<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/NCT03009019</url>
  </required_header>
  <id_info>
    <org_study_id>DFN-15-CD-006</org_study_id>
    <nct_id>NCT03009019</nct_id>
  </id_info>
  <brief_title>Efficacy, Tolerability, and Safety 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>
    <collaborator>
      <agency>Dr. Reddy's Laboratories Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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 (First Treated Double-blind Treatment Period)</measure>
    <time_frame>2 hours postdose</time_frame>
    <description>The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose</measure>
    <time_frame>2 hours postdose</time_frame>
    <description>Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo</measure>
    <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>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)</measure>
    <time_frame>15 minutes to 24 hours postdose</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 compared between DFN-15 and placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Headache Pain Relief Postdose (DB1 and DB2)</measure>
    <time_frame>2 hours postdose</time_frame>
    <description>The time to headache pain relief was defined as the time in minutes from when a subject took study drug until the time pain relief was indicated by the subject in the eDiary within 2 hours postdose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Headache Pain Freedom Postdose (DB1 and DB2)</measure>
    <time_frame>2 hours postdose</time_frame>
    <description>The time to headache pain freedom was defined as the time in minutes from when a subject took study drug until the time pain freedom was indicated by the subject in the eDiary within 2 hours postdose.</description>
  </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 was defined for DB1 as a reduction from moderate or severe pain before dosing to mild or none postdose, and for DB2 as moderate or severe pain before dosing reduced to mild or none postdose, or mild pain before dosing reduced to none postdose. Data are reported by percentage reporting headache pain relief over time postdose.</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 period), 4, and 24 hours postdose compared between DFN-15 and placebo</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 Symptom) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose compared between DFN-15 and placebo.</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>Change in functional disability score at 2, 4, and 24 hours postdose compared between DFN-15 and placebo. 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 and 4 hours postdose</time_frame>
    <description>The percentage of subjects who were pain-free at 2 and 4 hours postdose compared between DFN-15 and placebo, among those reporting cutaneous allodynia predose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Pain Freedom Among BMI Category (DB1 and DB2)</measure>
    <time_frame>2 and 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, and whose BMI was &lt; 25 kg/m2 vs. subjects whose BMI was ≥ 25 kg/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Pain Recurrence Postdose (DB1 and DB2)</measure>
    <time_frame>2 to 24 hours postdose</time_frame>
    <description>The percentage of subjects who had pain recurrence between 2 to 24 hours (i.e., pain-free at 2 hours postdose, with pain [mild, moderate, or severe] reported at 24 hours postdose) compared between DFN-15 and placebo</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>The percentage of the population of subjects who reported headache pain relief between 2 and 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>The percentage of subjects who had sustained pain freedom at 2 to 24 hours postdose compared between DFN-15 and placebo in each DB period. Sustained pain freedom at 2 to 24 hours postdose is 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</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 medication 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 and 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">631</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 609</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 640</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 622</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 616</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 637</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 615</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 646</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 619</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 624</name>
      <address>
        <city>San Marcos</city>
        <state>California</state>
        <zip>92078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 631</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 603</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 641</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>32763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 629</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 601</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 625</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 630</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 642</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 604</name>
      <address>
        <city>Blue Island</city>
        <state>Illinois</state>
        <zip>60406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 602</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 644</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 610</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 634</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 623</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 638</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 606</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 613</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 647</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 618</name>
      <address>
        <city>Nashua</city>
        <state>New Hampshire</state>
        <zip>03060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 636</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 645</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 608</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 620</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 643</name>
      <address>
        <city>Mooresville</city>
        <state>North Carolina</state>
        <zip>28117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 626</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 628</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 614</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 639</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 612</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 627</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 611</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 632</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 621</name>
      <address>
        <city>Taylorsville</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 635</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/34447267/</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 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</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/19/NCT03009019/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/19/NCT03009019/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DFN-15</title>
          <description>Subjects who received DFN-15 (active study drug)</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Subjects who received placebo equivalent for 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="316">4 subjects included in the 'Started' &amp; 'Not Completed' tallies were randomized but not dosed</participants>
