<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/NCT03777059</url>
  </required_header>
  <id_info>
    <org_study_id>3101-301-002</org_study_id>
    <nct_id>NCT03777059</nct_id>
  </id_info>
  <brief_title>12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine</brief_title>
  <official_title>A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (ADVANCE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the&#xD;
      prevention of migraine in participants with episodic migraine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">June 19, 2020</completion_date>
  <primary_completion_date type="Actual">June 19, 2020</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period</measure>
    <time_frame>Baseline (Day -28 to Day -1) to Week 12</time_frame>
    <description>Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period</measure>
    <time_frame>Baseline (Day-28 to Day -1) to Week 12</time_frame>
    <description>Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period</measure>
    <time_frame>Baseline (Day-28 to Day -1) to Week 12</time_frame>
    <description>Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days</measure>
    <time_frame>Baseline (Day -28 to Day -1) to Week 12</time_frame>
    <description>Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12</measure>
    <time_frame>Baseline (Day 1) to Week 12</time_frame>
    <description>MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period</measure>
    <time_frame>Baseline (Day -28 to Day -1) to Week 12</time_frame>
    <description>The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) performance of daily activities domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period</measure>
    <time_frame>Baseline (Day -28 to Day -1) to Week 12</time_frame>
    <description>The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) physical impairment domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">910</enrollment>
  <condition>Episodic Migraine</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atogepant 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atogepant 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atogepant 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atogepant</intervention_name>
    <description>Atogepant tablet</description>
    <arm_group_label>Atogepant 10 mg</arm_group_label>
    <arm_group_label>Atogepant 30 mg</arm_group_label>
    <arm_group_label>Atogepant 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo-matching atogepant tablets</description>
    <arm_group_label>Atogepant 10 mg</arm_group_label>
    <arm_group_label>Atogepant 30 mg</arm_group_label>
    <arm_group_label>Atogepant 60 mg</arm_group_label>
    <arm_group_label>Placebo</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&#xD;
             diagnosis.&#xD;
&#xD;
          -  Age of the participant at the time of migraine onset &lt;50 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a history of migraine accompanied by diplopia or decreased level of consciousness&#xD;
             or retinal migraine.&#xD;
&#xD;
          -  Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal&#xD;
             autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy.&#xD;
&#xD;
          -  History of an inadequate response to &gt;4 medications (2 of which have different&#xD;
             mechanisms of action) prescribed for the prevention of migraine.&#xD;
&#xD;
          -  Participants with clinically significant hematologic, endocrine, cardiovascular,&#xD;
             pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Trugman, MD</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Associates</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alea Research Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barrow Neurological Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange Grove Family Practice</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Principals Research Group</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Clinical Research</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health Center for Clinical Research</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med Center Medical Clinic</name>
      <address>
        <city>Carmichael</city>
        <state>California</state>
        <zip>95608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Triwest Research Associates</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro Pain Medical Center</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Headache and Balance Center</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fullerton Neurology and Headache Center</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Center of North Orange County</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NervePro Research Bruce Cleeremans</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grossmont Center for Clinical Research</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Clinical Research Institute, Inc.</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Beach Clinical Trials Services</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keck Medicine of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newport Beach Clinical Research Associates</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Excell Research, Inc.</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rancho Cucamonga Clinical Research</name>
      <address>
        <city>Rancho Cucamonga</city>
        <state>California</state>
        <zip>91730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Valley Research</name>
      <address>
        <city>Redlands</city>
        <state>California</state>
        <zip>92374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George J. Rederich, M.D. Inc.</name>
      <address>
        <city>Redondo Beach</city>
        <state>California</state>
        <zip>90277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paradigm Clinical Research Centers, Inc</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimus Medical Group</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Neuroscience Research</name>
      <address>
        <city>Sherman Oaks</city>
        <state>California</state>
        <zip>91403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Springs Neurological Associates</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delta Waves, Inc.</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Neurological Institute</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Institute for Clinical Research</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventura Neurological Associates</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Offices of South Florida</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33428</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarkis Clinical Trials- Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westside Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions, Inc.</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Associates, P.A.</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Well Pharma Medical Research, Corp.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Associates of Ormond Beach</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Hospital Clinical Research Center</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axiom Clinical Research of Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurotrials Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diamond Headache Clinic Ltd</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Specialists</name>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JWM Neurology</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deaconess Clinic - Gateway Health Center</name>
