<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/NCT03006276</url>
  </required_header>
  <id_info>
    <org_study_id>DFN-15-CD-007</org_study_id>
    <nct_id>NCT03006276</nct_id>
  </id_info>
  <brief_title>Efficacy, Tolerability, and Safety Study of DFN-15</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, and Safety Study of DFN-15 in Episodic Migraine With or Without Aura</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioDelivery Sciences International</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioDelivery Sciences International</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being&#xD;
      conducted at multiple centers in the United States.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1)</measure>
    <time_frame>2 hours post dose</time_frame>
    <description>Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0]) during DB1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)</measure>
    <time_frame>2 hours post dose</time_frame>
    <description>Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)</measure>
    <time_frame>15 minutes through 24 hours</time_frame>
    <description>The percentage of subjects who were free from nausea, photophobia, and phonophobia at 15, 30, and 45 minutes and 1, 1.5, 2, 4, and 24 hours postdose during each DB treatment period were summarized by symptom, treatment group, and time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Headache Pain Relief Postdose (DB1 and DB2)</measure>
    <time_frame>2 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Headache Pain Freedom Postdose (DB1 and DB2)</measure>
    <time_frame>2 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Pain Relief Postdose (DB1 and DB2)</measure>
    <time_frame>15 minutes to 24 hours postdose</time_frame>
    <description>Headache pain relief during postdose in DB1 was defined as a reduction from moderate or severe pain at predose reduced to mild or none postdose, and for DB2 as moderate or severe pain at predose reduced to mild or none postdose, or mild pain at predose reduced to none postdose. Outcome measure shows percentage of subjects experiencing headache pain relief by time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Pain Freedom Postdose (DB1 and DB2)</measure>
    <time_frame>15 minutes to 24 hours postdose</time_frame>
    <description>The percentage of subjects who were pain-free at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2), and 4, and 24 hours postdose during each DB treatment period were summarized by treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absence of Screening MBS at Time Points Postdose (DB1 and DB2)</measure>
    <time_frame>15 minutes to 24 hours postdose</time_frame>
    <description>The percentage of subjects with their Screening MBS (most bothersome symptoms) among nausea, photophobia, and phonophobia (from eDiary data collection) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose during each DB treatment period were summarized by treatment group and time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Disability Score Postdose (DB1 and DB2)</measure>
    <time_frame>2 to 24 hours postdose</time_frame>
    <description>The values of the functional disability scale were: 0=no disability, able to function normally; 1=performance of daily activities mildly impaired, can still do everything but with difficulty; 2=performance of daily activities moderately impaired, unable to do some things; 3=performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary.&#xD;
A decrease in values indicates improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)</measure>
    <time_frame>2 to 4 hours postdose</time_frame>
    <description>The percentage of subjects who were pain-free at 2 and 4 hours postdose during each DB treatment period among those subjects reporting cutaneous allodynia before dosing were summarized by treatment group and time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Pain Freedom Among BMI Category (DB1 and DB2)</measure>
    <time_frame>2 to 4 hours postdose</time_frame>
    <description>The percentage of subjects who were pain-free at 2 and 4 hours postdose whose BMI was &lt;30 kg/m2 vs. subjects whose BMI was ≥30 kg/m2 during each DB treatment period were summarized by treatment group and time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Pain Recurrence Postdose (DB1 and DB2)</measure>
    <time_frame>2 to 24 hours postdose</time_frame>
    <description>Headache pain recurrence was defined as pain-free at 2 hours postdose with pain reported as mild, moderate, or severe at 24 hours postdose. This outcome measure shows percentage of subjects who reported pain-free status and 2 hours postdose but subsequently reported recurrent pain at 24 hours postdose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained Headache Pain Relief Postdose (DB1 and DB2)</measure>
    <time_frame>2 to 24 hours postdose</time_frame>
    <description>Sustained headache pain relief was defined as pain relief at 2 hours postdose with no use of rescue medication and no worsening of headache pain within 2 to 24 hours postdose. This outcome measure shows the percentage of subjects who reported pain relief at 2 hours postdose with no use of rescue medication or worsening of headache pain through 24 hours postdose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained Headache Pain Freedom Postdose (DB1 and DB2)</measure>
    <time_frame>2 to 24 hours postdose</time_frame>
    <description>Sustained headache pain freedom was defined as pain-free at 2 hours postdose, with no use of rescue medication and no recurrence of headache pain within 2 to 24 hours postdose. This outcome measure shows percentage of subjects who were pain-free at 2 hours postdose without the use of rescue medication or recurrence of headache pain through 24 hours postdose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Rescue Medication Postdose (DB1 and DB2)</measure>
    <time_frame>2 to 24 hours postdose</time_frame>
    <description>The percentage of subjects who used rescue mediation after 2 hours (2 to 24 hours) postdose compared between DFN-15 and placebo in each DB period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)</measure>
    <time_frame>2 to 4 hours postdose</time_frame>
    <description>Subject-rated treatment overall satisfaction was based on a 7-point scale at 2 and 4 hours postdose during each DB treatment period. The difference between the subject-rated study drug treatment satisfaction score at 2 and 4 hours postdose and the baseline PPMQ-R (Patient Perception of Migraine Questionnaire) response for the same question were summarized by treatment group (global satisfaction item at baseline asked about the subject's usual migraine treatment). The possible values of the subject treatment satisfaction scale were: 1=very satisfied, 2=satisfied, 3=somewhat satisfied, 4=neither satisfied nor dissatisfied, 5=somewhat dissatisfied, 6=dissatisfied, 7=very dissatisfied.&#xD;
A decrease in values indicates improvement from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)</measure>
    <time_frame>24 hours postdose</time_frame>
    <description>Patient Perception of Migraine Questionnaire-Revised had 30 questions assessing subject's satisfaction with migraine medication, including 3 global items &amp; 4 subscales (i.e., efficacy, function, ease of use, tolerability). A 5-point scale (1-Not At All to 5-Extremely) was used for tolerability subscale questions; a 7-point scale (1-Very Satisfied to 7-Very Dissatisfied) was used for all other subscales and global items. Total score was average of efficacy/function/ease of use subscale scores. Each subscale &amp; total scores were transformed to range from 0-100, with higher scores indicating better satisfaction or tolerability. Total raw score/global items were not transformed. The total raw score could range from 17 (min) to 119 (max), with lower scores indicating better satisfaction. Change from baseline scores at 24-hour-postdose for each subscale score, global item score, total score, &amp; total raw score were summarized by treatment group below.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">622</enrollment>
  <condition>Migraine Headache</condition>
  <arm_group>
    <arm_group_label>DFN-15 Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DFN-15 Active</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DFN-15 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>DFN-15 Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DFN-15 Active</intervention_name>
    <arm_group_label>DFN-15 Active</arm_group_label>
    <other_name>Celecoxib Oral Solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DFN-15 Placebo</intervention_name>
    <arm_group_label>DFN-15 Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A history of episodic migraine, who experience 2 to 8 migraine attacks per month for&#xD;
             at least the past 12 months, with no more than 14 headache days per month, and with 48&#xD;
             hours of headache-free time between migraine attacks.&#xD;
&#xD;
          2. Patients who have migraine with or without aura with onset before age 50 years&#xD;
&#xD;
          3. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity&#xD;
             scale without treatment.&#xD;
&#xD;
          4. Subjects who are willing and able to:&#xD;
&#xD;
               1. Evaluate and record pain, migraine symptoms, and study drug effectiveness&#xD;
                  information in real-time using a subject eDiary for the duration of the study;&#xD;
&#xD;
               2. Record each instance of the use of study drug and rescue medication in real-time&#xD;
                  using a subject eDiary for the duration of the study;&#xD;
&#xD;
               3. Comply with all other study procedures and scheduling requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Minors, even if they are in the specified study age range&#xD;
&#xD;
          2. Medication overuse:&#xD;
&#xD;
               1. Opioids greater than or equal to 10 days during the 90 days prior to screening&#xD;
&#xD;
               2. Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during&#xD;
                  the 90 days prior to screening (applies only if includes opioid and/or&#xD;
                  barbiturate)&#xD;
&#xD;
               3. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14&#xD;