                <participants group_id="P2" count="315">2 subjects included in the 'Started' &amp; 'Not Completed' tallies were randomized but not dosed</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="280"/>
                <participants group_id="P2" count="264"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="51"/>
              </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="272">4 subjects included in the 'Started' &amp; 'Not Completed' tallies were randomized but not dosed</participants>
                <participants group_id="P2" count="273">1 subject included in the 'Started' &amp; 'Not Completed' tallies was randomized but not dosed</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="251"/>
                <participants group_id="P2" count="253"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Set 1 (for DB1)</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="283"/>
            <count group_id="B2" value="289"/>
            <count group_id="B3" value="572"/>
          </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="40.4" spread="12.99"/>
                    <measurement group_id="B2" value="41.4" spread="13.94"/>
                    <measurement group_id="B3" value="41.0" spread="13.44"/>
                  </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="245"/>
                    <measurement group_id="B2" value="237"/>
                    <measurement group_id="B3" value="482"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="90"/>
                  </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="41"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="241"/>
                    <measurement group_id="B2" value="248"/>
                    <measurement group_id="B3" value="489"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="209"/>
                    <measurement group_id="B2" value="214"/>
                    <measurement group_id="B3" value="423"/>
                  </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="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </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 (First Treated Double-blind Treatment Period)</title>
        <description>The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0]</description>
        <time_frame>2 hours postdose</time_frame>
        <population>Full Analysis Set 1</population>
        <group_list>
          <group group_id="O1">
            <title>DFN-15 Placebo (LOCF)</title>
            <description>last observation carried forward (LOCF)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 Active (LOCF)</title>
            <description>last observation carried forward (LOCF)</description>
          </group>
          <group group_id="O3">
            <title>DFN-15 Placebo (OC)</title>
            <description>observed cases (OC)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 Active (OC)</title>
            <description>observed cases (OC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Are Pain-free at 2 Hours Postdose (First Treated Double-blind Treatment Period)</title>
          <description>The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0]</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="267"/>
                <count group_id="O2" value="280"/>
                <count group_id="O3" value="256"/>
                <count group_id="O4" value="275"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8" lower_limit="20.7" upper_limit="31.5"/>
                    <measurement group_id="O2" value="32.9" lower_limit="27.4" upper_limit="38.7"/>
                    <measurement group_id="O3" value="24.6" lower_limit="19.5" upper_limit="30.4"/>
                    <measurement group_id="O4" value="32.4" lower_limit="26.9" upper_limit="38.2"/>
                  </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>0.075</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>2.03</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>0.055</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>2.14</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</title>
        <description>Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)</description>
        <time_frame>2 hours postdose</time_frame>
        <population>Full Analysis Set 1</population>
        <group_list>
          <group group_id="O1">
            <title>DFN-15 Placebo (LOCF)</title>
            <description>last observation carried forward (LOCF)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 Active (LOCF)</title>
            <description>last observation carried forward (LOCF)</description>
          </group>
          <group group_id="O3">
            <title>DFN-15 Placebo (OC)</title>
            <description>Observed cases (OC)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 Active (OC)</title>
            <description>Observed cases (OC)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose</title>
          <description>Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)</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="272"/>
                <count group_id="O2" value="278"/>
                <count group_id="O3" value="272"/>
                <count group_id="O4" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.0" lower_limit="38.5" upper_limit="51.7"/>
                    <measurement group_id="O2" value="58.9" lower_limit="52.4" upper_limit="65.2"/>
                    <measurement group_id="O3" value="44.4" lower_limit="37.8" upper_limit="51.2"/>
                    <measurement group_id="O4" value="58.5" lower_limit="51.9" 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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.22</ci_lower_limit>
            <ci_upper_limit>2.52</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>0.003</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.22</ci_lower_limit>
            <ci_upper_limit>2.55</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo</title>
        <description>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.</description>
        <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>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Subjects with treatment-emergent adverse events (TEAEs) following placebo in the 1st double-blind treatment phase (DB1)</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>Subjects with treatment-emergent adverse events (TEAEs) following DFN-15 in the 1st double-blind treatment phase (DB1)</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Subjects with treatment-emergent adverse events (TEAEs) following placebo in the 2nd double-blind treatment phase (DB2)</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>Subjects with treatment-emergent adverse events (TEAEs) following DFN-15 in the 2nd double-blind treatment phase (DB2)</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo</title>
          <description>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.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="283"/>
                <count group_id="O2" value="289"/>
                <count group_id="O3" value="254"/>
                <count group_id="O4" value="251"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </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 compared between DFN-15 and placebo</description>
        <time_frame>15 minutes to 24 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1 Nausea</title>
            <description>Subjects reporting nausea at time 0</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1 Nausea</title>
            <description>Subjects reporting nausea at time 0</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB1 Photophobia</title>
            <description>Subjects reporting photophobia at time 0</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB1 Photophobia</title>
