<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/NCT04492020</url>
  </required_header>
  <id_info>
    <org_study_id>3110-304-002</org_study_id>
    <nct_id>NCT04492020</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants</brief_title>
  <acronym>UBR Prodrome</acronym>
  <official_title>A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute&#xD;
      Treatment of Migraine When Administered During the Prodrome&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2020</start_date>
  <completion_date type="Actual">April 19, 2022</completion_date>
  <primary_completion_date type="Actual">April 19, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose</measure>
    <time_frame>24 hours after taking double-blind study intervention during the prodrome</time_frame>
    <description>The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose</measure>
    <time_frame>48 hours after taking double-blind study intervention during the prodrome</time_frame>
    <description>The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose</measure>
    <time_frame>24 hours after taking double-blind study intervention during the prodrome</time_frame>
    <description>The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose</measure>
    <time_frame>24 hours after taking double-blind study intervention during the prodrome</time_frame>
    <description>The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">518</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Treatment Sequence A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ubrogepant 100 mg</intervention_name>
    <description>For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
    <arm_group_label>Treatment Sequence A</arm_group_label>
    <arm_group_label>Treatment Sequence B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
    <arm_group_label>Treatment Sequence A</arm_group_label>
    <arm_group_label>Treatment Sequence B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis&#xD;
             according to the ICHD-3 (International Classification of Headache Disorders 3rd&#xD;
             edition)&#xD;
&#xD;
          -  Migraine onset before age 50 years&#xD;
&#xD;
          -  By history, the participant's migraines typically last between 4 and 72 hours if&#xD;
             untreated or treated unsuccessfully and migraine episodes are separated by at least 48&#xD;
             hours of headache pain freedom&#xD;
&#xD;
          -  History of 2 to 8 migraine attacks per month with moderate to severe headache in each&#xD;
             of the 3 months prior to the Screening Visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficulty distinguishing migraine headache from tension-type or other headaches&#xD;
&#xD;
          -  Participants who overuse medication for migraine defined as use of opioids or&#xD;
             barbiturates &gt; 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics&#xD;
             (eg, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15&#xD;
             days/month in the 3 months prior to Visit 1 per investigator's judgment&#xD;
&#xD;
          -  Has a history of migraine aura with diplopia or impairment of level of consciousness,&#xD;
             hemiplegic migraine, or retinal migraine as defined by ICHD-3&#xD;
&#xD;
          -  A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or&#xD;
             more headache days per month on average in the 6 months prior to Visit 1 in the&#xD;
             investigator's judgment. A headache day is defined as a day in which there was any&#xD;
             occurrence of a headache of a minimum duration of 2 hours or a headache of any&#xD;
             duration for which acute medication was taken&#xD;
&#xD;
          -  Has a current diagnosis of new persistent daily headache, trigeminal autonomic&#xD;
             cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3&#xD;
&#xD;
          -  Required hospital treatment of a migraine attack 3 or more times in the 6 months prior&#xD;
             to Visit 1&#xD;
&#xD;
          -  History of malignancy in the 5 years prior to Visit 1, except for adequately treated&#xD;
             basal cell or squamous cell skin cancer, or in situ cervical cancer&#xD;
&#xD;
          -  History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory&#xD;
             bowel disease) that, per investigator judgment, may affect the absorption or&#xD;
             metabolism of the study intervention; participants with prior gastric bariatric&#xD;
             interventions (eg, Lap Band) which have been reversed are not excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Achieve Clinical Research, LLC /ID# 237098</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barrow Neuro Institute /ID# 236775</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Clinical Research /ID# 238032</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Headache and Balance Center /ID# 236247</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Valley Research Center /ID# 236561</name>
      <address>
        <city>Imperial</city>
        <state>California</state>
        <zip>92251-9401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wr-Pri Llc /Id# 236007</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Excell Research, Inc /ID# 237721</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George J. Rederich M.D. Inc. /ID# 235769</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research /ID# 237570</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Springs Neurological Associates (CSNA) /ID# 236556</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Neurosciences Research, LLC /ID# 237426</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNS Healthcare - Jacksonville /ID# 238245</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256-6039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Awareness, Inc - Jupiter /ID# 236226</name>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458-7021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Clinical Research /ID# 236934</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sensible Healthcare /ID# 238090</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions, Inc /ID# 236608</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801-2986</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709-3113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida /ID# 234387</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ForCare Clinical Research /ID# 237092</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613-1244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute - Palm Beach /ID# 238193</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407-3209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroTrials Research Inc. /ID# 237365</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch Atlanta, LLC /ID# 237390</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research (Neurology) - Savannah /ID# 234371</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406-2758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Atlanta - Headlands LLC /ID# 234438</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281-9054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Trials /ID# 234968</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic Downtown /ID# 236959</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47713-1227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of McFarland /ID# 238271</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010-5733</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collective Medical Research /ID# 236402</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas Institute of Research /ID# 236738</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211-1363</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Clinical Trials /ID# 236559</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02131-2515</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Headache &amp; Neurological Institute (MHNI) /ID# 236565</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104-5131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Clinic of Neurology - Golden Valley /ID# 238162</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55422-4215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute, Inc /ID# 238301</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402-2606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>StudyMetrix Research /ID# 236457</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinvest Research LLC /ID# 237908</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princeton Center for Clinical Research /ID# 235734</name>
      <address>
        <city>Skillman</city>
        <state>New Jersey</state>
        <zip>08558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bio Behavioral Health, Inc /ID# 238212</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755-6434</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dent Neurosciences Research Center, Inc. /ID# 237039</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central New York Clinical Research /ID# 235694</name>
      <address>
        <city>Manlius</city>
        <state>New York</state>