                  days a month during the 90 days prior to screening&#xD;
&#xD;
               4. Triptans or ergots greater than or equal to 10 days a month during the 90 days&#xD;
                  prior to screening&#xD;
&#xD;
          3. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to&#xD;
             screening. (If treated for cosmetic reasons, subjects may be included).&#xD;
&#xD;
          4. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to&#xD;
             randomization.&#xD;
&#xD;
          5. Patients who have received treatment with an investigational drug or device within 30&#xD;
             days of randomization, or participated in a central nervous system clinical trial&#xD;
             within 2 months prior to randomization&#xD;
&#xD;
          6. Patients with positive screening test for human immunodeficiency virus [HIV], positive&#xD;
             hepatitis B surface antigen (HBsAg), or positive hepatitis C virus [HCV] antibody&#xD;
&#xD;
          7. Subjects who are employees or immediate relatives of the employees of the Sponsor, any&#xD;
             of its affiliates or partners, or of the clinical research study site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Site 744</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 727</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 723</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 718</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 709</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 708</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 729</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 725</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 738</name>
      <address>
        <city>Simi Valley</city>
        <state>California</state>
        <zip>93065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 733</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 726</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 735</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 711</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 721</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 740</name>
      <address>
        <city>Blue Ridge</city>
        <state>Georgia</state>
        <zip>30513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 720</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 734</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 739</name>
      <address>
        <city>Prairie Village</city>
        <state>Kansas</state>
        <zip>66208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 713</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 706</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 712</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 703</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 730</name>
      <address>
        <city>New Bedford</city>
        <state>Massachusetts</state>
        <zip>02740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 704</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 736</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <zip>63042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 737</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 745</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 716</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 746</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 705</name>
      <address>
        <city>Manhattan</city>
        <state>New York</state>
        <zip>10018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 743</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 715</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 728</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 707</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 701</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 741</name>
      <address>
        <city>Salem</city>
        <state>Oregon</state>
        <zip>97301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 717</name>
      <address>
        <city>Media</city>
        <state>Pennsylvania</state>
        <zip>19063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 731</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 742</name>
      <address>
        <city>Lincoln</city>
        <state>Rhode Island</state>
        <zip>02865</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 710</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 724</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 719</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 702</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 714</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 722</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/31647577/</url>
    <description>Publication of study results</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <results_first_submitted>April 22, 2022</results_first_submitted>
  <results_first_submitted_qc>December 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 10, 2023</results_first_posted>
  <disposition_first_submitted>December 24, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>December 24, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 27, 2018</disposition_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>May 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03006276/Prot_000.pdf</document_url>
    </provided_document>
    <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 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03006276/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Subjects who received placebo</description>
        </group>
        <group group_id="P2">
          <title>DFN-15</title>
          <description>Subjects who received DFN-15</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-blind Period 1 (DB1)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="311"/>
                <participants group_id="P2" count="311"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Not Completed</title>
              <participants_list>
                <participants group_id="P1" count="43">2 subjects were randomized who were neither recorded as having completed nor discontinued DB1</participants>
                <participants group_id="P2" count="42">4 subjects were randomized who were neither recorded as having completed nor discontinued DB1</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="266"/>
                <participants group_id="P2" count="265"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Double-blind Period 2 (DB2)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
                <participants group_id="P2" count="267"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Not Completed</title>
              <participants_list>
                <participants group_id="P1" count="16">There is a 13 subject discrepancy that is accounted for by erroneous randomization entries and subjects who were randomized but not dosed in DB2.</participants>
                <participants group_id="P2" count="20">There is a 5 subject discrepancy that is accounted for by erroneous randomization entries and subjects who were randomized but not dosed in DB2.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="249"/>
                <participants group_id="P2" count="242"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics list the safety population (i.e., all subjects who were dosed during DB1). Note that there are 2 subjects in the placebo group and 2 subjects in the DFN-15 group, for whom no postdose efficacy data were collected. These individuals are, therefore, included in the baseline subject counts but are not included subsequent results reporting.</population>
      <group_list>
        <group group_id="B1">
          <title>DB1 Placebo</title>
          <description>Subjects received placebo in the Double-blind period 1 (DB1)</description>
        </group>
        <group group_id="B2">
          <title>DB1 DFN-15</title>
          <description>Subjects received DFN-15 in the Double-blind period 1 (DB1)</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="282"/>
            <count group_id="B2" value="285"/>
            <count group_id="B3" value="567"/>
          </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="40.1" spread="12.59"/>
                    <measurement group_id="B2" value="40.5" spread="11.68"/>
                    <measurement group_id="B3" value="40.3" spread="12.12"/>
                  </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="242"/>
                    <measurement group_id="B2" value="252"/>
                    <measurement group_id="B3" value="494"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="73"/>
                  </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="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="243"/>
                    <measurement group_id="B2" value="242"/>
                    <measurement group_id="B3" value="485"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="219"/>
                    <measurement group_id="B2" value="198"/>
                    <measurement group_id="B3" value="417"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1)</title>
        <description>Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0]) during DB1.</description>
        <time_frame>2 hours post dose</time_frame>
        <population>Full Analysis Set 1</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo LOCF</title>
            <description>Placebo - last observation carried forward (LOCF)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 LOCF</title>
            <description>DFN-15 - last observation carried forward (LOCF)</description>
          </group>
          <group group_id="O3">
            <title>Placebo OC</title>
            <description>Placebo - observed cases (OC)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 OC</title>
            <description>DFN-15 - observed cases (OC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1)</title>
          <description>Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0]) during DB1.</description>
          <population>Full Analysis Set 1</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="280"/>
                <count group_id="O4" value="283"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" lower_limit="16.8" upper_limit="27.1"/>