            <description>Subjects reporting photophobia at time 0</description>
          </group>
          <group group_id="O5">
            <title>Placebo DB1 Phonophobia</title>
            <description>Subjects reporting phonophobia at time 0</description>
          </group>
          <group group_id="O6">
            <title>DFN-15 DB1 Phonophobia</title>
            <description>Subjects reporting phonophobia at time 0</description>
          </group>
          <group group_id="O7">
            <title>Placebo DB2 Nausea</title>
            <description>Subjects reporting nausea at time 0</description>
          </group>
          <group group_id="O8">
            <title>DFN-15 DB2 Nausea</title>
            <description>Subjects reporting nausea at time 0</description>
          </group>
          <group group_id="O9">
            <title>Placebo DB2 Photophobia</title>
            <description>Subjects reporting photophobia at time 0</description>
          </group>
          <group group_id="O10">
            <title>DFN-15 DB2 Photophobia</title>
            <description>Subjects reporting photophobia at time 0</description>
          </group>
          <group group_id="O11">
            <title>Placebo DB2 Phonophobia</title>
            <description>Subjects reporting phonophobia at time 0</description>
          </group>
          <group group_id="O12">
            <title>DFN-15 DB2 Phonophobia</title>
            <description>Subjects reporting phonophobia at time 0</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 compared between DFN-15 and placebo</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="147"/>
                <count group_id="O2" value="154"/>
                <count group_id="O3" value="242"/>
                <count group_id="O4" value="245"/>
                <count group_id="O5" value="206"/>
                <count group_id="O6" value="198"/>
                <count group_id="O7" value="109"/>
                <count group_id="O8" value="120"/>
                <count group_id="O9" value="203"/>
                <count group_id="O10" value="208"/>
                <count group_id="O11" value="170"/>
                <count group_id="O12" value="167"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3" lower_limit="13.7" upper_limit="28.3"/>
                    <measurement group_id="O2" value="14.3" lower_limit="8.8" upper_limit="21.4"/>
                    <measurement group_id="O3" value="6.2" lower_limit="3.3" upper_limit="10.3"/>
                    <measurement group_id="O4" value="9.0" lower_limit="5.5" upper_limit="13.6"/>
                    <measurement group_id="O5" value="11.1" lower_limit="6.9" upper_limit="16.6"/>
                    <measurement group_id="O6" value="15.5" lower_limit="10.5" upper_limit="21.8"/>
                    <measurement group_id="O7" value="10.4" lower_limit="5.1" upper_limit="18.3"/>
                    <measurement group_id="O8" value="16.2" lower_limit="9.7" upper_limit="24.7"/>
                    <measurement group_id="O9" value="3.3" lower_limit="1.2" upper_limit="7.1"/>
                    <measurement group_id="O10" value="10.4" lower_limit="6.4" upper_limit="15.8"/>
                    <measurement group_id="O11" value="8.7" lower_limit="4.7" upper_limit="14.4"/>
                    <measurement group_id="O12" value="13.2" lower_limit="8.1" upper_limit="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3" lower_limit="27.3" upper_limit="43.9"/>
                    <measurement group_id="O2" value="32.4" lower_limit="25.0" upper_limit="40.6"/>
                    <measurement group_id="O3" value="14.7" lower_limit="10.3" upper_limit="20.0"/>
                    <measurement group_id="O4" value="15.9" lower_limit="11.4" upper_limit="21.2"/>
                    <measurement group_id="O5" value="16.8" lower_limit="11.8" upper_limit="22.8"/>
                    <measurement group_id="O6" value="24.5" lower_limit="18.5" upper_limit="31.3"/>
                    <measurement group_id="O7" value="27.5" lower_limit="19.1" upper_limit="37.2"/>
                    <measurement group_id="O8" value="27.2" lower_limit="19.3" upper_limit="36.3"/>
                    <measurement group_id="O9" value="15.0" lower_limit="10.3" upper_limit="20.9"/>
                    <measurement group_id="O10" value="21.2" lower_limit="15.7" upper_limit="27.6"/>
                    <measurement group_id="O11" value="19.5" lower_limit="13.6" upper_limit="26.5"/>
                    <measurement group_id="O12" value="25.9" lower_limit="19.3" upper_limit="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" lower_limit="32.1" upper_limit="48.9"/>
                    <measurement group_id="O2" value="44.4" lower_limit="36.3" upper_limit="52.7"/>
                    <measurement group_id="O3" value="22.8" lower_limit="17.5" upper_limit="28.8"/>
                    <measurement group_id="O4" value="25.2" lower_limit="19.8" upper_limit="31.2"/>
                    <measurement group_id="O5" value="29.4" lower_limit="23.1" upper_limit="36.3"/>
                    <measurement group_id="O6" value="33.9" lower_limit="27.2" upper_limit="41.0"/>
                    <measurement group_id="O7" value="40.4" lower_limit="31.2" upper_limit="50.9"/>
                    <measurement group_id="O8" value="44.0" lower_limit="34.8" upper_limit="53.5"/>
                    <measurement group_id="O9" value="25.3" lower_limit="19.3" upper_limit="32.0"/>
                    <measurement group_id="O10" value="30.2" lower_limit="23.9" upper_limit="37.0"/>
                    <measurement group_id="O11" value="29.2" lower_limit="22.3" upper_limit="36.9"/>
                    <measurement group_id="O12" value="36.9" lower_limit="29.4" upper_limit="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.8" lower_limit="37.4" upper_limit="54.3"/>
                    <measurement group_id="O2" value="55.9" lower_limit="47.6" upper_limit="64.0"/>
                    <measurement group_id="O3" value="25.9" lower_limit="20.4" upper_limit="32.0"/>
                    <measurement group_id="O4" value="32.0" lower_limit="26.1" upper_limit="38.2"/>
                    <measurement group_id="O5" value="32.5" lower_limit="26.0" upper_limit="39.5"/>
                    <measurement group_id="O6" value="39.5" lower_limit="32.6" upper_limit="46.7"/>
                    <measurement group_id="O7" value="55.1" lower_limit="45.2" upper_limit="65.8"/>
                    <measurement group_id="O8" value="56.9" lower_limit="47.4" upper_limit="66.1"/>
                    <measurement group_id="O9" value="30.8" lower_limit="24.5" upper_limit="37.7"/>
                    <measurement group_id="O10" value="37.2" lower_limit="30.5" upper_limit="44.3"/>
                    <measurement group_id="O11" value="38.2" lower_limit="30.7" upper_limit="46.1"/>
                    <measurement group_id="O12" value="48.1" lower_limit="40.2" upper_limit="56.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.5" lower_limit="45.0" upper_limit="61.9"/>
                    <measurement group_id="O2" value="58.8" lower_limit="50.6" upper_limit="66.7"/>
                    <measurement group_id="O3" value="35.6" lower_limit="29.5" upper_limit="42.1"/>
                    <measurement group_id="O4" value="46.3" lower_limit="39.9" upper_limit="52.8"/>
                    <measurement group_id="O5" value="40.9" lower_limit="34.0" upper_limit="48.1"/>
                    <measurement group_id="O6" value="52.0" lower_limit="44.8" upper_limit="59.2"/>
                    <measurement group_id="O7" value="58.9" lower_limit="49.0" upper_limit="68.3"/>
                    <measurement group_id="O8" value="62.9" lower_limit="53.5" upper_limit="71.7"/>
                    <measurement group_id="O9" value="42.2" lower_limit="35.3" upper_limit="49.4"/>
                    <measurement group_id="O10" value="48.2" lower_limit="41.1" upper_limit="55.4"/>