        <zip>13104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Clinical Research /ID# 236842</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Clinical Research Associates /ID# 238220</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221-6046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Charlotte /ID# 237048</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raleigh Neurology Associates /ID# 237138</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTI Clinical Research Center /ID# 237278</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati /ID# 234403</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research Columbus /ID# 236837</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OK Clinical Research /ID# 236675</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73034-3257</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Research Company /ID# 237674</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Headlands LLC /ID# 236077</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Neurological Associates - Abington /ID# 236257</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Center for Clinical Research /ID# 236703</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104-5034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suburban Research Associates - Media /ID# 236698</name>
      <address>
        <city>Media</city>
        <state>Pennsylvania</state>
        <zip>19063-1760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Jefferson Headache Center /ID# 235821</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frontier Clinical Research /ID# 237924</name>
      <address>
        <city>Smithfield</city>
        <state>Pennsylvania</state>
        <zip>15478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of SC /ID# 237338</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WR-ClinSearch /ID# 238287</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421-1605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNS Healthcare - Memphis /ID# 236396</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Neurology /ID# 236428</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research, Inc. /ID# 237306</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DiscoveResearch, Inc /ID# 236273</name>
      <address>
        <city>Bryan</city>
        <state>Texas</state>
        <zip>77802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Dallas, LP /ID# 236276</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc. - Houston /ID# 237458</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinPoint Trials /ID# 236618</name>
      <address>
        <city>Waxahachie</city>
        <state>Texas</state>
        <zip>75165-1430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute /ID# 237749</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah /ID# 237602</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112-5500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research /ID# 237792</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tidewater Integr Med Research /ID# 236867</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Neurology Specialists - Virginia Beach /ID# 234350</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23456-0019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center /ID# 237585</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Clinical Research Center /ID# 236912</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Puget Sound Neurology /ID# 236322</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>25328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.allerganclinicaltrials.com/,http://www.investigatordatabank.org/</url>
    <description>Additional information on study locations near you may be found at www.AllerganClinicalTrials.com.</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <results_first_submitted>April 18, 2023</results_first_submitted>
  <results_first_submitted_qc>May 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 31, 2023</results_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migraine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing, please refer to the link below</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </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 2, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT04492020/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>May 10, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT04492020/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Sequence A</title>
          <description>Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event&#xD;
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours&#xD;
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
        </group>
        <group group_id="P2">
          <title>Treatment Sequence B</title>
          <description>Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event&#xD;
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours&#xD;
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="264"/>
                <participants group_id="P2" count="254"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="247"/>
                <participants group_id="P2" count="233"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="223"/>
                <participants group_id="P2" count="215"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Qualifying Event</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population consists of all treated participants who take at least 1 administration of study intervention</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Sequence A</title>
          <description>Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event&#xD;
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours&#xD;
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
        </group>
        <group group_id="B2">
          <title>Treatment Sequence B</title>
          <description>Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event&#xD;
Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours&#xD;
Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</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="247"/>
            <count group_id="B2" value="233"/>
            <count group_id="B3" value="480"/>
          </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="41.7" spread="12.63"/>
                    <measurement group_id="B2" value="42.9" spread="13.10"/>
                    <measurement group_id="B3" value="42.3" spread="12.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 - 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 - 39</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40 - 49</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 - 59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 - 69</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 70</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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="216"/>
                    <measurement group_id="B2" value="205"/>
                    <measurement group_id="B3" value="421"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="59"/>
                  </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="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="229"/>
                    <measurement group_id="B2" value="216"/>
                    <measurement group_id="B3" value="445"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                    <measurement group_id="B2" value="209"/>
                    <measurement group_id="B3" value="423"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose</title>
        <description>The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.</description>
        <time_frame>24 hours after taking double-blind study intervention during the prodrome</time_frame>
        <population>The Modified Intent-to-Treat (mITT) population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
          </group>
          <group group_id="O2">
            <title>Ubrogepant 100 mg</title>
            <description>Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose</title>
          <description>The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.</description>
          <population>The Modified Intent-to-Treat (mITT) population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="423"/>
                <count group_id="O2" value="418"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                    <measurement group_id="O2" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>generalized linear mixed model (GLMM)</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.63</ci_lower_limit>
            <ci_upper_limit>2.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose</title>
        <description>The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache</description>
        <time_frame>48 hours after taking double-blind study intervention during the prodrome</time_frame>
        <population>The Modified Intent-to-Treat (mITT) population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
          </group>
          <group group_id="O2">
            <title>Ubrogepant 100 mg</title>
            <description>Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose</title>
          <description>The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache</description>
          <population>The Modified Intent-to-Treat (mITT) population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="407"/>
