headache = none, achieved in emergency department and maintained for 48 hours</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>48 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Greater Occipital Nerve Block</title>
          <description>Bilateral greater occipital nerve block with bupivacaine 0.5%&#xD;
+ Normal saline IV&#xD;
Greater occipital nerve block with bupivacaine: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally</description>
        </group>
        <group group_id="E2">
          <title>Metoclopramide</title>
          <description>Metoclopramide 10mg IV&#xD;
+ Bilateral greater occipital nerve block with normal saline&#xD;
Metoclopramide: Metoclopramide 10mg IV will be administered over 15 minutes</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal symptoms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>head numbness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Various</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>drowsiness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Benjamin Friedman</name_or_title>
      <organization>Montefiore</organization>
      <phone>718-920-6626</phone>
      <email>befriedm@montefiore.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03269435
org study id: 2017-8249
nct id: NCT03269435
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
We are comparing a type of nerve block called greater occipital nerve block versus standard
      therapy among patients who present to an emergency department for acute migraine. This is a
      randomized, double-blind, double dummy study. The greater occipital nerve block will be
      performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double dummy design with IV placebo and placebo nerve block
measure: 0-10 Pain Score
time frame: one hour
description: Pain score assessed at baseline and one hour. 0= no pain, 10 = worst imaginable. This outcome is the change in pain between baseline and one hour
measure: Sustained Headache Relief
time frame: 48 hours
description: Headache level = mild or none. Achieved in emergency department and maintained for 48 hours without rescue medication
measure: Sustained Headache Freedom
time frame: 48 hours
description: Headache = none, achieved in emergency department and maintained for 48 hours
arm group label: Greater Occipital Nerve Block
arm group type: Experimental
description: Bilateral greater occipital nerve block with bupivacaine 0.5%
+ Normal saline IV
arm group label: Metoclopramide
arm group type: Active Comparator
description: Metoclopramide 10mg IV
+ Bilateral greater occipital nerve block with normal saline
intervention type: Procedure
intervention name: Greater occipital nerve block with bupivacaine
description: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
arm group label: Greater Occipital Nerve Block
intervention type: Drug
intervention name: Metoclopramide
description: Metoclopramide 10mg IV will be administered over 15 minutes
arm group label: Metoclopramide
criteria: 
gender: All
gender based: Yes
gender description: self-described
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Benjamin W. Friedman, MD
investigator title: Professor
mesh term: Migraine Disorders
mesh term: Metoclopramide
mesh term: Bupivacaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 