                    <measurement group_id="O11" value="52.4" lower_limit="44.5" upper_limit="60.2"/>
                    <measurement group_id="O12" value="55.6" lower_limit="47.6" upper_limit="63.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.4" lower_limit="51.9" upper_limit="68.5"/>
                    <measurement group_id="O2" value="66.7" lower_limit="58.6" upper_limit="74.1"/>
                    <measurement group_id="O3" value="42.9" lower_limit="36.5" upper_limit="49.4"/>
                    <measurement group_id="O4" value="58.0" lower_limit="51.5" upper_limit="64.3"/>
                    <measurement group_id="O5" value="47.0" lower_limit="40.0" upper_limit="54.2"/>
                    <measurement group_id="O6" value="59.2" lower_limit="52.0" upper_limit="66.1"/>
                    <measurement group_id="O7" value="68.5" lower_limit="58.9" upper_limit="77.1"/>
                    <measurement group_id="O8" value="72.9" lower_limit="63.9" upper_limit="80.7"/>
                    <measurement group_id="O9" value="50.3" lower_limit="43.1" upper_limit="57.4"/>
                    <measurement group_id="O10" value="53.7" lower_limit="46.6" upper_limit="60.7"/>
                    <measurement group_id="O11" value="53.9" lower_limit="46.0" upper_limit="61.6"/>
                    <measurement group_id="O12" value="61.3" lower_limit="53.4" upper_limit="68.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0" lower_limit="66.1" upper_limit="80.9"/>
                    <measurement group_id="O2" value="83.0" lower_limit="76.1" upper_limit="88.6"/>
                    <measurement group_id="O3" value="57.5" lower_limit="51.0" upper_limit="63.8"/>
                    <measurement group_id="O4" value="70.5" lower_limit="64.3" upper_limit="76.1"/>
                    <measurement group_id="O5" value="65.2" lower_limit="58.2" upper_limit="71.7"/>
                    <measurement group_id="O6" value="68.5" lower_limit="61.5" upper_limit="74.9"/>
                    <measurement group_id="O7" value="73.1" lower_limit="63.8" upper_limit="81.2"/>
                    <measurement group_id="O8" value="84.0" lower_limit="76.2" upper_limit="90.1"/>
                    <measurement group_id="O9" value="61.0" lower_limit="53.9" upper_limit="67.8"/>
                    <measurement group_id="O10" value="73.7" lower_limit="67.1" upper_limit="79.5"/>
                    <measurement group_id="O11" value="69.5" lower_limit="61.9" upper_limit="76.3"/>
                    <measurement group_id="O12" value="75.8" lower_limit="65.5" upper_limit="82.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.1" lower_limit="82.9" upper_limit="93.6"/>
                    <measurement group_id="O2" value="89.6" lower_limit="83.7" upper_limit="93.9"/>
                    <measurement group_id="O3" value="83.9" lower_limit="78.6" upper_limit="88.3"/>
                    <measurement group_id="O4" value="86.5" lower_limit="81.6" upper_limit="90.5"/>
                    <measurement group_id="O5" value="82.5" lower_limit="76.6" upper_limit="87.4"/>
                    <measurement group_id="O6" value="88.9" lower_limit="83.7" upper_limit="92.9"/>
                    <measurement group_id="O7" value="90.8" lower_limit="83.8" upper_limit="95.5"/>
                    <measurement group_id="O8" value="93.3" lower_limit="87.3" upper_limit="97.1"/>
                    <measurement group_id="O9" value="85.7" lower_limit="80.1" upper_limit="90.2"/>
                    <measurement group_id="O10" value="90.4" lower_limit="85.5" upper_limit="94.0"/>
                    <measurement group_id="O11" value="87.6" lower_limit="81.7" upper_limit="92.2"/>
                    <measurement group_id="O12" value="89.2" lower_limit="83.5" upper_limit="93.5"/>
                  </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>
        <description>The time to headache pain relief was defined as the time in minutes from when a subject took study drug until the time pain relief was indicated by the subject in the eDiary within 2 hours postdose.</description>
        <time_frame>2 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Placebo received in DB1</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>DFN-15 received in DB1</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Placebo received in DB2</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>DFN-15 received in DB2</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Headache Pain Relief Postdose (DB1 and DB2)</title>
          <description>The time to headache pain relief was defined as the time in minutes from when a subject took study drug until the time pain relief was indicated by the subject in the eDiary within 2 hours postdose.</description>
          <units>time (hours)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Due to the small number of subjects who completed this assessment, the median time to headache pain relief was non-evaluable from the Kaplan-Meier survival estimation.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Due to the small number of subjects who completed this assessment, the median time to headache pain relief was non-evaluable from the Kaplan-Meier survival estimation.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Due to the small number of subjects who completed this assessment, the median time to headache pain relief was non-evaluable from the Kaplan-Meier survival estimation.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Due to the small number of subjects who completed this assessment, the median time to headache pain relief was non-evaluable from the Kaplan-Meier survival estimation.</measurement>
                  </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>
        <description>The time to headache pain freedom was defined as the time in minutes from when a subject took study drug until the time pain freedom was indicated by the subject in the eDiary within 2 hours postdose.</description>
        <time_frame>2 hours postdose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo DB1</title>
            <description>Placebo received during DB1</description>
          </group>
          <group group_id="O2">
            <title>DFN-15 DB1</title>
            <description>DFN-15 received during DB1</description>
          </group>
          <group group_id="O3">
            <title>Placebo DB2</title>
            <description>Placebo received during DB2</description>
          </group>
          <group group_id="O4">
            <title>DFN-15 DB2</title>
            <description>DFN-15 received during DB2</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Headache Pain Freedom Postdose (DB1 and DB2)</title>
          <description>The time to headache pain freedom was defined as the time in minutes from when a subject took study drug until the time pain freedom was indicated by the subject in the eDiary within 2 hours postdose.</description>
          <units>time (minutes)</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Due to the small number of subjects who completed this assessment, time to headache pain freedom was non-evaluable from the Kaplan-Meier survival estimation</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Due to the small number of subjects who completed this assessment, time to headache pain freedom was non-evaluable from the Kaplan-Meier survival estimation</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Due to the small number of subjects who completed this assessment, time to headache pain freedom was non-evaluable from the Kaplan-Meier survival estimation</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Due to the small number of subjects who completed this assessment, time to headache pain freedom was non-evaluable from the Kaplan-Meier survival estimation</measurement>
