<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/NCT03282227</url>
  </required_header>
  <id_info>
    <org_study_id>CP-2017-001</org_study_id>
    <nct_id>NCT03282227</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine</brief_title>
  <acronym>ADAM</acronym>
  <official_title>A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zosano Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zosano Pharma Corporation</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 is an open-label, twelve-month safety study. There is a screening period followed by a&#xD;
      run-in period to record migraine activity. Qualified subjects will receive study medication&#xD;
      for up to twelve months for the treatment of multiple migraine attacks. Using the electronic&#xD;
      diary (eDiary) to confirm they are experiencing a qualified migraine, subjects will&#xD;
      self-administer the patches and respond to questions in the eDiary post treatment&#xD;
      administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, twelve-month safety study. There is a screening period followed by a&#xD;
      run-in period (14 to 21 days) to determine eligibility for treatment with study medication&#xD;
      based on daily eDiary data collection. Qualified subjects will receive study medication on&#xD;
      Day 1 for up to twelve months for the treatment of migraine headaches. Migraines will be&#xD;
      treated with a single dose, consisting of two patches, but subjects can treat multiple&#xD;
      migraine attacks throughout the 12 months. Using the eDiary to confirm they are experiencing&#xD;
      a qualified migraine, subjects will self-administer the patches and continue to respond to&#xD;
      questions in the eDiary for 48 hours post treatment administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single dose, open-label treatment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open-label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Number and % of subjects in safety population with any treatment-emergent adverse event(s) during the study. TEAE is defined as any new adverse event (AE) that started after first patch application. This was an open-label study with no control group. No statistical analyses were performed. Application site skin reactions including erythema, swelling, haemorrhage, bruise, pain, and pruritus were collected systematically via subject e-diary and/or investigator skin assessment at study visits. All other AEs were spontaneously reported by subject or observed upon examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose</measure>
    <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
    <description>Percentage of migraine attacks for which pain freedom defined as a pain level of 'None' (Grade 0 on pain severity scale where 0: None, 1: Mild, 2: Moderate, 3: Severe, and lower values represent a better outcome) was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose</measure>
    <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
    <description>Percentage of migraine attacks for which freedom from most bothersome symptom other than pain defined as an absence of the most bothersome symptom was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose</measure>
    <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
    <description>Percentage of migraine attacks for which pain relief defined as an improvement of pain severity (1) to mild (Grade 1) or none (Grade 0) from moderate (Grade 2) or severe (Grade 3) at baseline, or (2) an improvement of pain severity to none (Grade 0) from mild (Grade 1) at baseline, without rescue medication was achieved. Pain severity scale has grades: 0: None, 1: Mild, 2: Moderate, 3: Severe, where lower values represent a better outcome. This was an open-label study with no control group. No statistical analyses were performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose</measure>
    <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
    <description>Percentage of subjects for which nausea freedom defined as absence of nausea and/or vomiting without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose</measure>
    <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
    <description>Percentage of migraine attacks for which photophobia freedom defined as an absence of photophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose</measure>
    <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
    <description>Percentage of migraine attacks for which phonophobia freedom defined as an absence of phonophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">342</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>M207 Microneedle System 3.8 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>M207 Microneedle System</intervention_name>
    <description>M207 Microneedle System 3.8 mg</description>
    <arm_group_label>M207 Microneedle System 3.8 mg</arm_group_label>
    <other_name>ZP-Zolmitriptan Intracutaneous Microneedle System</other_name>
    <other_name>ADAM-Zolmitriptan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          1. Women or men 18 to 75 years of age&#xD;
&#xD;
          2. Greater than 1 year history of episodic, migraine (with or without aura) with onset&#xD;
             prior to 50 years of age.&#xD;
&#xD;
          3. Migraine history during the prior 6 months must include:&#xD;
&#xD;
               1. at least 2 migraines per month&#xD;
&#xD;
               2. no more than 8 migraines per month&#xD;
&#xD;
               3. no more than 15 headache days per month&#xD;
&#xD;
          4. Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy&#xD;
             and use an acceptable double-barrier method of birth control during the trial.&#xD;
&#xD;
          5. Willing and able to treat a minimum of 2 migraines per month with study medication and&#xD;
             consistently complete eDiary for up to 12 months.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication to triptans&#xD;
&#xD;
