<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/NCT04437433</url>
  </required_header>
  <id_info>
    <org_study_id>3101-306-002</org_study_id>
    <nct_id>NCT04437433</nct_id>
  </id_info>
  <brief_title>A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine</brief_title>
  <official_title>A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg&#xD;
      daily for the prevention of migraine in Japanese participants with chronic or episodic&#xD;
      migraine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Anticipated">June 14, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 14, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants with at Least 1 Treatment Emergent Adverse Event</measure>
    <time_frame>Across the 52-week treatment period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator</measure>
    <time_frame>Across the 52-week treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator</measure>
    <time_frame>Across the 52-week treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator</measure>
    <time_frame>Across the 52-week treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales</measure>
    <time_frame>Across the 52-week treatment period</time_frame>
    <description>A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Chronic Migraine</condition>
  <condition>Episodic Migraine</condition>
  <arm_group>
    <arm_group_label>Atogepant 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Taken once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atogepant 60 mg</intervention_name>
    <description>Tablets containing 60 mg atogepant</description>
    <arm_group_label>Atogepant 60 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        3101-303-002 Completers:&#xD;
&#xD;
          -  Eligible participants who completed Visit 7, and Visit 8 if applicable, of the Study&#xD;
             3101-303-002 without significant protocol deviations and who did not experience an&#xD;
             adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable&#xD;
             safety risk.&#xD;
&#xD;
        De Novo EM Participants:&#xD;
&#xD;
          -  Age of the participant at the time of migraine onset &lt; 50 years.&#xD;
&#xD;
          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis&#xD;
             according to the ICHD-3, 2018.&#xD;
&#xD;
          -  History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1&#xD;
             in the investigator's judgment.&#xD;
&#xD;
          -  4 to 14 migraine days in the 28-day baseline period per eDiary.&#xD;
&#xD;
          -  Completed at least 20 out of 28 days in the eDiary during baseline period and is able&#xD;
             to read, understand, and complete the study questionnaires and eDiary per&#xD;
             investigator's judgment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requirement for any medication, diet, or nonpharmacological treatment that is on the&#xD;
             list of prohibited concomitant medications or treatments that cannot be discontinued&#xD;
             or switched to an allowable alternative medication or treatment.&#xD;
&#xD;
          -  Participants with an ECG indicating clinically significant abnormalities at Visit -1&#xD;
             (De Novo Episodic Migraine Participants) or Visit 1 (3103-303-002 Completers).&#xD;
&#xD;
          -  Hypertension as defined by sitting systolic BP &gt; 160 mm Hg or sitting diastolic BP &gt;&#xD;
             100 mm Hg at Visit 1.&#xD;
&#xD;
          -  Significant risk of self-harm based on clinical interview and responses on the&#xD;
             (Columbia-Suicide Severity Rating Scale [C-SSRS]), or of harm to others in the opinion&#xD;
             of the investigator.&#xD;
&#xD;
          -  Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal,&#xD;
             hepatic, gastrointestinal, or neurologic disease.&#xD;
&#xD;
        De Novo EM Participants only:&#xD;
&#xD;
          -  Difficulty distinguishing migraine headaches from tension-type or other headaches.&#xD;
&#xD;
          -  Has a history of migraine accompanied by diplopia or decreased level of consciousness&#xD;
             or retinal migraine as defined by ICHD-3, 2018.&#xD;
&#xD;
          -  Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal&#xD;
             autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined&#xD;
             by ICHD-3, 2018.&#xD;
&#xD;
          -  Has &gt;= 15 headache days per month on average across the 3 months prior to Visit 1 in&#xD;
             the investigator's judgment.&#xD;
&#xD;
          -  Has &gt;= 15 headache days in the 28-day baseline period per eDiary.&#xD;
&#xD;
          -  Usage of opioids or barbiturates &gt; 2 days/month, triptans or ergots &gt;= 10 days/month,&#xD;
             or simple analgesics &gt;= 15 days/month in the 3 months prior to Visit 1 per&#xD;
             investigator's judgment or during the baseline period.&#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>ALLERGAN INC.</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Takanoko Hospital /ID# 232723</name>
      <address>
        <city>Matsuyama-shi</city>
        <state>Ehime</state>
        <zip>790-0925</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuiken Saiseikai Hospital /ID# 232988</name>
      <address>