                  </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 was defined for DB1 as a reduction from moderate or severe pain before dosing to mild or none postdose, and for DB2 as moderate or severe pain before dosing reduced to mild or none postdose, or mild pain before dosing reduced to none postdose. Data are reported by percentage reporting headache pain relief over time postdose.</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 was defined for DB1 as a reduction from moderate or severe pain before dosing to mild or none postdose, and for DB2 as moderate or severe pain before dosing reduced to mild or none postdose, or mild pain before dosing reduced to none postdose. Data are reported by percentage reporting headache pain relief over time 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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" lower_limit="8.6" upper_limit="17.4"/>
                    <measurement group_id="O2" value="12.6" lower_limit="8.7" upper_limit="17.3"/>
                    <measurement group_id="O3" value="7.9" lower_limit="4.7" upper_limit="12.3"/>
                    <measurement group_id="O4" value="15.0" lower_limit="10.5" upper_limit="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.4" lower_limit="17.5" upper_limit="28.1"/>
                    <measurement group_id="O2" value="25.3" lower_limit="20.2" upper_limit="30.9"/>
                    <measurement group_id="O3" value="23.0" lower_limit="17.8" upper_limit="29.0"/>
                    <measurement group_id="O4" value="28.0" lower_limit="22.3" upper_limit="34.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0" lower_limit="29.2" upper_limit="41.2"/>
                    <measurement group_id="O2" value="40.0" lower_limit="34.2" upper_limit="46.1"/>
                    <measurement group_id="O3" value="35.3" lower_limit="29.2" upper_limit="41.9"/>
                    <measurement group_id="O4" value="40.0" lower_limit="33.7" upper_limit="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.8" lower_limit="33.9" upper_limit="46.1"/>
                    <measurement group_id="O2" value="49.6" lower_limit="43.6" upper_limit="55.7"/>
                    <measurement group_id="O3" value="41.9" lower_limit="35.6" upper_limit="48.5"/>
                    <measurement group_id="O4" value="52.8" lower_limit="46.2" upper_limit="59.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.6" lower_limit="43.4" upper_limit="55.8"/>
                    <measurement group_id="O2" value="58.8" lower_limit="52.8" upper_limit="64.6"/>
                    <measurement group_id="O3" value="51.9" lower_limit="45.3" upper_limit="58.4"/>
                    <measurement group_id="O4" value="62.7" lower_limit="56.2" upper_limit="68.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.9" lower_limit="50.8" upper_limit="62.9"/>
                    <measurement group_id="O2" value="68.6" lower_limit="62.8" upper_limit="74.0"/>
                    <measurement group_id="O3" value="58.6" lower_limit="52.0" upper_limit="64.9"/>
                    <measurement group_id="O4" value="69.6" lower_limit="63.3" upper_limit="75.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.8" lower_limit="68.1" upper_limit="78.9"/>
                    <measurement group_id="O2" value="82.9" lower_limit="78.0" upper_limit="87.1"/>
                    <measurement group_id="O3" value="74.6" lower_limit="68.6" upper_limit="80.0"/>
                    <measurement group_id="O4" value="84.7" lower_limit="79.5" upper_limit="89.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.7" lower_limit="89.0" upper_limit="95.5"/>
                    <measurement group_id="O2" value="94.3" lower_limit="90.9" upper_limit="96.7"/>
                    <measurement group_id="O3" value="88.2" lower_limit="83.4" upper_limit="91.9"/>
                    <measurement group_id="O4" value="95.1" lower_limit="91.6" upper_limit="97.4"/>
                  </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 period), 4, and 24 hours postdose compared between DFN-15 and placebo</description>
        <time_frame>15 minutes to 24 hours postdose</time_frame>
        <population>data for 2 hours postdose were not collected for 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 period), 4, and 24 hours postdose compared between DFN-15 and placebo</description>
          <population>data for 2 hours postdose were not collected for 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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </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="287"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="1.2" upper_limit="5.9"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0.3" upper_limit="3.5"/>
                    <measurement group_id="O3" value="0.5" lower_limit="0.0" upper_limit="2.6"/>
                    <measurement group_id="O4" value="2.8" lower_limit="1.0" upper_limit="6.0"/>
                  </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="287"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="3.0" upper_limit="9.1"/>
                    <measurement group_id="O2" value="3.7" lower_limit="1.8" upper_limit="6.7"/>
                    <measurement group_id="O3" value="1.7" lower_limit="0.5" upper_limit="4.4"/>
                    <measurement group_id="O4" value="8.6" lower_limit="5.3" upper_limit="13.0"/>
                  </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="287"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" lower_limit="6.4" upper_limit="14.0"/>
                    <measurement group_id="O2" value="9.5" lower_limit="6.3" upper_limit="13.5"/>
                    <measurement group_id="O3" value="7.3" lower_limit="4.3" upper_limit="11.5"/>
                    <measurement group_id="O4" value="11.9" lower_limit="8.1" upper_limit="16.8"/>
                  </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="287"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" lower_limit="8.9" upper_limit="17.3"/>
                    <measurement group_id="O2" value="18.0" lower_limit="13.7" upper_limit="23.0"/>
                    <measurement group_id="O3" value="11.9" lower_limit="8.0" upper_limit="16.7"/>
                    <measurement group_id="O4" value="18.7" lower_limit="13.9" upper_limit="24.3"/>
                  </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="287"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8" lower_limit="15.2" upper_limit="25.2"/>
                    <measurement group_id="O2" value="24.7" lower_limit="19.8" upper_limit="30.2"/>
                    <measurement group_id="O3" value="20.7" lower_limit="15.7" upper_limit="26.4"/>
                    <measurement group_id="O4" value="27.1" lower_limit="21.6" upper_limit="33.3"/>
                  </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="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="24.3" lower_limit="19.0" upper_limit="30.2"/>
                    <measurement group_id="O4" value="36.7" lower_limit="30.6" upper_limit="43.1"/>
                  </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="287"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2" lower_limit="34.3" upper_limit="46.3"/>
                    <measurement group_id="O2" value="49.1" lower_limit="43.1" upper_limit="55.1"/>
                    <measurement group_id="O3" value="46.7" lower_limit="40.2" upper_limit="53.2"/>
                    <measurement group_id="O4" value="59.1" lower_limit="52.6" upper_limit="65.3"/>
                  </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="287"/>
                    <count group_id="O3" value="253"/>
                    <count group_id="O4" value="250"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.9" lower_limit="66.2" upper_limit="77.1"/>
                    <measurement group_id="O2" value="79.4" lower_limit="74.2" upper_limit="84.0"/>