                    <measurement group_id="O2" value="35.6" lower_limit="30.0" upper_limit="41.6"/>
                    <measurement group_id="O3" value="22.1" lower_limit="17.2" upper_limit="27.7"/>
                    <measurement group_id="O4" value="35.8" lower_limit="30.1" upper_limit="41.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Last Observation Carried Forward (LOCF)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.36</ci_lower_limit>
            <ci_upper_limit>2.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.34</ci_lower_limit>
            <ci_upper_limit>2.89</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)</title>
        <description>Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.</description>
        <time_frame>2 hours post dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo LOCF</title>
            <description>Placebo - last observation carried forward (LOCF)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 LOCF</title>
            <description>DFN-15 - last observation carried forward (LOCF)</description>
          </group>
          <group group_id="O3">
            <title>Placebo OC</title>
            <description>Placebo - observed cases (OC)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 OC</title>
            <description>DFN-15 - observed cases (OC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)</title>
          <description>Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="232"/>
                <count group_id="O2" value="232"/>
                <count group_id="O3" value="227"/>
                <count group_id="O4" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.8" lower_limit="38.3" upper_limit="51.5"/>
                    <measurement group_id="O2" value="57.8" lower_limit="51.1" upper_limit="64.2"/>
                    <measurement group_id="O3" value="45.4" lower_limit="38.8" upper_limit="52.1"/>
                    <measurement group_id="O4" value="58.3" lower_limit="51.6" upper_limit="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>last observation carried forward (LOCF)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.17</ci_lower_limit>
            <ci_upper_limit>2.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>observed cases (OC)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.16</ci_lower_limit>
            <ci_upper_limit>2.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)</title>
        <description>The percentage of subjects who were free from nausea, photophobia, and phonophobia at 15, 30, and 45 minutes and 1, 1.5, 2, 4, and 24 hours postdose during each DB treatment period were summarized by symptom, treatment group, and time point.</description>
        <time_frame>15 minutes through 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DB1 Placebo (Nausea)</title>
            <description>Placebo in 1st double-blind treatment phase (DB1) who were nausea free</description>
          </group>
          <group group_id="O2">
            <title>DB1 DFN-15 (Nausea)</title>
            <description>DFN-15 in 1st double-blind treatment phase (DB1) who were nausea free</description>
          </group>
          <group group_id="O3">
            <title>DB1 Placebo (Photophobia)</title>
            <description>Placebo in 1st double-blind treatment phase (DB1) who were photophobia free</description>
          </group>
          <group group_id="O4">
            <title>DB1 DFN-15 (Photophobia)</title>
            <description>DFN-15 in 1st double-blind treatment phase (DB1) who were photophobia free</description>
          </group>
          <group group_id="O5">
            <title>DB1 Placebo (Phonophobia)</title>
            <description>Placebo in 1st double-blind treatment phase (DB1) who were phonophobia free</description>
          </group>
          <group group_id="O6">
            <title>DB1 DFN-15 (Phonophobia)</title>
            <description>DFN-15 in 1st double-blind treatment phase (DB1) who were phonophobia free</description>
          </group>
          <group group_id="O7">
            <title>DB2 Placebo (Nausea)</title>
            <description>Placebo in 2nd double-blind treatment phase (DB2) who were nausea free</description>
          </group>
          <group group_id="O8">
            <title>DB2 DFN-15 (Nausea)</title>
            <description>DFN-15 in 2nd double-blind treatment phase (DB2) who were nausea free</description>
          </group>
          <group group_id="O9">
            <title>DB2 Placebo (Photophobia)</title>
            <description>Placebo in 2nd double-blind treatment phase (DB2) who were photophobia free</description>
          </group>
          <group group_id="O10">
            <title>DB2 DFN-15 (Photophobia)</title>
            <description>DFN-15 in 2nd double-blind treatment phase (DB2) who were photophobia free</description>
          </group>
          <group group_id="O11">
            <title>DB2 Placebo (Phonophobia)</title>
            <description>DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free</description>
          </group>
          <group group_id="O12">
            <title>DB2 DFN-15 (Phonophobia)</title>
            <description>DFN-15 in 2nd double-blind treatment phase (DB2) who were phonophobia free</description>
          </group>
        </group_list>
        <measure>
          <title>Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)</title>
          <description>The percentage of subjects who were free from nausea, photophobia, and phonophobia at 15, 30, and 45 minutes and 1, 1.5, 2, 4, and 24 hours postdose during each DB treatment period were summarized by symptom, treatment group, and time point.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="151"/>
                <count group_id="O2" value="149"/>
                <count group_id="O3" value="243"/>
                <count group_id="O4" value="238"/>
                <count group_id="O5" value="203"/>
                <count group_id="O6" value="195"/>
                <count group_id="O7" value="124"/>
                <count group_id="O8" value="108"/>
                <count group_id="O9" value="208"/>
                <count group_id="O10" value="202"/>
                <count group_id="O11" value="157"/>
                <count group_id="O12" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" lower_limit="10.8" upper_limit="24.3"/>
                    <measurement group_id="O2" value="15.7" lower_limit="10.0" upper_limit="23.0"/>
                    <measurement group_id="O3" value="8.8" lower_limit="5.4" upper_limit="13.5"/>
                    <measurement group_id="O4" value="9.6" lower_limit="5.9" upper_limit="14.4"/>
                    <measurement group_id="O5" value="15.7" lower_limit="10.7" upper_limit="21.9"/>
                    <measurement group_id="O6" value="10.5" lower_limit="6.4" upper_limit="16.1"/>
                    <measurement group_id="O7" value="14.5" lower_limit="8.5" upper_limit="22.5"/>
                    <measurement group_id="O8" value="13.7" lower_limit="7.7" upper_limit="22.0"/>
                    <measurement group_id="O9" value="7.5" lower_limit="4.2" upper_limit="12.2"/>
                    <measurement group_id="O10" value="8.0" lower_limit="4.6" upper_limit="12.9"/>
                    <measurement group_id="O11" value="8.5" lower_limit="4.5" upper_limit="14.4"/>
                    <measurement group_id="O12" value="10.3" lower_limit="6.0" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.6" lower_limit="25.9" upper_limit="41.9"/>
                    <measurement group_id="O2" value="32.9" lower_limit="25.3" upper_limit="41.1"/>
                    <measurement group_id="O3" value="13.0" lower_limit="9.0" upper_limit="18.1"/>
                    <measurement group_id="O4" value="20.1" lower_limit="15.1" upper_limit="25.9"/>
                    <measurement group_id="O5" value="26.0" lower_limit="20.0" upper_limit="32.9"/>
                    <measurement group_id="O6" value="24.6" lower_limit="18.6" upper_limit="31.4"/>
                    <measurement group_id="O7" value="26.9" lower_limit="19.2" upper_limit="35.8"/>
                    <measurement group_id="O8" value="31.4" lower_limit="22.7" upper_limit="41.2"/>
                    <measurement group_id="O9" value="14.4" lower_limit="9.8" upper_limit="20.0"/>
                    <measurement group_id="O10" value="21.9" lower_limit="16.4" upper_limit="28.4"/>
                    <measurement group_id="O11" value="15.6" lower_limit="10.2" upper_limit="22.3"/>
                    <measurement group_id="O12" value="27.4" lower_limit="20.8" upper_limit="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8" lower_limit="35.6" upper_limit="52.3"/>
                    <measurement group_id="O2" value="45.3" lower_limit="37.1" upper_limit="53.7"/>
                    <measurement group_id="O3" value="20.2" lower_limit="15.2" upper_limit="25.9"/>
                    <measurement group_id="O4" value="30.6" lower_limit="24.7" upper_limit="37.0"/>
                    <measurement group_id="O5" value="26.7" lower_limit="20.6" upper_limit="33.5"/>
                    <measurement group_id="O6" value="35.8" lower_limit="29.0" upper_limit="43.0"/>
                    <measurement group_id="O7" value="41.8" lower_limit="32.9" upper_limit="51.1"/>
                    <measurement group_id="O8" value="44.3" lower_limit="34.7" upper_limit="54.3"/>
                    <measurement group_id="O9" value="22.1" lower_limit="16.6" upper_limit="28.4"/>
                    <measurement group_id="O10" value="36.2" lower_limit="29.5" upper_limit="43.3"/>
                    <measurement group_id="O11" value="25.8" lower_limit="19.1" upper_limit="33.4"/>
                    <measurement group_id="O12" value="38.6" lower_limit="31.1" upper_limit="46.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.3" lower_limit="41.0" upper_limit="57.7"/>
                    <measurement group_id="O2" value="56.8" lower_limit="48.4" upper_limit="64.9"/>
                    <measurement group_id="O3" value="26.5" lower_limit="21.0" upper_limit="32.6"/>
                    <measurement group_id="O4" value="38.9" lower_limit="32.6" upper_limit="45.5"/>
                    <measurement group_id="O5" value="38.3" lower_limit="31.4" upper_limit="45.5"/>