      <address>
        <city>Newburgh</city>
        <state>Indiana</state>
        <zip>47630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research, Inc. d/b/a PMG Research of McFarland Clinic</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>College Park Family Care Center</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Medical Research</name>
      <address>
        <city>Prairie Village</city>
        <state>Kansas</state>
        <zip>66208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC - An AMR Company</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC - An AMR Company</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Center for Clinical Research</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DelRicht Research</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmasite Research, Inc.</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Atlantic Permanente Medical Group, PC</name>
      <address>
        <city>Largo</city>
        <state>Maryland</state>
        <zip>20774</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John R. Graham Headache Center Brigham and Women's Faulkner Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BTC of New Bedford</name>
      <address>
        <city>New Bedford</city>
        <state>Massachusetts</state>
        <zip>02740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Clinic of Neurology</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Usa</name>
      <address>
        <city>Bay Saint Louis</city>
        <state>Mississippi</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Headache Center</name>
      <address>
        <city>Ridgeland</city>
        <state>Mississippi</state>
        <zip>39157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>StudyMetrix Research</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.</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nevada Headache Institute</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bio Behavioral Health</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albuquerque Clinical Trials</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dent Neurologic Institute</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Charlotte, LLC</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guilford Neurologic Associates, Inc</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raleigh Neurology Associates, P.A.</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Raleigh, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Rocky Mount, LLC</name>
      <address>
        <city>Rocky Mount</city>
        <state>North Carolina</state>
        <zip>27804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmington Health, PLLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Medical Research of Winston-Salem</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTI Clinical Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Patient Priority Clinical Sites</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentral Clinical Research Services</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research Inc</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Physicians Associates</name>
      <address>
        <city>Lyndhurst</city>
        <state>Ohio</state>
        <zip>44124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OK Clinical Research, LLC</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Institute of Norman</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centennial Health-Synexus</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulsa Clinical Research</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Center for Clinical Investigations</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preferred Primary Care Physicians</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frontier Clinical Research, LLC</name>
      <address>
        <city>Smithfield</city>
        <state>Pennsylvania</state>
        <zip>15478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preferred Primary Care Physicians, Jacob Murphy</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Neurological Associates</name>
      <address>
        <city>Willow Grove</city>
        <state>Pennsylvania</state>
        <zip>19090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Partners in Clinical Research</name>
      <address>
        <city>Cumberland</city>
        <state>Rhode Island</state>
        <zip>02864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocean State Clinical Research Partners</name>
      <address>
        <city>Lincoln</city>
        <state>Rhode Island</state>
        <zip>02865</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Care Associates/Synexus Clinical</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillcrest Family Practice</name>
      <address>
        <city>Simpsonville</city>
        <state>South Carolina</state>
        <zip>29681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinSearch</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Medical Group</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNS Healthcare - Memphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatry &amp; Psychotherapy Partners Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78737</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus-US</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ventavia Research Group</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Protenium Clinical Research</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinPoint Trials</name>
      <address>
        <city>Waxahachie</city>
        <state>Texas</state>
        <zip>75165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus-US</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc. / Foothill Family Clinic South</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highland Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc.</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research</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.</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical Research, Inc</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Family Medicine Physicians</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastside Therapeutic Resource and Core Clinical Research</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Polyclinic</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Puget Sound Neurology</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>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <results_first_submitted>June 18, 2021</results_first_submitted>
  <results_first_submitted_qc>June 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 9, 2021</results_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migraine</keyword>