                    <measurement group_id="O3" value="74.7" lower_limit="68.8" upper_limit="80.0"/>
                    <measurement group_id="O4" value="85.3" lower_limit="80.2" upper_limit="89.5"/>
                  </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 Symptom) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose compared between DFN-15 and placebo.</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 Symptom) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose compared between DFN-15 and placebo.</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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="4.9" upper_limit="12.9"/>
                    <measurement group_id="O2" value="10.4" lower_limit="6.6" upper_limit="15.3"/>
                    <measurement group_id="O3" value="5.8" lower_limit="2.8" upper_limit="10.5"/>
                    <measurement group_id="O4" value="9.6" lower_limit="5.7" upper_limit="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.0" lower_limit="12.2" upper_limit="22.6"/>
                    <measurement group_id="O2" value="18.2" lower_limit="13.4" upper_limit="23.8"/>
                    <measurement group_id="O3" value="16.4" lower_limit="11.3" upper_limit="22.6"/>
                    <measurement group_id="O4" value="21.5" lower_limit="15.9" upper_limit="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="18.5" upper_limit="30.2"/>
                    <measurement group_id="O2" value="29.1" lower_limit="23.4" upper_limit="35.3"/>
                    <measurement group_id="O3" value="28.1" lower_limit="21.8" upper_limit="35.2"/>
                    <measurement group_id="O4" value="31.1" lower_limit="24.6" upper_limit="38.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.6" lower_limit="21.8" upper_limit="33.9"/>
                    <measurement group_id="O2" value="36.0" lower_limit="29.9" upper_limit="42.4"/>
                    <measurement group_id="O3" value="32.3" lower_limit="25.7" upper_limit="39.4"/>
                    <measurement group_id="O4" value="42.0" lower_limit="34.9" upper_limit="49.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1" lower_limit="31.7" upper_limit="44.7"/>
                    <measurement group_id="O2" value="48.8" lower_limit="42.3" upper_limit="55.3"/>
                    <measurement group_id="O3" value="44.7" lower_limit="37.5" upper_limit="52.1"/>
                    <measurement group_id="O4" value="51.8" lower_limit="44.5" upper_limit="59.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.0" lower_limit="38.5" upper_limit="51.7"/>
                    <measurement group_id="O2" value="58.9" lower_limit="52.4" upper_limit="65.2"/>
                    <measurement group_id="O3" value="51.3" lower_limit="44.0" upper_limit="58.6"/>
                    <measurement group_id="O4" value="56.9" lower_limit="49.7" upper_limit="64.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.4" lower_limit="54.8" upper_limit="67.7"/>
                    <measurement group_id="O2" value="70.1" lower_limit="36.9" upper_limit="75.8"/>
                    <measurement group_id="O3" value="61.5" lower_limit="54.2" upper_limit="68.4"/>
                    <measurement group_id="O4" value="75.6" lower_limit="69.0" upper_limit="81.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.8" lower_limit="78.4" upper_limit="88.2"/>
                    <measurement group_id="O2" value="86.4" lower_limit="81.4" upper_limit="90.4"/>
                    <measurement group_id="O3" value="86.7" lower_limit="81.1" upper_limit="91.1"/>
                    <measurement group_id="O4" value="91.0" lower_limit="86.1" upper_limit="94.6"/>
                  </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>Change in functional disability score at 2, 4, and 24 hours postdose compared between DFN-15 and placebo. 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>Change in functional disability score at 2, 4, and 24 hours postdose compared between DFN-15 and placebo. 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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </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="0.95"/>
                    <measurement group_id="O2" value="-0.9" spread="0.89"/>
                    <measurement group_id="O3" value="-0.6" spread="0.94"/>
                    <measurement group_id="O4" value="-0.9" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="1.06"/>
                    <measurement group_id="O2" value="-1.2" spread="0.89"/>
                    <measurement group_id="O3" value="-0.9" spread="0.97"/>
                    <measurement group_id="O4" value="-1.2" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="0.92"/>
                    <measurement group_id="O2" value="-1.7" spread="0.78"/>
                    <measurement group_id="O3" value="-1.5" spread="0.84"/>
                    <measurement group_id="O4" value="-1.7" spread="0.82"/>
                  </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 compared between DFN-15 and placebo, among those reporting cutaneous allodynia predose</description>
        <time_frame>2 and 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 compared between DFN-15 and placebo, among those reporting cutaneous allodynia predose</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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" lower_limit="16.0" upper_limit="38.5"/>
                    <measurement group_id="O2" value="26.2" lower_limit="15.8" upper_limit="39.1"/>
                    <measurement group_id="O3" value="25.5" lower_limit="14.3" upper_limit="39.6"/>
                    <measurement group_id="O4" value="39.5" lower_limit="25.0" upper_limit="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours postdose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.9" lower_limit="26.2" upper_limit="50.7"/>
                    <measurement group_id="O2" value="39.3" lower_limit="27.1" upper_limit="52.7"/>
                    <measurement group_id="O3" value="43.1" lower_limit="29.3" upper_limit="57.8"/>
                    <measurement group_id="O4" value="54.5" lower_limit="38.8" upper_limit="69.6"/>
                  </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, and whose BMI was &lt; 25 kg/m2 vs. subjects whose BMI was ≥ 25 kg/m2</description>
        <time_frame>2 and 4 hours postdose</time_frame>
        <population>Subjects were stratified and data were evaluated by subject BMI, therefore the overall number analyzed differs from the participant numbers reported in the data table.</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, and whose BMI was &lt; 25 kg/m2 vs. subjects whose BMI was ≥ 25 kg/m2</description>
          <population>Subjects were stratified and data were evaluated by subject BMI, therefore the overall number analyzed differs from the participant numbers reported in the data table.</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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </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="144"/>
                    <count group_id="O2" value="156"/>
                    <count group_id="O3" value="122"/>
                    <count group_id="O4" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" lower_limit="16.3" upper_limit="30.7"/>
                    <measurement group_id="O2" value="25.6" lower_limit="19.0" upper_limit="33.2"/>
                    <measurement group_id="O3" value="22.1" lower_limit="15.1" upper_limit="30.5"/>
                    <measurement group_id="O4" value="34.3" lower_limit="26.5" upper_limit="42.8"/>
                  </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="147"/>
                    <count group_id="O2" value="156"/>
                    <count group_id="O3" value="122"/>
                    <count group_id="O4" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1" lower_limit="30.2" upper_limit="46.5"/>