                    <measurement group_id="O6" value="45.0" lower_limit="37.8" upper_limit="52.4"/>
                    <measurement group_id="O7" value="52.5" lower_limit="43.2" upper_limit="61.6"/>
                    <measurement group_id="O8" value="51.9" lower_limit="42.0" upper_limit="61.7"/>
                    <measurement group_id="O9" value="27.9" lower_limit="21.9" upper_limit="34.6"/>
                    <measurement group_id="O10" value="43.7" lower_limit="36.7" upper_limit="50.9"/>
                    <measurement group_id="O11" value="34.2" lower_limit="26.8" upper_limit="42.2"/>
                    <measurement group_id="O12" value="44.0" lower_limit="36.3" upper_limit="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.5" lower_limit="50.1" upper_limit="66.6"/>
                    <measurement group_id="O2" value="63.5" lower_limit="55.2" upper_limit="71.3"/>
                    <measurement group_id="O3" value="36.0" lower_limit="29.9" upper_limit="42.5"/>
                    <measurement group_id="O4" value="47.4" lower_limit="40.9" upper_limit="54.0"/>
                    <measurement group_id="O5" value="47.2" lower_limit="40.1" upper_limit="54.4"/>
                    <measurement group_id="O6" value="50.8" lower_limit="43.5" upper_limit="58.1"/>
                    <measurement group_id="O7" value="60.2" lower_limit="50.9" upper_limit="68.9"/>
                    <measurement group_id="O8" value="67.3" lower_limit="57.5" upper_limit="76.0"/>
                    <measurement group_id="O9" value="35.4" lower_limit="28.9" upper_limit="42.4"/>
                    <measurement group_id="O10" value="52.5" lower_limit="45.3" upper_limit="59.6"/>
                    <measurement group_id="O11" value="43.2" lower_limit="35.3" upper_limit="51.4"/>
                    <measurement group_id="O12" value="56.3" lower_limit="48.4" upper_limit="63.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.2" lower_limit="53.8" upper_limit="70.0"/>
                    <measurement group_id="O2" value="67.6" lower_limit="59.4" upper_limit="75.0"/>
                    <measurement group_id="O3" value="44.4" lower_limit="37.9" upper_limit="50.9"/>
                    <measurement group_id="O4" value="58.3" lower_limit="51.7" upper_limit="64.7"/>
                    <measurement group_id="O5" value="54.5" lower_limit="47.3" upper_limit="61.5"/>
                    <measurement group_id="O6" value="61.1" lower_limit="53.9" upper_limit="68.1"/>
                    <measurement group_id="O7" value="66.9" lower_limit="57.9" upper_limit="75.1"/>
                    <measurement group_id="O8" value="69.2" lower_limit="59.5" upper_limit="77.7"/>
                    <measurement group_id="O9" value="45.9" lower_limit="39.0" upper_limit="52.9"/>
                    <measurement group_id="O10" value="64.0" lower_limit="56.9" upper_limit="70.6"/>
                    <measurement group_id="O11" value="48.7" lower_limit="40.6" upper_limit="56.8"/>
                    <measurement group_id="O12" value="67.7" lower_limit="60.0" upper_limit="74.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.5" lower_limit="67.8" upper_limit="82.1"/>
                    <measurement group_id="O2" value="75.0" lower_limit="67.2" upper_limit="81.7"/>
                    <measurement group_id="O3" value="61.2" lower_limit="54.7" upper_limit="67.3"/>
                    <measurement group_id="O4" value="69.9" lower_limit="63.6" upper_limit="75.7"/>
                    <measurement group_id="O5" value="72.9" lower_limit="66.2" upper_limit="78.9"/>
                    <measurement group_id="O6" value="71.5" lower_limit="64.6" upper_limit="77.8"/>
                    <measurement group_id="O7" value="74.2" lower_limit="65.6" upper_limit="81.6"/>
                    <measurement group_id="O8" value="85.0" lower_limit="76.9" upper_limit="91.2"/>
                    <measurement group_id="O9" value="62.8" lower_limit="55.8" upper_limit="69.4"/>
                    <measurement group_id="O10" value="78.1" lower_limit="71.7" upper_limit="83.6"/>
                    <measurement group_id="O11" value="59.0" lower_limit="50.8" upper_limit="66.8"/>
                    <measurement group_id="O12" value="76.2" lower_limit="69.0" upper_limit="82.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.4" lower_limit="85.7" upper_limit="95.3"/>
                    <measurement group_id="O2" value="90.6" lower_limit="84.7" upper_limit="94.8"/>
                    <measurement group_id="O3" value="85.2" lower_limit="80.1" upper_limit="89.4"/>
                    <measurement group_id="O4" value="85.7" lower_limit="80.6" upper_limit="89.9"/>
                    <measurement group_id="O5" value="89.7" lower_limit="84.6" upper_limit="93.5"/>
                    <measurement group_id="O6" value="85.1" lower_limit="79.3" upper_limit="89.8"/>
                    <measurement group_id="O7" value="87.1" lower_limit="79.9" upper_limit="92.4"/>
                    <measurement group_id="O8" value="93.5" lower_limit="87.1" upper_limit="97.4"/>
                    <measurement group_id="O9" value="84.6" lower_limit="79.0" upper_limit="89.2"/>
                    <measurement group_id="O10" value="91.6" lower_limit="86.9" upper_limit="95.0"/>
                    <measurement group_id="O11" value="81.5" lower_limit="74.6" upper_limit="87.3"/>
                    <measurement group_id="O12" value="90.5" lower_limit="85.1" upper_limit="94.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Headache Pain Relief Postdose (DB1 and DB2)</title>
        <time_frame>2 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Headache Pain Relief Postdose (DB1 and DB2)</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.5" spread="29.82"/>
                    <measurement group_id="O2" value="68.9" spread="43.67"/>
                    <measurement group_id="O3" value="55.3" spread="29.22"/>
                    <measurement group_id="O4" value="62.1" spread="29.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Headache Pain Freedom Postdose (DB1 and DB2)</title>
        <time_frame>2 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Headache Pain Freedom Postdose (DB1 and DB2)</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.6" spread="32.31"/>
                    <measurement group_id="O2" value="68.5" spread="31.01"/>
                    <measurement group_id="O3" value="68.8" spread="25.06"/>
                    <measurement group_id="O4" value="80.8" spread="25.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Headache Pain Relief Postdose (DB1 and DB2)</title>
        <description>Headache pain relief during postdose in DB1 was defined as a reduction from moderate or severe pain at predose reduced to mild or none postdose, and for DB2 as moderate or severe pain at predose reduced to mild or none postdose, or mild pain at predose reduced to none postdose. Outcome measure shows percentage of subjects experiencing headache pain relief by time point.</description>
        <time_frame>15 minutes to 24 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Headache Pain Relief Postdose (DB1 and DB2)</title>
          <description>Headache pain relief during postdose in DB1 was defined as a reduction from moderate or severe pain at predose reduced to mild or none postdose, and for DB2 as moderate or severe pain at predose reduced to mild or none postdose, or mild pain at predose reduced to none postdose. Outcome measure shows percentage of subjects experiencing headache pain relief by time point.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6" lower_limit="12.1" upper_limit="22.0"/>
                    <measurement group_id="O2" value="13.4" lower_limit="9.4" upper_limit="18.3"/>
                    <measurement group_id="O3" value="10.9" lower_limit="7.1" upper_limit="15.8"/>
                    <measurement group_id="O4" value="11.7" lower_limit="7.8" upper_limit="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9" lower_limit="23.4" upper_limit="34.9"/>
                    <measurement group_id="O2" value="32.2" lower_limit="26.6" upper_limit="38.2"/>
                    <measurement group_id="O3" value="27.5" lower_limit="21.9" upper_limit="33.7"/>
                    <measurement group_id="O4" value="31.6" lower_limit="25.7" upper_limit="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2" lower_limit="34.2" upper_limit="46.5"/>
                    <measurement group_id="O2" value="46.5" lower_limit="40.4" upper_limit="52.6"/>
                    <measurement group_id="O3" value="37.1" lower_limit="31.0" upper_limit="43.5"/>
                    <measurement group_id="O4" value="47.7" lower_limit="41.2" upper_limit="54.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.1" lower_limit="38.9" upper_limit="51.4"/>
                    <measurement group_id="O2" value="56.8" lower_limit="50.7" upper_limit="62.7"/>
                    <measurement group_id="O3" value="43.8" lower_limit="37.4" upper_limit="50.3"/>
                    <measurement group_id="O4" value="56.1" lower_limit="49.5" upper_limit="62.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.2" lower_limit="48.9" upper_limit="61.4"/>
                    <measurement group_id="O2" value="70.0" lower_limit="64.1" upper_limit="75.3"/>
                    <measurement group_id="O3" value="53.3" lower_limit="46.8" upper_limit="59.7"/>
                    <measurement group_id="O4" value="66.4" lower_limit="60.0" upper_limit="72.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.5" lower_limit="54.3" upper_limit="66.4"/>
                    <measurement group_id="O2" value="74.5" lower_limit="69.0" upper_limit="79.6"/>
                    <measurement group_id="O3" value="60.7" lower_limit="54.2" upper_limit="66.8"/>
                    <measurement group_id="O4" value="74.4" lower_limit="68.3" upper_limit="79.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.2" lower_limit="69.5" upper_limit="80.3"/>
                    <measurement group_id="O2" value="79.6" lower_limit="74.4" upper_limit="84.2"/>
                    <measurement group_id="O3" value="75.0" lower_limit="69.1" upper_limit="80.3"/>
                    <measurement group_id="O4" value="82.2" lower_limit="77.5" upper_limit="87.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.5" lower_limit="88.7" upper_limit="95.4"/>
                    <measurement group_id="O2" value="92.4" lower_limit="88.7" upper_limit="95.3"/>