        <city>Fukui-shi</city>
        <state>Fukui</state>
        <zip>918-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>003-0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konan Medical Center /ID# 232922</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>658-0064</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mito Kyodo General Hospital /ID# 232990</name>
      <address>
        <city>Mito-shi</city>
        <state>Ibaraki</state>
        <zip>310-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atsuchi Neurosurgical Hospital /ID# 232907</name>
      <address>
        <city>Kagoshima-shi</city>
        <state>Kagoshima</state>
        <zip>892-0842</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital /ID# 233071</name>
      <address>
        <city>Isehara-shi</city>
        <state>Kanagawa</state>
        <zip>259-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujitsu Clinic /ID# 232717</name>
      <address>
        <city>Kawasaki-shi</city>
        <state>Kanagawa</state>
        <zip>211-8588</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umenotsuji Clinic /ID# 232675</name>
      <address>
        <city>Kochi-shi</city>
        <state>Kochi</state>
        <zip>780-8011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>982-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University Hospital /ID# 233017</name>
      <address>
        <city>Iruma-gun</city>
        <state>Saitama</state>
        <zip>350-0495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Neuropsychiatric Institute /Id# 232711</name>
      <address>
        <city>Saitama-shi</city>
        <state>Saitama</state>
        <zip>338-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Shizuoka Hospital /ID# 232992</name>
      <address>
        <city>Shizuoka-shi</city>
        <state>Shizuoka</state>
        <zip>420-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Hospital /ID# 232995</name>
      <address>
        <city>Shimotsuga-gun</city>
        <state>Tochigi</state>
        <zip>321-0293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niwa Family Clinic /ID# 232713</name>
      <address>
        <city>Chofu-shi</city>
        <state>Tokyo</state>
        <zip>182-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Headache Clinic /ID# 232715</name>
      <address>
        <city>Shibuya-ku</city>
        <state>Tokyo</state>
        <zip>151-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital /ID# 233030</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagaseki Headache Clinic /ID# 232719</name>
      <address>
        <city>Kai-shi</city>
        <state>Yamanashi</state>
        <zip>400-0124</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DOI Internal Medicine-Neurology Clinic /ID# 232722</name>
      <address>
        <city>Hiroshima</city>
        <zip>730-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima Neurology Clinic /ID# 232720</name>
      <address>
        <city>Hiroshima</city>
        <zip>732-0822</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tanaka Neurosurgical clinic /ID# 232884</name>
      <address>
        <city>Kagoshima</city>
        <zip>892-0844</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tatsuoka Neurology Clinic /ID# 232912</name>
      <address>
        <city>Kyoto</city>
        <zip>600-8811</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tominaga Hospital /ID# 232909</name>
      <address>
        <city>Osaka</city>
        <zip>556-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinagawa Strings Clinic /ID# 232908</name>
      <address>
        <city>Tokyo</city>
        <zip>108-0075</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.abbvieclinicaltrials.com/study/?id=3101-306-002</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Migraine</keyword>
  <keyword>Episodic Migraine</keyword>
  <keyword>Atogepant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04437433
org study id: 3101-306-002
nct id: NCT04437433
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg
      daily for the prevention of migraine in Japanese participants with chronic or episodic
      migraine.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
time frame: Across the 52-week treatment period
measure: Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
time frame: Across the 52-week treatment period
measure: Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
time frame: Across the 52-week treatment period
measure: Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
time frame: Across the 52-week treatment period
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
time frame: Across the 52-week treatment period
description: A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)
arm group label: Atogepant 60 mg
arm group type: Experimental
description: Taken once daily
intervention type: Drug
intervention name: Atogepant 60 mg
description: Tablets containing 60 mg atogepant
arm group label: Atogepant 60 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: ALLERGAN INC.
role: Study Director
affiliation: Allergan
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country: Japan
url: https://www.abbvieclinicaltrials.com/study/?id=3101-306-002
description: Related Info
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/