                    <measurement group_id="O2" value="43.6" lower_limit="35.7" upper_limit="51.8"/>
                    <measurement group_id="O3" value="44.3" lower_limit="35.3" upper_limit="53.5"/>
                    <measurement group_id="O4" value="55.0" lower_limit="46.4" upper_limit="63.4"/>
                  </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="123"/>
                    <count group_id="O2" value="124"/>
                    <count group_id="O3" value="117"/>
                    <count group_id="O4" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3" lower_limit="21.4" upper_limit="38.1"/>
                    <measurement group_id="O2" value="41.9" lower_limit="33.1" upper_limit="51.1"/>
                    <measurement group_id="O3" value="26.5" lower_limit="18.8" upper_limit="35.5"/>
                    <measurement group_id="O4" value="40.0" lower_limit="30.3" upper_limit="50.3"/>
                  </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="124"/>
                    <count group_id="O2" value="125"/>
                    <count group_id="O3" value="118"/>
                    <count group_id="O4" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" lower_limit="33.9" upper_limit="51.9"/>
                    <measurement group_id="O2" value="56.0" lower_limit="46.8" upper_limit="64.9"/>
                    <measurement group_id="O3" value="49.2" lower_limit="39.8" upper_limit="58.5"/>
                    <measurement group_id="O4" value="64.7" lower_limit="54.6" upper_limit="73.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Headache Pain Recurrence Postdose (DB1 and DB2)</title>
        <description>The percentage of subjects who had pain recurrence between 2 to 24 hours (i.e., pain-free at 2 hours postdose, with pain [mild, moderate, or severe] reported at 24 hours postdose) compared between DFN-15 and placebo</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>The percentage of subjects who had pain recurrence between 2 to 24 hours (i.e., pain-free at 2 hours postdose, with pain [mild, moderate, or severe] reported at 24 hours postdose) compared between DFN-15 and placebo</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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" lower_limit="4.2" upper_limit="19.8"/>
                    <measurement group_id="O2" value="7.6" lower_limit="3.1" upper_limit="15.1"/>
                    <measurement group_id="O3" value="6.9" lower_limit="1.9" upper_limit="16.7"/>
                    <measurement group_id="O4" value="4.5" lower_limit="1.3" upper_limit="11.1"/>
                  </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>The percentage of the population of subjects who reported headache pain relief between 2 and 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>The percentage of the population of subjects who reported headache pain relief between 2 and 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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.8" lower_limit="33.0" upper_limit="46.9"/>
                    <measurement group_id="O2" value="55.1" lower_limit="48.4" upper_limit="61.7"/>
                    <measurement group_id="O3" value="44.3" lower_limit="37.0" upper_limit="51.8"/>
                    <measurement group_id="O4" value="56.6" lower_limit="49.1" upper_limit="63.9"/>
                  </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>The percentage of subjects who had sustained pain freedom at 2 to 24 hours postdose compared between DFN-15 and placebo in each DB period. Sustained pain freedom at 2 to 24 hours postdose is 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</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>The percentage of subjects who had sustained pain freedom at 2 to 24 hours postdose compared between DFN-15 and placebo in each DB period. Sustained pain freedom at 2 to 24 hours postdose is 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</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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" lower_limit="13.7" upper_limit="25.0"/>
                    <measurement group_id="O2" value="27.6" lower_limit="21.8" upper_limit="33.9"/>
                    <measurement group_id="O3" value="20.0" lower_limit="14.5" upper_limit="26.5"/>
                    <measurement group_id="O4" value="29.1" lower_limit="22.6" upper_limit="36.3"/>
                  </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 medication 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 medication 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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5" lower_limit="23.2" upper_limit="34.2"/>
                    <measurement group_id="O2" value="18.8" lower_limit="14.4" upper_limit="23.9"/>
                    <measurement group_id="O3" value="22.9" lower_limit="17.8" upper_limit="28.6"/>
                    <measurement group_id="O4" value="18.4" lower_limit="13.7" upper_limit="23.8"/>
                  </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 and 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="253"/>
                <count group_id="O4" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Difference at 2 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="2.49"/>
                    <measurement group_id="O2" value="-0.1" spread="2.35"/>
                    <measurement group_id="O3" value="0.3" spread="2.45"/>
                    <measurement group_id="O4" value="-0.1" spread="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference at 4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="2.50"/>
                    <measurement group_id="O2" value="-0.1" spread="2.36"/>
                    <measurement group_id="O3" value="0.4" spread="2.46"/>
                    <measurement group_id="O4" value="-0.1" spread="2.29"/>
                  </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="287"/>
                <count group_id="O3" value="253"/>
                <count group_id="O4" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.866" spread="32.6258"/>
                    <measurement group_id="O2" value="5.112" spread="30.638"/>
                    <measurement group_id="O3" value="0.491" spread="32.5487"/>
                    <measurement group_id="O4" value="6.691" spread="28.1563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Raw Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.463" spread="12.7476"/>
                    <measurement group_id="O2" value="-1.498" spread="12.0209"/>
                    <measurement group_id="O3" value="0.426" spread="12.8385"/>
                    <measurement group_id="O4" value="-2.312" spread="11.0429"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.591" spread="41.0822"/>
                    <measurement group_id="O2" value="3.016" spread="38.9173"/>
                    <measurement group_id="O3" value="-3.261" spread="41.6631"/>
                    <measurement group_id="O4" value="6.044" spread="36.1736"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.812" spread="42.0995"/>
                    <measurement group_id="O2" value="8.554" spread="39.4248"/>
                    <measurement group_id="O3" value="2.559" spread="42.3773"/>
                    <measurement group_id="O4" value="10.708" spread="35.2324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.197" spread="29.1309"/>
                    <measurement group_id="O2" value="3.766" spread="26.0805"/>
                    <measurement group_id="O3" value="2.174" spread="27.7924"/>
                    <measurement group_id="O4" value="3.360" spread="23.7033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tolerability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.09" spread="14.850"/>