                    <measurement group_id="O3" value="89.0" lower_limit="84.4" upper_limit="92.6"/>
                    <measurement group_id="O4" value="93.8" lower_limit="89.9" upper_limit="96.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Headache Pain Freedom Postdose (DB1 and DB2)</title>
        <description>The percentage of subjects who were pain-free at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2), and 4, and 24 hours postdose during each DB treatment period were summarized by treatment group.</description>
        <time_frame>15 minutes to 24 hours postdose</time_frame>
        <population>Data were not collected at 2 hours postdose during DB1 per protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Headache Pain Freedom Postdose (DB1 and DB2)</title>
          <description>The percentage of subjects who were pain-free at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2), and 4, and 24 hours postdose during each DB treatment period were summarized by treatment group.</description>
          <population>Data were not collected at 2 hours postdose during DB1 per protocol</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.3" upper_limit="3.7"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.0" upper_limit="2.2"/>
                    <measurement group_id="O3" value="1.4" lower_limit="0.3" upper_limit="3.9"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.1" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="1.6" upper_limit="6.6"/>
                    <measurement group_id="O2" value="3.0" lower_limit="1.3" upper_limit="5.8"/>
                    <measurement group_id="O3" value="6.4" lower_limit="3.6" upper_limit="10.3"/>
                    <measurement group_id="O4" value="6.8" lower_limit="4.0" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" lower_limit="5.5" upper_limit="12.7"/>
                    <measurement group_id="O2" value="11.1" lower_limit="7.6" upper_limit="15.4"/>
                    <measurement group_id="O3" value="11.7" lower_limit="7.9" upper_limit="16.4"/>
                    <measurement group_id="O4" value="12.7" lower_limit="8.7" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" lower_limit="9.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="17.9" lower_limit="13.6" upper_limit="23.0"/>
                    <measurement group_id="O3" value="15.8" lower_limit="11.5" upper_limit="21.1"/>
                    <measurement group_id="O4" value="23.2" lower_limit="18.0" upper_limit="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="13.0" upper_limit="22.5"/>
                    <measurement group_id="O2" value="27.1" lower_limit="21.9" upper_limit="32.8"/>
                    <measurement group_id="O3" value="25.2" lower_limit="19.9" upper_limit="31.2"/>
                    <measurement group_id="O4" value="36.1" lower_limit="30.0" upper_limit="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="31.1" lower_limit="25.4" upper_limit="37.4"/>
                    <measurement group_id="O4" value="46.2" lower_limit="39.8" upper_limit="52.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4" lower_limit="38.3" upper_limit="50.6"/>
                    <measurement group_id="O2" value="56.4" lower_limit="50.3" upper_limit="62.3"/>
                    <measurement group_id="O3" value="50.0" lower_limit="43.6" upper_limit="56.4"/>
                    <measurement group_id="O4" value="61.9" lower_limit="55.4" upper_limit="68.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="248"/>
                    <count group_id="O4" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.2" lower_limit="71.7" upper_limit="82.1"/>
                    <measurement group_id="O2" value="77.3" lower_limit="72.0" upper_limit="82.1"/>
                    <measurement group_id="O3" value="75.1" lower_limit="69.2" upper_limit="80.4"/>
                    <measurement group_id="O4" value="82.9" lower_limit="77.5" upper_limit="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absence of Screening MBS at Time Points Postdose (DB1 and DB2)</title>
        <description>The percentage of subjects with their Screening MBS (most bothersome symptoms) among nausea, photophobia, and phonophobia (from eDiary data collection) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose during each DB treatment period were summarized by treatment group and time point.</description>
        <time_frame>15 minutes to 24 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Absence of Screening MBS at Time Points Postdose (DB1 and DB2)</title>
          <description>The percentage of subjects with their Screening MBS (most bothersome symptoms) among nausea, photophobia, and phonophobia (from eDiary data collection) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose during each DB treatment period were summarized by treatment group and time point.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="6.8" upper_limit="15.6"/>
                    <measurement group_id="O2" value="6.3" lower_limit="3.4" upper_limit="10.5"/>
                    <measurement group_id="O3" value="8.0" lower_limit="4.4" upper_limit="13.1"/>
                    <measurement group_id="O4" value="8.9" lower_limit="5.2" upper_limit="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="12.7" upper_limit="23.0"/>
                    <measurement group_id="O2" value="17.3" lower_limit="12.6" upper_limit="22.9"/>
                    <measurement group_id="O3" value="15.8" lower_limit="10.9" upper_limit="21.8"/>
                    <measurement group_id="O4" value="22.9" lower_limit="17.1" upper_limit="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" lower_limit="17.2" upper_limit="28.5"/>
                    <measurement group_id="O2" value="28.5" lower_limit="22.7" upper_limit="34.8"/>
                    <measurement group_id="O3" value="27.5" lower_limit="21.3" upper_limit="34.3"/>
                    <measurement group_id="O4" value="36.8" lower_limit="30.0" upper_limit="44.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="19.5" upper_limit="31.1"/>
                    <measurement group_id="O2" value="39.6" lower_limit="33.2" upper_limit="46.2"/>
                    <measurement group_id="O3" value="35.8" lower_limit="29.0" upper_limit="43.0"/>
                    <measurement group_id="O4" value="44.7" lower_limit="37.5" upper_limit="52.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" lower_limit="32.4" upper_limit="45.3"/>
                    <measurement group_id="O2" value="49.1" lower_limit="42.5" upper_limit="55.8"/>
                    <measurement group_id="O3" value="42.6" lower_limit="35.5" upper_limit="49.8"/>
                    <measurement group_id="O4" value="53.4" lower_limit="46.1" upper_limit="60.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.8" lower_limit="38.3" upper_limit="51.5"/>
                    <measurement group_id="O2" value="57.8" lower_limit="51.1" upper_limit="64.2"/>
                    <measurement group_id="O3" value="50.0" lower_limit="42.8" upper_limit="57.2"/>
                    <measurement group_id="O4" value="63.4" lower_limit="56.1" upper_limit="70.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.3" lower_limit="54.7" upper_limit="67.5"/>
                    <measurement group_id="O2" value="67.4" lower_limit="61.0" upper_limit="73.4"/>
                    <measurement group_id="O3" value="60.7" lower_limit="53.5" upper_limit="67.6"/>
                    <measurement group_id="O4" value="78.0" lower_limit="71.5" upper_limit="83.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.0" lower_limit="80.9" upper_limit="90.2"/>
                    <measurement group_id="O2" value="82.5" lower_limit="77.0" upper_limit="87.1"/>
                    <measurement group_id="O3" value="83.7" lower_limit="77.7" upper_limit="88.6"/>
                    <measurement group_id="O4" value="89.6" lower_limit="84.4" upper_limit="93.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Functional Disability Score Postdose (DB1 and DB2)</title>
        <description>The values of the functional disability scale were: 0=no disability, able to function normally; 1=performance of daily activities mildly impaired, can still do everything but with difficulty; 2=performance of daily activities moderately impaired, unable to do some things; 3=performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary.&#xD;
A decrease in values indicates improvement from baseline.</description>
        <time_frame>2 to 24 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Functional Disability Score Postdose (DB1 and DB2)</title>
          <description>The values of the functional disability scale were: 0=no disability, able to function normally; 1=performance of daily activities mildly impaired, can still do everything but with difficulty; 2=performance of daily activities moderately impaired, unable to do some things; 3=performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary.&#xD;
A decrease in values indicates improvement from baseline.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="0.94"/>
                    <measurement group_id="O2" value="-0.9" spread="1.00"/>
                    <measurement group_id="O3" value="-0.6" spread="0.83"/>
                    <measurement group_id="O4" value="-0.9" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="0.99"/>
                    <measurement group_id="O2" value="-1.3" spread="1.01"/>
                    <measurement group_id="O3" value="-1.0" spread="0.95"/>
                    <measurement group_id="O4" value="-1.2" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.82"/>
                    <measurement group_id="O2" value="-1.7" spread="0.84"/>
                    <measurement group_id="O3" value="-1.5" spread="0.86"/>
                    <measurement group_id="O4" value="-1.5" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)</title>
        <description>The percentage of subjects who were pain-free at 2 and 4 hours postdose during each DB treatment period among those subjects reporting cutaneous allodynia before dosing were summarized by treatment group and time point.</description>
        <time_frame>2 to 4 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)</title>