  <keyword>Aura</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <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 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03777059/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>June 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03777059/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants diagnosed with episodic migraine were enrolled in one of 4 treatment arms: placebo, or atogepant 10 mg once daily (QD), 30 mg QD, 60 mg QD in Double-blind (DB) Treatment Period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Atogepant 10 mg</title>
          <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Atogepant 30 mg</title>
          <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Atogepant 60 mg</title>
          <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>DB Treatment Period (Up to Week 12)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="223"/>
                <participants group_id="P2" count="222"/>
                <participants group_id="P3" count="230"/>
                <participants group_id="P4" count="235"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated: Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="222"/>
                <participants group_id="P2" count="221"/>
                <participants group_id="P3" count="228"/>
                <participants group_id="P4" count="231"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="201"/>
                <participants group_id="P2" count="193"/>
                <participants group_id="P3" count="207"/>
                <participants group_id="P4" count="204"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-Up Period (Weeks 12 to 16)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="38"/>
                <participants group_id="P4" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population included all participants who received at least 1 dose of study intervention.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Atogepant 10 mg</title>
          <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Atogepant 30 mg</title>
          <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Atogepant 60 mg</title>
          <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="B5">
          <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="222"/>
            <count group_id="B2" value="221"/>
            <count group_id="B3" value="228"/>
            <count group_id="B4" value="231"/>
            <count group_id="B5" value="902"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="222"/>
                    <count group_id="B2" value="221"/>
                    <count group_id="B3" value="228"/>
                    <count group_id="B4" value="231"/>
                    <count group_id="B5" value="902"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.3" spread="12.81"/>
                    <measurement group_id="B2" value="41.4" spread="12.05"/>
                    <measurement group_id="B3" value="42.1" spread="11.68"/>
                    <measurement group_id="B4" value="42.5" spread="12.41"/>
                    <measurement group_id="B5" value="41.6" spread="12.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="222"/>
                    <count group_id="B2" value="221"/>
                    <count group_id="B3" value="228"/>
                    <count group_id="B4" value="231"/>
                    <count group_id="B5" value="902"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="198"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="204"/>
                    <measurement group_id="B4" value="199"/>
                    <measurement group_id="B5" value="801"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="101"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="222"/>
                    <count group_id="B2" value="221"/>
                    <count group_id="B3" value="228"/>
                    <count group_id="B4" value="231"/>
                    <count group_id="B5" value="902"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="12"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                    <measurement group_id="B2" value="181"/>
                    <measurement group_id="B3" value="185"/>
                    <measurement group_id="B4" value="192"/>
                    <measurement group_id="B5" value="752"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="222"/>
                    <count group_id="B2" value="221"/>
                    <count group_id="B3" value="228"/>
                    <count group_id="B4" value="231"/>
                    <count group_id="B5" value="902"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="199"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="209"/>
                    <measurement group_id="B4" value="217"/>
                    <measurement group_id="B5" value="825"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monthly Migraine Days</title>
          <description>A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.</population>
          <units>migraine days per month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="214"/>
                    <count group_id="B3" value="223"/>
                    <count group_id="B4" value="222"/>
                    <count group_id="B5" value="873"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.5" spread="2.39"/>
                    <measurement group_id="B2" value="7.5" spread="2.46"/>
                    <measurement group_id="B3" value="7.9" spread="2.32"/>
                    <measurement group_id="B4" value="7.8" spread="2.31"/>
                    <measurement group_id="B5" value="7.6" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monthly Headache Days</title>
          <description>A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.</population>
          <units>headache days per month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="214"/>
                    <count group_id="B3" value="223"/>
                    <count group_id="B4" value="222"/>
                    <count group_id="B5" value="873"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.4" spread="2.55"/>
                    <measurement group_id="B2" value="8.4" spread="2.75"/>
                    <measurement group_id="B3" value="8.8" spread="2.62"/>
                    <measurement group_id="B4" value="9.0" spread="2.56"/>
                    <measurement group_id="B5" value="8.7" spread="2.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monthly Acute Medication Use</title>
          <description>The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.</population>
          <units>acute medication use days per month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="214"/>
                    <count group_id="B2" value="214"/>
                    <count group_id="B3" value="223"/>
                    <count group_id="B4" value="222"/>
                    <count group_id="B5" value="873"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.5" spread="3.15"/>
                    <measurement group_id="B2" value="6.6" spread="2.99"/>
                    <measurement group_id="B3" value="6.7" spread="3.02"/>
                    <measurement group_id="B4" value="6.9" spread="3.17"/>
                    <measurement group_id="B5" value="6.7" spread="3.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MSQ v2.1 Role Function-Restrictive Domain Score</title>