          2. Use of selective serotonin reuptake inhibitors (drugs like Prozac®) or serotonin or&#xD;
             norepinephrine reuptake inhibitors (drugs like Effexor®) or anti-coagulants (drugs&#xD;
             like Coumadin®)&#xD;
&#xD;
          3. Known allergy or sensitivity to zolmitriptan or its derivatives or formulations&#xD;
&#xD;
          4. Known allergy or sensitivity to adhesives and/or titanium&#xD;
&#xD;
          5. Women who are pregnant, breast-feeding or plan a pregnancy during this study&#xD;
&#xD;
          6. Three or more of the following cardiovascular risk factors:&#xD;
&#xD;
               -  Current tobacco use&#xD;
&#xD;
               -  Hypertension or receiving anti-hypertensive medication for hypertension&#xD;
&#xD;
               -  Hyperlipidemia or on prescribed anti-cholesterol treatment&#xD;
&#xD;
               -  Family history of premature coronary artery disease&#xD;
&#xD;
               -  Diabetes mellitus&#xD;
&#xD;
          7. History or current abuse or dependence on alcohol or drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Don Kellerman, Pharm.D.</last_name>
    <role>Study Director</role>
    <affiliation>Zosano Pharma Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Achieve Clinical Research</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Downtown L.A. Research Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Asthma Associates of Santa Clara Valley Research Center</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Medical Clinic for Headache</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Empire Clinical Research</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Allergy Asthma Centers</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harmony Medical Research Institute</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DelRicht Research</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Clinical Trials</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedVadis Research Corporation</name>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>02472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Headache and Neurological Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <zip>55441</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>StudyMetrix Research LLC</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63303-3041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinvest Research</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albuquerque Clinical Trials</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Clinical Research</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peters Medical Research</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Clinical Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raleigh Medical Group PMG Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lillestol Research</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Care Associates/Radiant Research</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Neurology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center - Neurology Clinic</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Health Research</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <results_first_submitted>July 20, 2020</results_first_submitted>
  <results_first_submitted_qc>August 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 19, 2020</results_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>migraine</keyword>
  <keyword>migraine headache</keyword>
  <keyword>acute migraine</keyword>
  <keyword>acute migraine headache</keyword>
  <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>Oxazolidinones</mesh_term>
    <mesh_term>Zolmitriptan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03282227/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03282227/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>M207 Microneedle System 3.8 mg</title>
          <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="342"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed at Least 6 Months</title>
              <participants_list>
                <participants group_id="P1" count="257"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="215"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Exposure Goals Achieved</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance w/ protocol requirements</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included 335 subjects (98.0%) who received any amount of study drug (applied at least 1 patch).</population>
      <group_list>
        <group group_id="B1">
          <title>M207 Microneedle System 3.8 mg</title>
          <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="335"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.9" spread="12.07"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="297"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="275"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="265"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="165.20" spread="8.602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79.76" spread="20.847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.19" spread="7.185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months</title>
        <description>Number and % of subjects in safety population with any treatment-emergent adverse event(s) during the study. TEAE is defined as any new adverse event (AE) that started after first patch application. This was an open-label study with no control group. No statistical analyses were performed. Application site skin reactions including erythema, swelling, haemorrhage, bruise, pain, and pruritus were collected systematically via subject e-diary and/or investigator skin assessment at study visits. All other AEs were spontaneously reported by subject or observed upon examination.</description>
        <time_frame>0 to 12 months</time_frame>
        <population>Safety Population included 335 subjects (98.0%) who received any amount of study drug (applied at least 1 patch).</population>
        <group_list>