          <description>The percentage of subjects who were pain-free at 2 and 4 hours postdose during each DB treatment period among those subjects reporting cutaneous allodynia before dosing were summarized by treatment group and time point.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="9.6" upper_limit="32.5"/>
                    <measurement group_id="O2" value="38.0" lower_limit="24.7" upper_limit="52.8"/>
                    <measurement group_id="O3" value="31.0" lower_limit="17.6" upper_limit="47.1"/>
                    <measurement group_id="O4" value="54.3" lower_limit="39.0" upper_limit="69.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.3" lower_limit="31.6" upper_limit="59.6"/>
                    <measurement group_id="O2" value="56.0" lower_limit="41.3" upper_limit="70.0"/>
                    <measurement group_id="O3" value="40.5" lower_limit="25.6" upper_limit="56.7"/>
                    <measurement group_id="O4" value="56.5" lower_limit="41.1" upper_limit="71.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Headache Pain Freedom Among BMI Category (DB1 and DB2)</title>
        <description>The percentage of subjects who were pain-free at 2 and 4 hours postdose whose BMI was &lt;30 kg/m2 vs. subjects whose BMI was ≥30 kg/m2 during each DB treatment period were summarized by treatment group and time point.</description>
        <time_frame>2 to 4 hours postdose</time_frame>
        <population>Subjects were striated by BMI by dosing assignment for DB1 and DB2, therefore subject numbers differ from overall totals.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Headache Pain Freedom Among BMI Category (DB1 and DB2)</title>
          <description>The percentage of subjects who were pain-free at 2 and 4 hours postdose whose BMI was &lt;30 kg/m2 vs. subjects whose BMI was ≥30 kg/m2 during each DB treatment period were summarized by treatment group and time point.</description>
          <population>Subjects were striated by BMI by dosing assignment for DB1 and DB2, therefore subject numbers differ from overall totals.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 hours postdose (BMI&lt;30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="146"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" lower_limit="15.8" upper_limit="29.7"/>
                    <measurement group_id="O2" value="31.5" lower_limit="24.1" upper_limit="39.7"/>
                    <measurement group_id="O3" value="26.8" lower_limit="19.7" upper_limit="34.8"/>
                    <measurement group_id="O4" value="41.9" lower_limit="32.8" upper_limit="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose (BMI &lt;30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="146"/>
                    <count group_id="O3" value="142"/>
                    <count group_id="O4" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7" lower_limit="33.8" upper_limit="50.0"/>
                    <measurement group_id="O2" value="55.9" lower_limit="47.4" upper_limit="64.1"/>
                    <measurement group_id="O3" value="50.0" lower_limit="41.5" upper_limit="58.5"/>
                    <measurement group_id="O4" value="67.8" lower_limit="58.6" upper_limit="76.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours postdose (BMI&gt;=30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="14.0" upper_limit="29.7"/>
                    <measurement group_id="O2" value="40.3" lower_limit="31.8" upper_limit="49.3"/>
                    <measurement group_id="O3" value="37.3" lower_limit="27.9" upper_limit="47.4"/>
                    <measurement group_id="O4" value="50.4" lower_limit="41.2" upper_limit="59.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose (BMI&gt;=30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                    <count group_id="O2" value="130"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.8" lower_limit="38.4" upper_limit="57.3"/>
                    <measurement group_id="O2" value="56.9" lower_limit="48.0" upper_limit="65.6"/>
                    <measurement group_id="O3" value="50.0" lower_limit="39.9" upper_limit="60.1"/>
                    <measurement group_id="O4" value="56.2" lower_limit="46.9" upper_limit="65.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Headache Pain Recurrence Postdose (DB1 and DB2)</title>
        <description>Headache pain recurrence was defined as pain-free at 2 hours postdose with pain reported as mild, moderate, or severe at 24 hours postdose. This outcome measure shows percentage of subjects who reported pain-free status and 2 hours postdose but subsequently reported recurrent pain at 24 hours postdose.</description>
        <time_frame>2 to 24 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Headache Pain Recurrence Postdose (DB1 and DB2)</title>
          <description>Headache pain recurrence was defined as pain-free at 2 hours postdose with pain reported as mild, moderate, or severe at 24 hours postdose. This outcome measure shows percentage of subjects who reported pain-free status and 2 hours postdose but subsequently reported recurrent pain at 24 hours postdose.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="6.3" upper_limit="25.8"/>
                    <measurement group_id="O2" value="9.2" lower_limit="4.3" upper_limit="16.7"/>
                    <measurement group_id="O3" value="6.6" lower_limit="2.2" upper_limit="14.7"/>
                    <measurement group_id="O4" value="6.4" lower_limit="2.6" upper_limit="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sustained Headache Pain Relief Postdose (DB1 and DB2)</title>
        <description>Sustained headache pain relief was defined as pain relief at 2 hours postdose with no use of rescue medication and no worsening of headache pain within 2 to 24 hours postdose. This outcome measure shows the percentage of subjects who reported pain relief at 2 hours postdose with no use of rescue medication or worsening of headache pain through 24 hours postdose.</description>
        <time_frame>2 to 24 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Headache Pain Relief Postdose (DB1 and DB2)</title>
          <description>Sustained headache pain relief was defined as pain relief at 2 hours postdose with no use of rescue medication and no worsening of headache pain within 2 to 24 hours postdose. This outcome measure shows the percentage of subjects who reported pain relief at 2 hours postdose with no use of rescue medication or worsening of headache pain through 24 hours postdose.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4" lower_limit="36.6" upper_limit="50.4"/>
                    <measurement group_id="O2" value="55.1" lower_limit="48.0" upper_limit="62.1"/>
                    <measurement group_id="O3" value="49.7" lower_limit="42.4" upper_limit="57.1"/>
                    <measurement group_id="O4" value="60.2" lower_limit="52.8" upper_limit="67.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sustained Headache Pain Freedom Postdose (DB1 and DB2)</title>
        <description>Sustained headache pain freedom was defined as pain-free at 2 hours postdose, with no use of rescue medication and no recurrence of headache pain within 2 to 24 hours postdose. This outcome measure shows percentage of subjects who were pain-free at 2 hours postdose without the use of rescue medication or recurrence of headache pain through 24 hours postdose.</description>
        <time_frame>2 to 24 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Headache Pain Freedom Postdose (DB1 and DB2)</title>
          <description>Sustained headache pain freedom was defined as pain-free at 2 hours postdose, with no use of rescue medication and no recurrence of headache pain within 2 to 24 hours postdose. This outcome measure shows percentage of subjects who were pain-free at 2 hours postdose without the use of rescue medication or recurrence of headache pain through 24 hours postdose.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.0" lower_limit="12.2" upper_limit="22.7"/>
                    <measurement group_id="O2" value="26.8" lower_limit="20.9" upper_limit="33.4"/>
                    <measurement group_id="O3" value="26.5" lower_limit="20.3" upper_limit="33.3"/>
                    <measurement group_id="O4" value="39.8" lower_limit="32.7" upper_limit="47.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Rescue Medication Postdose (DB1 and DB2)</title>
        <description>The percentage of subjects who used rescue mediation after 2 hours (2 to 24 hours) postdose compared between DFN-15 and placebo in each DB period.</description>
        <time_frame>2 to 24 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Rescue Medication Postdose (DB1 and DB2)</title>
          <description>The percentage of subjects who used rescue mediation after 2 hours (2 to 24 hours) postdose compared between DFN-15 and placebo in each DB period.</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1" lower_limit="24.7" upper_limit="36.0"/>
                    <measurement group_id="O2" value="15.8" lower_limit="11.7" upper_limit="20.7"/>
                    <measurement group_id="O3" value="18.4" lower_limit="13.7" upper_limit="23.8"/>
                    <measurement group_id="O4" value="16.7" lower_limit="12.2" upper_limit="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)</title>
        <description>Subject-rated treatment overall satisfaction was based on a 7-point scale at 2 and 4 hours postdose during each DB treatment period. The difference between the subject-rated study drug treatment satisfaction score at 2 and 4 hours postdose and the baseline PPMQ-R (Patient Perception of Migraine Questionnaire) response for the same question were summarized by treatment group (global satisfaction item at baseline asked about the subject's usual migraine treatment). The possible values of the subject treatment satisfaction scale were: 1=very satisfied, 2=satisfied, 3=somewhat satisfied, 4=neither satisfied nor dissatisfied, 5=somewhat dissatisfied, 6=dissatisfied, 7=very dissatisfied.&#xD;
A decrease in values indicates improvement from baseline.</description>
        <time_frame>2 to 4 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)</title>