          <description>Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) is 14-item questionnaire to measure health-related quality-of-life impairments attributed to migraine, divided in 3 domains: role function-restrictive: how migraines limit daily social and work-related activities; role function-preventive: how migraines prevent these activities; and emotional function domain: emotions associated with migraines, using a 6-point scale, 1=none of the time and 6=all of the time. Domain scores were rescaled from 0 to 100, with higher scores indicating better migraine specific quality of life.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Number analyzed is the number of participants available for the analyses at Baseline.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="213"/>
                    <count group_id="B2" value="212"/>
                    <count group_id="B3" value="222"/>
                    <count group_id="B4" value="222"/>
                    <count group_id="B5" value="869"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.8" spread="19.67"/>
                    <measurement group_id="B2" value="44.9" spread="21.37"/>
                    <measurement group_id="B3" value="44.0" spread="19.61"/>
                    <measurement group_id="B4" value="46.8" spread="20.36"/>
                    <measurement group_id="B5" value="45.6" spread="20.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Daily Activities Domain Score of the Activity Impairment in Migraine- Diary (AIM-D)</title>
          <description>AIM-D is a 9-item PRO measure that assesses the impact of migraine on performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine. Baseline was defined as the monthly (averaged for a month) scores during the last 28 days.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Number analyzed is the number of participants available for the analyses at Baseline.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="188"/>
                    <count group_id="B2" value="191"/>
                    <count group_id="B3" value="188"/>
                    <count group_id="B4" value="192"/>
                    <count group_id="B5" value="759"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.2" spread="8.25"/>
                    <measurement group_id="B2" value="15.5" spread="8.85"/>
                    <measurement group_id="B3" value="16.9" spread="8.02"/>
                    <measurement group_id="B4" value="15.9" spread="8.34"/>
                    <measurement group_id="B5" value="15.9" spread="8.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monthly Physical Impairment Domain Score of the AIM-D</title>
          <description>AIM-D is a 9-item PRO measure that assesses the impact of migraine on performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine. Baseline was defined as the monthly (averaged for a month) scores during the last 28 days.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Number analyzed is the number of participants available for the analyses at Baseline.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="188"/>
                    <count group_id="B2" value="191"/>
                    <count group_id="B3" value="188"/>
                    <count group_id="B4" value="192"/>
                    <count group_id="B5" value="759"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.2" spread="8.11"/>
                    <measurement group_id="B2" value="11.7" spread="8.46"/>
                    <measurement group_id="B3" value="13.0" spread="8.00"/>
                    <measurement group_id="B4" value="11.6" spread="7.85"/>
                    <measurement group_id="B5" value="11.9" spread="8.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period</title>
        <description>Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.</description>
        <time_frame>Baseline (Day -28 to Day -1) to Week 12</time_frame>
        <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Atogepant 10 mg</title>
            <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Atogepant 30 mg</title>
            <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Atogepant 60 mg</title>
            <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period</title>
          <description>Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.</population>
          <units>migraine days per month</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="223"/>
                <count group_id="O4" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.48" spread="0.210"/>
                    <measurement group_id="O2" value="-3.69" spread="0.210"/>
                    <measurement group_id="O3" value="-3.86" spread="0.206"/>
                    <measurement group_id="O4" value="-4.20" spread="0.206"/>
                  </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>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.291</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.78</ci_lower_limit>
            <ci_upper_limit>-0.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.287</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.94</ci_lower_limit>
            <ci_upper_limit>-0.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.288</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.28</ci_lower_limit>
            <ci_upper_limit>-1.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period</title>
        <description>Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis.</description>
        <time_frame>Baseline (Day-28 to Day -1) to Week 12</time_frame>
        <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Atogepant 10 mg</title>
            <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Atogepant 30 mg</title>
            <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Atogepant 60 mg</title>
            <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period</title>
          <description>Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.</population>
          <units>headache days per month</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="223"/>
                <count group_id="O4" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.52" spread="0.225"/>
                    <measurement group_id="O2" value="-3.94" spread="0.225"/>
                    <measurement group_id="O3" value="-4.04" spread="0.221"/>
                    <measurement group_id="O4" value="-4.23" spread="0.221"/>
                  </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>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.42</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.311</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.03</ci_lower_limit>
            <ci_upper_limit>-0.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.307</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.13</ci_lower_limit>
            <ci_upper_limit>-0.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.71</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.309</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.32</ci_lower_limit>
            <ci_upper_limit>-1.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period</title>
        <description>Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.</description>
        <time_frame>Baseline (Day-28 to Day -1) to Week 12</time_frame>