          <group group_id="O1">
            <title>M207 Microneedle System 3.8 mg</title>
            <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months</title>
          <description>Number and % of subjects in safety population with any treatment-emergent adverse event(s) during the study. TEAE is defined as any new adverse event (AE) that started after first patch application. This was an open-label study with no control group. No statistical analyses were performed. Application site skin reactions including erythema, swelling, haemorrhage, bruise, pain, and pruritus were collected systematically via subject e-diary and/or investigator skin assessment at study visits. All other AEs were spontaneously reported by subject or observed upon examination.</description>
          <population>Safety Population included 335 subjects (98.0%) who received any amount of study drug (applied at least 1 patch).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="335"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose</title>
        <description>Percentage of migraine attacks for which pain freedom defined as a pain level of 'None' (Grade 0 on pain severity scale where 0: None, 1: Mild, 2: Moderate, 3: Severe, and lower values represent a better outcome) was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.</description>
        <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
        <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>M207 Microneedle System 3.8 mg</title>
            <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose</title>
          <description>Percentage of migraine attacks for which pain freedom defined as a pain level of 'None' (Grade 0 on pain severity scale where 0: None, 1: Mild, 2: Moderate, 3: Severe, and lower values represent a better outcome) was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.</description>
          <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
          <units>Qualifying migraines with 2 hour data</units>
          <param>Count of Units</param>
          <units_analyzed>Qualifying migraines with 2 hour data</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="335"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Qualifying migraines with 2 hour data</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5617"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2477"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose</title>
        <description>Percentage of migraine attacks for which freedom from most bothersome symptom other than pain defined as an absence of the most bothersome symptom was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.</description>
        <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
        <population>Modified Intent-to-Treat Population included all subjects who received</population>
        <group_list>
          <group group_id="O1">
            <title>M207 Microneedle System 3.8 mg</title>
            <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose</title>
          <description>Percentage of migraine attacks for which freedom from most bothersome symptom other than pain defined as an absence of the most bothersome symptom was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.</description>
          <population>Modified Intent-to-Treat Population included all subjects who received</population>
          <units>Qualifying migraines with 2 hr data</units>
          <param>Count of Units</param>
          <units_analyzed>Qualifying migraines with 2 hr data</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="335"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Qualifying migraines with 2 hr data</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5330"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3315"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose</title>
        <description>Percentage of migraine attacks for which pain relief defined as an improvement of pain severity (1) to mild (Grade 1) or none (Grade 0) from moderate (Grade 2) or severe (Grade 3) at baseline, or (2) an improvement of pain severity to none (Grade 0) from mild (Grade 1) at baseline, without rescue medication was achieved. Pain severity scale has grades: 0: None, 1: Mild, 2: Moderate, 3: Severe, where lower values represent a better outcome. This was an open-label study with no control group. No statistical analyses were performed.</description>
        <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
        <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>M207 Microneedle System 3.8 mg</title>
            <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose</title>
          <description>Percentage of migraine attacks for which pain relief defined as an improvement of pain severity (1) to mild (Grade 1) or none (Grade 0) from moderate (Grade 2) or severe (Grade 3) at baseline, or (2) an improvement of pain severity to none (Grade 0) from mild (Grade 1) at baseline, without rescue medication was achieved. Pain severity scale has grades: 0: None, 1: Mild, 2: Moderate, 3: Severe, where lower values represent a better outcome. This was an open-label study with no control group. No statistical analyses were performed.</description>
          <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
          <units>Qualifying migraines with 2 hr data</units>
          <param>Count of Units</param>
          <units_analyzed>Qualifying migraines with 2 hr data</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="335"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Qualifying migraines with 2 hr data</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5617"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4552"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose</title>
        <description>Percentage of subjects for which nausea freedom defined as absence of nausea and/or vomiting without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.</description>