                    <measurement group_id="O2" value="6.98" spread="15.267"/>
                    <measurement group_id="O3" value="5.87" spread="14.115"/>
                    <measurement group_id="O4" value="7.62" spread="17.579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medication effectiveness (Global Item)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="2.80"/>
                    <measurement group_id="O2" value="0.1" spread="2.64"/>
                    <measurement group_id="O3" value="0.6" spread="2.65"/>
                    <measurement group_id="O4" value="-0.1" spread="2.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Side Effects (Global Item)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="2.00"/>
                    <measurement group_id="O2" value="-0.4" spread="1.88"/>
                    <measurement group_id="O3" value="-0.2" spread="1.98"/>
                    <measurement group_id="O4" value="-0.5" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Satisfaction (Global Item)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="2.74"/>
                    <measurement group_id="O2" value="0.1" spread="2.60"/>
                    <measurement group_id="O3" value="0.5" spread="2.65"/>
                    <measurement group_id="O4" value="-0.1" spread="2.41"/>
                  </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 during DB1</description>
        </group>
        <group group_id="E2">
          <title>DFN-15 DB1</title>
          <description>TEAEs that occurred following DFN-15 dose during DB1</description>
        </group>
        <group group_id="E3">
          <title>Placebo DB2</title>
          <description>TEAEs that occurred following placebo dose during DB2</description>
        </group>
        <group group_id="E4">
          <title>DFN-15 DB2</title>
          <description>TEAEs that occurred following DFN-15 dose during 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="283"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="283"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="289"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="572"/>
              </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="283"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="283"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="251"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="283"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="289"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="251"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="572"/>
              </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="5" subjects_at_risk="283"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="289"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="251"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="572"/>
              </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="283"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="289"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="254"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="251"/>
                <counts group_id="E5" events="16" subjects_affected="13" subjects_at_risk="572"/>
              </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>Director, Scientific Communications</name_or_title>
      <organization>BioDelivery Sciences (a subsidiary of Collegium Pharmaceutical)</organization>
      <phone>913-940-1789</phone>
      <email>tkunkel@collegiumpharma.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/NCT03009019
org study id: DFN-15-CD-006
nct id: NCT03009019
lead sponsor: 
collaborator: 
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 (First Treated Double-blind Treatment Period)
time frame: 2 hours postdose
description: The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0]
measure: Percentage of Subjects Who Are Free From Their MBS at 2 Hours Postdose
time frame: 2 hours postdose
description: Percentage of subjects who are free from their Most Bothersome Symptom (MBS) among nausea, photophobia, and phonophobia (first double-blind treatment period)
measure: The Number of Subjects With TEAEs After Study Drug Compared Between DFN-15 and Placebo
time frame: Per protocol, the maximum dosing timeframe for DB2 was 10 weeks; therefore, the maximum AE collection window was 11 weeks total.
description: 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.
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.
measure: Freedom From Nausea, Photophobia, and Phonophobia Postdose (DB1 and DB2)
time frame: 15 minutes to 24 hours postdose
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 compared between DFN-15 and placebo
measure: Time to Headache Pain Relief Postdose (DB1 and DB2)
time frame: 2 hours postdose
description: The time to headache pain relief was defined as the time in minutes from when a subject took study drug until the time pain relief was indicated by the subject in the eDiary within 2 hours postdose.
measure: Time to Headache Pain Freedom Postdose (DB1 and DB2)
time frame: 2 hours postdose
description: The time to headache pain freedom was defined as the time in minutes from when a subject took study drug until the time pain freedom was indicated by the subject in the eDiary within 2 hours postdose.
measure: Headache Pain Relief Postdose (DB1 and DB2)
time frame: 15 minutes to 24 hours postdose
description: Headache pain relief was defined for DB1 as a reduction from moderate or severe pain before dosing to mild or none postdose, and for DB2 as moderate or severe pain before dosing reduced to mild or none postdose, or mild pain before dosing reduced to none postdose. Data are reported by percentage reporting headache pain relief over time postdose.
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 period), 4, and 24 hours postdose compared between DFN-15 and placebo
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 Symptom) absent at 15, 30, and 45 minutes and 1, 1.5, 2 (DB2 period), 4, and 24 hours postdose compared between DFN-15 and placebo.
measure: Change in Functional Disability Score Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: Change in functional disability score at 2, 4, and 24 hours postdose compared between DFN-15 and placebo. 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 and 4 hours postdose
description: The percentage of subjects who were pain-free at 2 and 4 hours postdose compared between DFN-15 and placebo, among those reporting cutaneous allodynia predose
measure: Headache Pain Freedom Among BMI Category (DB1 and DB2)
time frame: 2 and 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, and whose BMI was < 25 kg/m2 vs. subjects whose BMI was ≥ 25 kg/m2
measure: Headache Pain Recurrence Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: The percentage of subjects who had pain recurrence between 2 to 24 hours (i.e., pain-free at 2 hours postdose, with pain [mild, moderate, or severe] reported at 24 hours postdose) compared between DFN-15 and placebo
measure: Sustained Headache Pain Relief Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: The percentage of the population of subjects who reported headache pain relief between 2 and 24 hours postdose.
measure: Sustained Headache Pain Freedom Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: The percentage of subjects who had sustained pain freedom at 2 to 24 hours postdose compared between DFN-15 and placebo in each DB period. Sustained pain freedom at 2 to 24 hours postdose is 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
measure: Use of Rescue Medication Postdose (DB1 and DB2)
time frame: 2 to 24 hours postdose
description: The percentage of subjects who used rescue medication 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 and 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/34447267/
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: 