                <count group_id="O2" value="391"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>generalized linear mixed model (GLMM)</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.63</ci_lower_limit>
            <ci_upper_limit>2.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose</title>
        <description>The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome</description>
        <time_frame>24 hours after taking double-blind study intervention during the prodrome</time_frame>
        <population>Modified Intent-to-Treat Population (randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period) with non-missing ability to function normally assessment at each timepoint after dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
          </group>
          <group group_id="O2">
            <title>Ubrogepant 100 mg</title>
            <description>Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose</title>
          <description>The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome</description>
          <population>Modified Intent-to-Treat Population (randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period) with non-missing ability to function normally assessment at each timepoint after dose.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="449"/>
                <count group_id="O2" value="448"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 Hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="432"/>
                    <count group_id="O2" value="418"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonresponder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="336"/>
                    <measurement group_id="O2" value="311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="421"/>
                    <count group_id="O2" value="422"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonresponder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="311"/>
                    <measurement group_id="O2" value="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="419"/>
                    <count group_id="O2" value="412"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                    <measurement group_id="O2" value="199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonresponder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="269"/>
                    <measurement group_id="O2" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="417"/>
                    <count group_id="O2" value="415"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                    <measurement group_id="O2" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonresponder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="244"/>
                    <measurement group_id="O2" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="400"/>
                    <count group_id="O2" value="395"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="210"/>
                    <measurement group_id="O2" value="266"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonresponder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="190"/>
                    <measurement group_id="O2" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="394"/>
                    <count group_id="O2" value="388"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="239"/>
                    <measurement group_id="O2" value="291"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonresponder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                    <measurement group_id="O2" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="404"/>
                    <count group_id="O2" value="413"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="342"/>
                    <measurement group_id="O2" value="367"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nonresponder</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>generalized estimating equation (GEE)</method>
            <param_type>Geometric Mean Odds Ratio</param_type>
            <param_value>1.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.40</ci_lower_limit>
            <ci_upper_limit>1.96</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose</title>
        <description>The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.</description>
        <time_frame>24 hours after taking double-blind study intervention during the prodrome</time_frame>
        <population>The Modified Intent-to-Treat (mITT) population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
          </group>
          <group group_id="O2">
            <title>Ubrogepant 100 mg</title>
            <description>Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose</title>
          <description>The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.</description>
          <population>The Modified Intent-to-Treat (mITT) population consists of all randomized participants with at least 1 assessment of headache occurrence within 24 hours after taking double-blind study intervention for at least 1 qualifying prodrome event during the double-blind treatment period</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="439"/>
                <count group_id="O2" value="434"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>generalized linear mixed model (GLMM)</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.39</ci_lower_limit>
            <ci_upper_limit>2.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose through 30 days after the last dose of study drug (approximately 30 days)</time_frame>
      <desc>Safety Population, all treated participants who take ≥1 administration of study intervention. Participants will be summarized according to the study intervention they actually received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
        </group>
        <group group_id="E2">
          <title>Ubrogepant 100 mg</title>
          <description>Ubrogepant 100mg: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <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="462"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="456"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="462"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="456"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>RHABDOMYOLYSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="462"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="456"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="462"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="456"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="462"/>
                <counts group_id="E2" events="25" subjects_affected="24" subjects_at_risk="456"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="462"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="456"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="462"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="456"/>
              </event>
              <event>
                <sub_title>SOMNOLENCE</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="462"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="456"/>
              </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>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT04492020
org study id: 3110-304-002
nct id: NCT04492020
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute
      Treatment of Migraine When Administered During the Prodrome
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose
time frame: 24 hours after taking double-blind study intervention during the prodrome
description: The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
measure: Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose
time frame: 48 hours after taking double-blind study intervention during the prodrome
description: The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache
measure: Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
time frame: 24 hours after taking double-blind study intervention during the prodrome
description: The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome
measure: Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose
time frame: 24 hours after taking double-blind study intervention during the prodrome
description: The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
arm group label: Treatment Sequence A
arm group type: Experimental
description: Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event
arm group label: Treatment Sequence B
arm group type: Experimental
description: Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event
intervention type: Drug
intervention name: Ubrogepant 100 mg
description: For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
arm group label: Treatment Sequence A
arm group label: Treatment Sequence B
intervention type: Drug
intervention name: Placebo
description: For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
arm group label: Treatment Sequence A
arm group label: Treatment Sequence B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: United States
url: https://www.allerganclinicaltrials.com/,http://www.investigatordatabank.org/
description: Additional information on study locations near you may be found at www.AllerganClinicalTrials.com.
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing, please refer to the link below
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://vivli.org/ourmember/abbvie/
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