        <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
        <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>M207 Microneedle System 3.8 mg</title>
            <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose</title>
          <description>Percentage of subjects for which nausea freedom defined as absence of nausea and/or vomiting without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.</description>
          <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
          <units>Qualifying migraines with 2 hr data</units>
          <param>Count of Units</param>
          <units_analyzed>Qualifying migraines with 2 hr data</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="335"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Qualifying migraines with 2 hr data</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5617"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose</title>
        <description>Percentage of migraine attacks for which photophobia freedom defined as an absence of photophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.</description>
        <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
        <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>M207 Microneedle System 3.8 mg</title>
            <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose</title>
          <description>Percentage of migraine attacks for which photophobia freedom defined as an absence of photophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.</description>
          <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
          <units>Qualifying migraines with 2 hour data</units>
          <param>Count of Units</param>
          <units_analyzed>Qualifying migraines with 2 hour data</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="335"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Qualifying migraines with 2 hour data</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5617"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose</title>
        <description>Percentage of migraine attacks for which phonophobia freedom defined as an absence of phonophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.</description>
        <time_frame>2 hours for each Migraine, up to 12 months for each subject</time_frame>
        <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>M207 Microneedle System 3.8 mg</title>
            <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose</title>
          <description>Percentage of migraine attacks for which phonophobia freedom defined as an absence of phonophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.</description>
          <population>Modified intent-to-treat (mITT) Population included all subjects who received any amount of study drug to treat a qualifying migraine, and who had efficacy data.</population>
          <units>Qualifying migraines with 2 hour data</units>
          <param>Count of Units</param>
          <units_analyzed>Qualifying migraines with 2 hour data</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="335"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Qualifying migraines with 2 hour data</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5617"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>0-12 months</time_frame>
      <desc>Application site skin reactions including erythema, swelling, haemorrhage, bruise, pain, and pruritus were collected systematically via subject e-diary and/or investigator skin assessment at study visits. All other AEs were spontaneously reported by subject or observed upon examination.</desc>
      <group_list>
        <group group_id="E1">
          <title>M207 Microneedle System 3.8 mg</title>
          <description>M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)&#xD;
M207 Microneedle System: M207 Microneedle System 3.8 mg</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="335"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Foetal disorder</sub_title>
                <description>Fetal chromosomal disorder</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast cancer stage II</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>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="323" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="335"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="316" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Application site swelling</sub_title>
                <counts group_id="E1" subjects_affected="296" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Application site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="225" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Application site bruise</sub_title>
                <counts group_id="E1" subjects_affected="194" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="81" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Application site discolouration</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="335"/>
              </event>
              <event>
                <sub_title>Application site oedema</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="335"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Donald Kellerman, PharmD, Sr. VP, Clin Dev and Med Affairs</name_or_title>
      <organization>Zosano Pharma Corporation</organization>
      <phone>(510) 745-4004</phone>
      <email>dkellerman@zosanopharma.com</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/NCT03282227
org study id: CP-2017-001
nct id: NCT03282227
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, twelve-month safety study. There is a screening period followed by a
      run-in period to record migraine activity. Qualified subjects will receive study medication
      for up to twelve months for the treatment of multiple migraine attacks. Using the electronic
      diary (eDiary) to confirm they are experiencing a qualified migraine, subjects will
      self-administer the patches and respond to questions in the eDiary post treatment
      administration.