          <description>Subject-rated treatment overall satisfaction was based on a 7-point scale at 2 and 4 hours postdose during each DB treatment period. The difference between the subject-rated study drug treatment satisfaction score at 2 and 4 hours postdose and the baseline PPMQ-R (Patient Perception of Migraine Questionnaire) response for the same question were summarized by treatment group (global satisfaction item at baseline asked about the subject's usual migraine treatment). The possible values of the subject treatment satisfaction scale were: 1=very satisfied, 2=satisfied, 3=somewhat satisfied, 4=neither satisfied nor dissatisfied, 5=somewhat dissatisfied, 6=dissatisfied, 7=very dissatisfied.&#xD;
A decrease in values indicates improvement from baseline.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="287"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="1.90"/>
                    <measurement group_id="O2" value="3.3" spread="1.78"/>
                    <measurement group_id="O3" value="3.6" spread="1.97"/>
                    <measurement group_id="O4" value="3.1" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="2.05"/>
                    <measurement group_id="O2" value="3.2" spread="1.90"/>
                    <measurement group_id="O3" value="3.5" spread="2.06"/>
                    <measurement group_id="O4" value="2.9" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)</title>
        <description>Patient Perception of Migraine Questionnaire-Revised had 30 questions assessing subject's satisfaction with migraine medication, including 3 global items &amp; 4 subscales (i.e., efficacy, function, ease of use, tolerability). A 5-point scale (1-Not At All to 5-Extremely) was used for tolerability subscale questions; a 7-point scale (1-Very Satisfied to 7-Very Dissatisfied) was used for all other subscales and global items. Total score was average of efficacy/function/ease of use subscale scores. Each subscale &amp; total scores were transformed to range from 0-100, with higher scores indicating better satisfaction or tolerability. Total raw score/global items were not transformed. The total raw score could range from 17 (min) to 119 (max), with lower scores indicating better satisfaction. Change from baseline scores at 24-hour-postdose for each subscale score, global item score, total score, &amp; total raw score were summarized by treatment group below.</description>
        <time_frame>24 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects received placebo in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects received DFN-15 in the 1st randomized double blind phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects received placebo in the 2nd randomized double blind phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects received DFN-15 in the 2nd randomized double blind phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)</title>
          <description>Patient Perception of Migraine Questionnaire-Revised had 30 questions assessing subject's satisfaction with migraine medication, including 3 global items &amp; 4 subscales (i.e., efficacy, function, ease of use, tolerability). A 5-point scale (1-Not At All to 5-Extremely) was used for tolerability subscale questions; a 7-point scale (1-Very Satisfied to 7-Very Dissatisfied) was used for all other subscales and global items. Total score was average of efficacy/function/ease of use subscale scores. Each subscale &amp; total scores were transformed to range from 0-100, with higher scores indicating better satisfaction or tolerability. Total raw score/global items were not transformed. The total raw score could range from 17 (min) to 119 (max), with lower scores indicating better satisfaction. Change from baseline scores at 24-hour-postdose for each subscale score, global item score, total score, &amp; total raw score were summarized by treatment group below.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="280"/>
                <count group_id="O2" value="283"/>
                <count group_id="O3" value="248"/>
                <count group_id="O4" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.657" spread="30.9929"/>
                    <measurement group_id="O2" value="4.367" spread="33.7146"/>
                    <measurement group_id="O3" value="3.544" spread="32.3791"/>
                    <measurement group_id="O4" value="3.940" spread="31.7753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Raw Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.835" spread="12.0599"/>
                    <measurement group_id="O2" value="-1.254" spread="12.9334"/>
                    <measurement group_id="O3" value="-0.744" spread="12.3973"/>
                    <measurement group_id="O4" value="-1.448" spread="12.3105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.196" spread="39.0051"/>
                    <measurement group_id="O2" value="2.292" spread="40.8958"/>
                    <measurement group_id="O3" value="0.385" spread="39.7293"/>
                    <measurement group_id="O4" value="3.604" spread="39.9214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.020" spread="40.3093"/>
                    <measurement group_id="O2" value="7.931" spread="42.8913"/>
                    <measurement group_id="O3" value="6.239" spread="39.8213"/>
                    <measurement group_id="O4" value="8.169" spread="38.6639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.247" spread="28.5348"/>
                    <measurement group_id="O2" value="2.876" spread="29.3816"/>
                    <measurement group_id="O3" value="4.009" spread="28.6588"/>
                    <measurement group_id="O4" value="0.047" spread="28.8880"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tolerability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.99" spread="16.521"/>
                    <measurement group_id="O2" value="8.45" spread="15.930"/>
                    <measurement group_id="O3" value="9.01" spread="15.301"/>
                    <measurement group_id="O4" value="6.72" spread="15.565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medication Effectiveness (Global Item)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="2.59"/>
                    <measurement group_id="O2" value="0.2" spread="2.77"/>
                    <measurement group_id="O3" value="0.2" spread="2.64"/>
                    <measurement group_id="O4" value="0.2" spread="2.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Side Effects (Global Item)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.05"/>
                    <measurement group_id="O2" value="2.6" spread="1.36"/>
                    <measurement group_id="O3" value="-0.7" spread="1.88"/>
                    <measurement group_id="O4" value="-0.3" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Satisfaction (Global Item)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="2.67"/>
                    <measurement group_id="O2" value="0.1" spread="2.75"/>
                    <measurement group_id="O3" value="0.1" spread="2.62"/>
                    <measurement group_id="O4" value="0.0" spread="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.</time_frame>
      <desc>For DB1: TEAE that started or worsening of a pre-existing condition on or after the first dose of study drug (DFN-15 or placebo) in to taking DB2 study drug, whichever occurs first.&#xD;
For DB2: TEAE that started or worsened on or after the first dose of study drug in DB2 up to 5 days after the date of the last dose of study drug in DB2.&#xD;
Overall group includes all subjects who received at least one dose of study drug (DFN-15 or placebo) during DB1.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo DB1</title>
          <description>TEAEs that occurred following placebo dose in DB1</description>
        </group>
        <group group_id="E2">
          <title>DFN-15 DB1</title>
          <description>TEAEs that occurred following DFN-15 dose in DB1</description>
        </group>
        <group group_id="E3">
          <title>Placebo DB2</title>
          <description>TEAEs that occurred following placebo dose in DB2</description>
        </group>
        <group group_id="E4">
          <title>DFN-15 DB2</title>
          <description>TEAEs that occurred following DFN-15 dose in DB2</description>
        </group>
        <group group_id="E5">
          <title>Overall</title>
          <description>TEAEs that occurred following the first dose of placebo or DFN-15</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="282"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="567"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="567"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="567"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="249"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="244"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="567"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <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="9" subjects_at_risk="282"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="249"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="244"/>
                <counts group_id="E5" subjects_affected="37" subjects_at_risk="567"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="282"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="249"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="244"/>
                <counts group_id="E5" subjects_affected="19" subjects_at_risk="567"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="282"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="285"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="249"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="244"/>
                <counts group_id="E5" subjects_affected="22" subjects_at_risk="567"/>
              </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>Todd Kunkel, PharmD Director, Scientific Communications</name_or_title>
      <organization>BioDelivery Sciences</organization>
      <phone>913-940-1789</phone>
      <email>tkunkel@bdsi.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/NCT03006276
org study id: DFN-15-CD-007
nct id: NCT03006276
lead sponsor: 
has dmc: No
Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being
      conducted at multiple centers in the United States.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (DB1)
time frame: 2 hours post dose
description: Percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo in the DB1 period (defined as a reduction from predose moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0]) during DB1.