        <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Atogepant 10 mg</title>
            <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Atogepant 30 mg</title>
            <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Atogepant 60 mg</title>
            <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period</title>
          <description>Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period.</population>
          <units>acute medication use days per month</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="223"/>
                <count group_id="O4" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.35" spread="0.184"/>
                    <measurement group_id="O2" value="-3.66" spread="0.183"/>
                    <measurement group_id="O3" value="-3.68" spread="0.180"/>
                    <measurement group_id="O4" value="-3.85" spread="0.180"/>
                  </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>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.254</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.81</ci_lower_limit>
            <ci_upper_limit>-0.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.251</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.82</ci_lower_limit>
            <ci_upper_limit>-0.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.252</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.00</ci_lower_limit>
            <ci_upper_limit>-1.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days</title>
        <description>Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.</description>
        <time_frame>Baseline (Day -28 to Day -1) to Week 12</time_frame>
        <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period (Day -28 to Day -1) of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1-4, 5-8, and 9-12) of eDiary data during the Double-blind Treatment Period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Atogepant 10 mg</title>
            <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Atogepant 30 mg</title>
            <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Atogepant 60 mg</title>
            <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days</title>
          <description>Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period (Day -28 to Day -1) of eDiary data, and had at least 1 evaluable post-baseline 4-week period (Weeks 1-4, 5-8, and 9-12) of eDiary data during the Double-blind Treatment Period.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="214"/>
                <count group_id="O3" value="223"/>
                <count group_id="O4" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0"/>
                    <measurement group_id="O2" value="55.6"/>
                    <measurement group_id="O3" value="58.7"/>
                    <measurement group_id="O4" value="60.8"/>
                  </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>&lt;.0001</p_value>
            <p_value_desc>Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.05</ci_lower_limit>
            <ci_upper_limit>4.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.37</ci_lower_limit>
            <ci_upper_limit>5.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.56</ci_lower_limit>
            <ci_upper_limit>5.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12</title>
        <description>MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis.</description>
        <time_frame>Baseline (Day 1) to Week 12</time_frame>
        <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Overall number analyzed is the number of participants with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Atogepant 10 mg</title>
            <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Atogepant 30 mg</title>
            <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Atogepant 60 mg</title>
            <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12</title>
          <description>MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Overall number analyzed is the number of participants with data available for analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="186"/>
                <count group_id="O3" value="203"/>
                <count group_id="O4" value="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.45" spread="1.617"/>
                    <measurement group_id="O2" value="30.35" spread="1.639"/>
                    <measurement group_id="O3" value="30.53" spread="1.593"/>
                    <measurement group_id="O4" value="31.25" spread="1.591"/>
                  </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>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>9.90</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.270</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.45</ci_lower_limit>
            <ci_upper_limit>14.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>10.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.229</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.71</ci_lower_limit>
            <ci_upper_limit>14.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>10.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.231</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.42</ci_lower_limit>
            <ci_upper_limit>15.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period</title>
        <description>The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) performance of daily activities domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.</description>
        <time_frame>Baseline (Day -28 to Day -1) to Week 12</time_frame>
        <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Overall number analyzed is the number of participants with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Atogepant 10 mg</title>
            <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Atogepant 30 mg</title>
            <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Atogepant 60 mg</title>
            <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period</title>
          <description>The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) performance of daily activities domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Overall number analyzed is the number of participants with data available for analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.09" spread="0.504"/>
                    <measurement group_id="O2" value="-7.28" spread="0.500"/>
                    <measurement group_id="O3" value="-8.63" spread="0.502"/>
                    <measurement group_id="O4" value="-9.41" spread="0.504"/>
                  </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>0.0856</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.693</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.56</ci_lower_limit>
            <ci_upper_limit>0.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-2.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.694</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.91</ci_lower_limit>
            <ci_upper_limit>-1.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-3.32</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.694</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.68</ci_lower_limit>
            <ci_upper_limit>-1.96</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period</title>