This is an open-label, twelve-month safety study. There is a screening period followed by a
      run-in period (14 to 21 days) to determine eligibility for treatment with study medication
      based on daily eDiary data collection. Qualified subjects will receive study medication on
      Day 1 for up to twelve months for the treatment of migraine headaches. Migraines will be
      treated with a single dose, consisting of two patches, but subjects can treat multiple
      migraine attacks throughout the 12 months. Using the eDiary to confirm they are experiencing
      a qualified migraine, subjects will self-administer the patches and continue to respond to
      questions in the eDiary for 48 hours post treatment administration.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single dose, open-label treatment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open-label
measure: Number of Subjects With Any Treatment-emergent Adverse Events (TEAE) Over 12 Months
time frame: 0 to 12 months
description: Number and % of subjects in safety population with any treatment-emergent adverse event(s) during the study. TEAE is defined as any new adverse event (AE) that started after first patch application. This was an open-label study with no control group. No statistical analyses were performed. Application site skin reactions including erythema, swelling, haemorrhage, bruise, pain, and pruritus were collected systematically via subject e-diary and/or investigator skin assessment at study visits. All other AEs were spontaneously reported by subject or observed upon examination.
measure: Percentage of Migraine Attacks for Which Pain Freedom Was Achieved at 2 Hours Post-dose
time frame: 2 hours for each Migraine, up to 12 months for each subject
description: Percentage of migraine attacks for which pain freedom defined as a pain level of 'None' (Grade 0 on pain severity scale where 0: None, 1: Mild, 2: Moderate, 3: Severe, and lower values represent a better outcome) was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.
measure: Percentage of Migraine Attacks for Which Most Bothersome Symptom Freedom Was Achieved at 2 Hours Post-dose
time frame: 2 hours for each Migraine, up to 12 months for each subject
description: Percentage of migraine attacks for which freedom from most bothersome symptom other than pain defined as an absence of the most bothersome symptom was achieved at 2 hours post-dose without the use of rescue medication. This was an open-label study with no control group. No statistical analyses were performed.
measure: Percentage of Migraine Attacks for Which Pain Relief Was Achieved at 2 Hours Post-dose
time frame: 2 hours for each Migraine, up to 12 months for each subject
description: Percentage of migraine attacks for which pain relief defined as an improvement of pain severity (1) to mild (Grade 1) or none (Grade 0) from moderate (Grade 2) or severe (Grade 3) at baseline, or (2) an improvement of pain severity to none (Grade 0) from mild (Grade 1) at baseline, without rescue medication was achieved. Pain severity scale has grades: 0: None, 1: Mild, 2: Moderate, 3: Severe, where lower values represent a better outcome. This was an open-label study with no control group. No statistical analyses were performed.
measure: Percentage of Migraine Attacks for Which Nausea Freedom Was Achieved at 2 Hours Post-dose
time frame: 2 hours for each Migraine, up to 12 months for each subject
description: Percentage of subjects for which nausea freedom defined as absence of nausea and/or vomiting without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.
measure: Percentage of Migraine Attacks for Which Photophobia Freedom Was Achieved at 2 Hours Post-dose
time frame: 2 hours for each Migraine, up to 12 months for each subject
description: Percentage of migraine attacks for which photophobia freedom defined as an absence of photophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.
measure: Percentage of Migraine Attacks for Which Phonophobia Freedom Was Achieved at 2 Hours Post-dose
time frame: 2 hours for each Migraine, up to 12 months for each subject
description: Percentage of migraine attacks for which phonophobia freedom defined as an absence of phonophobia without the use of rescue medication was achieved at 2 hours post-dose. This was an open-label study with no control group. No statistical analyses were performed.
arm group label: M207 Microneedle System 3.8 mg
arm group type: Experimental
description: M207 Microneedle System 3.8 mg (1.9 mg/patch x 2 patches)
intervention type: Drug
intervention name: M207 Microneedle System
description: M207 Microneedle System 3.8 mg
arm group label: M207 Microneedle System 3.8 mg
other name: ZP-Zolmitriptan Intracutaneous Microneedle System
other name: ADAM-Zolmitriptan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Don Kellerman, Pharm.D.
role: Study Director
affiliation: Zosano Pharma Corporation
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country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Oxazolidinones
mesh term: Zolmitriptan
sharing ipd: No
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