measure: Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose (DB1)
time frame: 2 hours post dose
description: Percentage of subjects who are free from their most bothersome symptom (MBS) among nausea, photophobia, and phonophobia at 2 hours postdose during DB1.
measure: Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
time frame: 15 minutes through 24 hours
description: The percentage of subjects who were free from nausea, photophobia, and phonophobia at 15, 30, and 45 minutes and 1, 1.5, 2, 4, and 24 hours postdose during each DB treatment period were summarized by symptom, treatment group, and time point.
measure: Time to Headache Pain Relief Postdose (DB1 and DB2)
time frame: 2 hours postdose
measure: Time to Headache Pain Freedom Postdose (DB1 and DB2)
time frame: 2 hours postdose
measure: Headache Pain Relief Postdose (DB1 and DB2)
time frame: 15 minutes to 24 hours postdose
description: Headache pain relief during postdose in DB1 was defined as a reduction from moderate or severe pain at predose reduced to mild or none postdose, and for DB2 as moderate or severe pain at predose reduced to mild or none postdose, or mild pain at predose reduced to none postdose. Outcome measure shows percentage of subjects experiencing headache pain relief by time point.
measure: Headache Pain Freedom Postdose (DB1 and DB2)
time frame: 15 minutes to 24 hours postdose
description: The percentage of subjects who were pain-free at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2), and 4, and 24 hours postdose during each DB treatment period were summarized by treatment group.
measure: Absence of Screening MBS at Time Points Postdose (DB1 and DB2)
time frame: 15 minutes to 24 hours postdose
description: The percentage of subjects with their Screening MBS (most bothersome symptoms) among nausea, photophobia, and phonophobia (from eDiary data collection) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose during each DB treatment period were summarized by treatment group and time point.
measure: Change in Functional Disability Score Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: The values of the functional disability scale were: 0=no disability, able to function normally; 1=performance of daily activities mildly impaired, can still do everything but with difficulty; 2=performance of daily activities moderately impaired, unable to do some things; 3=performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary.
A decrease in values indicates improvement from baseline.
measure: Headache Pain Freedom Among Subjects With Cutaneous Allodynia (DB1 and DB2)
time frame: 2 to 4 hours postdose
description: The percentage of subjects who were pain-free at 2 and 4 hours postdose during each DB treatment period among those subjects reporting cutaneous allodynia before dosing were summarized by treatment group and time point.
measure: Headache Pain Freedom Among BMI Category (DB1 and DB2)
time frame: 2 to 4 hours postdose
description: The percentage of subjects who were pain-free at 2 and 4 hours postdose whose BMI was <30 kg/m2 vs. subjects whose BMI was ≥30 kg/m2 during each DB treatment period were summarized by treatment group and time point.
measure: Headache Pain Recurrence Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: Headache pain recurrence was defined as pain-free at 2 hours postdose with pain reported as mild, moderate, or severe at 24 hours postdose. This outcome measure shows percentage of subjects who reported pain-free status and 2 hours postdose but subsequently reported recurrent pain at 24 hours postdose.
measure: Sustained Headache Pain Relief Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: Sustained headache pain relief was defined as pain relief at 2 hours postdose with no use of rescue medication and no worsening of headache pain within 2 to 24 hours postdose. This outcome measure shows the percentage of subjects who reported pain relief at 2 hours postdose with no use of rescue medication or worsening of headache pain through 24 hours postdose.
measure: Sustained Headache Pain Freedom Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: Sustained headache pain freedom was defined as pain-free at 2 hours postdose, with no use of rescue medication and no recurrence of headache pain within 2 to 24 hours postdose. This outcome measure shows percentage of subjects who were pain-free at 2 hours postdose without the use of rescue medication or recurrence of headache pain through 24 hours postdose.
measure: Use of Rescue Medication Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: The percentage of subjects who used rescue mediation after 2 hours (2 to 24 hours) postdose compared between DFN-15 and placebo in each DB period.
measure: Subject-Rated Treatment Satisfaction Postdose (DB1 and DB2)
time frame: 2 to 4 hours postdose
description: Subject-rated treatment overall satisfaction was based on a 7-point scale at 2 and 4 hours postdose during each DB treatment period. The difference between the subject-rated study drug treatment satisfaction score at 2 and 4 hours postdose and the baseline PPMQ-R (Patient Perception of Migraine Questionnaire) response for the same question were summarized by treatment group (global satisfaction item at baseline asked about the subject's usual migraine treatment). The possible values of the subject treatment satisfaction scale were: 1=very satisfied, 2=satisfied, 3=somewhat satisfied, 4=neither satisfied nor dissatisfied, 5=somewhat dissatisfied, 6=dissatisfied, 7=very dissatisfied.
A decrease in values indicates improvement from baseline.
measure: Subject-Rated Treatment Satisfaction at 24 Hours Postdose - PPMQ-R (DB1 and DB2)
time frame: 24 hours postdose
description: Patient Perception of Migraine Questionnaire-Revised had 30 questions assessing subject's satisfaction with migraine medication, including 3 global items & 4 subscales (i.e., efficacy, function, ease of use, tolerability). A 5-point scale (1-Not At All to 5-Extremely) was used for tolerability subscale questions; a 7-point scale (1-Very Satisfied to 7-Very Dissatisfied) was used for all other subscales and global items. Total score was average of efficacy/function/ease of use subscale scores. Each subscale & total scores were transformed to range from 0-100, with higher scores indicating better satisfaction or tolerability. Total raw score/global items were not transformed. The total raw score could range from 17 (min) to 119 (max), with lower scores indicating better satisfaction. Change from baseline scores at 24-hour-postdose for each subscale score, global item score, total score, & total raw score were summarized by treatment group below.
arm group label: DFN-15 Active
arm group type: Experimental
description: DFN-15 Active
arm group label: DFN-15 Placebo
arm group type: Placebo Comparator
description: DFN-15 Placebo
intervention type: Drug
intervention name: DFN-15 Active
arm group label: DFN-15 Active
other name: Celecoxib Oral Solution
intervention type: Other
intervention name: DFN-15 Placebo
arm group label: DFN-15 Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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country: United States
url: https://pubmed.ncbi.nlm.nih.gov/31647577/
description: Publication of study results
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
mesh term: Celecoxib
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 