        <description>The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) physical impairment domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.</description>
        <time_frame>Baseline (Day -28 to Day -1) to Week 12</time_frame>
        <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Overall number analyzed is the number of participants with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Atogepant 10 mg</title>
            <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Atogepant 30 mg</title>
            <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Atogepant 60 mg</title>
            <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period</title>
          <description>The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) physical impairment domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.</description>
          <population>mITT Population included all randomized participants who received at least 1 dose of study intervention, had an evaluable Baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the Double-blind Treatment Period. Overall number analyzed is the number of participants with data available for analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.03" spread="0.439"/>
                    <measurement group_id="O2" value="-5.11" spread="0.436"/>
                    <measurement group_id="O3" value="-6.02" spread="0.438"/>
                    <measurement group_id="O4" value="-6.49" spread="0.439"/>
                  </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>0.0743</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.605</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.27</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0011</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-1.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.606</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.18</ci_lower_limit>
            <ci_upper_limit>-0.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.</p_value_desc>
            <method>Mixed-effects Model for Repeated Measure</method>
            <param_type>Least Squares Mean Difference</param_type>
            <param_value>-2.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.605</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.65</ci_lower_limit>
            <ci_upper_limit>-1.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug through end of study (Up to 16 weeks)</time_frame>
      <desc>All-Cause Mortality is reported for all randomized participants. Safety Population, all participants who received at least 1 dose of study intervention, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Atogepant 10 mg</title>
          <description>Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Atogepant 30 mg</title>
          <description>Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Atogepant 60 mg</title>
          <description>Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA: 22.0</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="223"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="230"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="235"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="231"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="231"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="231"/>
              </event>
              <event>
                <sub_title>Optic neuritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="231"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="231"/>
              </event>
              <event>
                <sub_title>Negative pressure pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="231"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA: 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="37" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="32" subjects_at_risk="231"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="231"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="231"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="222"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="221"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="228"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="231"/>
              </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>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area, Head</name_or_title>
      <organization>Allergan</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.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/NCT03777059
org study id: 3101-301-002
nct id: NCT03777059
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the
      prevention of migraine in participants with episodic migraine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period
time frame: Baseline (Day -28 to Day -1) to Week 12
description: Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.
measure: Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period
time frame: Baseline (Day-28 to Day -1) to Week 12
description: Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis.
measure: Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period
time frame: Baseline (Day-28 to Day -1) to Week 12
description: Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.
measure: Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days
time frame: Baseline (Day -28 to Day -1) to Week 12
description: Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.
measure: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12
time frame: Baseline (Day 1) to Week 12
description: MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis.
measure: Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period
time frame: Baseline (Day -28 to Day -1) to Week 12
description: The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) performance of daily activities domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.
measure: Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period
time frame: Baseline (Day -28 to Day -1) to Week 12
description: The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) physical impairment domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo-matching atogepant tablets orally once daily for 12 weeks.
arm group label: Atogepant 10 mg
arm group type: Experimental
description: Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
arm group label: Atogepant 30 mg
arm group type: Experimental
description: Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
arm group label: Atogepant 60 mg
arm group type: Experimental
description: Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
intervention type: Drug
intervention name: Atogepant
description: Atogepant tablet
arm group label: Atogepant 10 mg
arm group label: Atogepant 30 mg
arm group label: Atogepant 60 mg
intervention type: Drug
intervention name: Placebo
description: Placebo-matching atogepant tablets
arm group label: Atogepant 10 mg
arm group label: Atogepant 30 mg
arm group label: Atogepant 60 mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Joel Trugman, MD
role: Study Director
affiliation: Allergan
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country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
provided document: 
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certain agreements: 
point of contact: 