<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/NCT03832998</url>
  </required_header>
  <id_info>
    <org_study_id>20160354</org_study_id>
    <secondary_id>2017-002399-23</secondary_id>
    <nct_id>NCT03832998</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine</brief_title>
  <acronym>OASIS(CM)</acronym>
  <official_title>A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to &lt; 12 Years) and Adolescents (12 to &lt; 18 Years) With Chronic Migraine (OASIS PEDIATRIC [CM])</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Amgen</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>
      This study will evaluate the efficacy and safety of erenumab in migraine prevention in&#xD;
      children (6 to &lt;12 years) and adolescents (12 to &lt;18 years) with chronic migraine. The study&#xD;
      hypothesis is that in pediatric subjects with chronic migraine, the combined erenumab dose&#xD;
      group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly&#xD;
      migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study&#xD;
      to evaluate the efficacy and safety of Erenumab in migraine prevention in children (6 to &lt;12&#xD;
      years) and adolescents (12 to &lt;18 years) with chronic migraine.&#xD;
&#xD;
      The trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week&#xD;
      prospective baseline phase); the double-blind treatment phase (24 weeks) in which&#xD;
      participants receive placebo or Erenumab dose 1, dose 2 or dose 3 (based on participant's&#xD;
      body weight) via subcutaneous injection once a month; the optional dose level blinded&#xD;
      extension phase (40 weeks), in which all participants are assigned to receive dose 1, dose 2&#xD;
      or dose 3 of Erenumab; and a 12 weeks safety follow-up phase (16 weeks after the last dose of&#xD;
      investigational drug).&#xD;
&#xD;
      The study intends to enroll 286 participants (256 adolescents and 30 children).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 5, 2019</start_date>
  <completion_date type="Anticipated">June 28, 2027</completion_date>
  <primary_completion_date type="Anticipated">June 29, 2026</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in monthly migraine days (MMDs)</measure>
    <time_frame>Baseline through week 12 of the double blind treatment phase</time_frame>
    <description>To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in monthly headache days from baseline</measure>
    <time_frame>Baseline through week 12 of the double blind treatment phase</time_frame>
    <description>To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly headache days to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with at least 50% reduction in monthly migraine days (MMDs) from baseline</measure>
    <time_frame>Baseline through week 12 of the double blind treatment phase</time_frame>
    <description>To evaluate the effect of erenumab compared with placebo on the proportion of subjects with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in monthly migraine days (MMDs) from baseline to the average of the first 3 months</measure>
    <time_frame>Baseline through week 12 of the double blind treatment phase</time_frame>
    <description>To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the first 3 months (week 1 through week 12) of the double-blind treatment period (DBTP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in monthly migraine days (MMDs) from baseline to the average of the first 6 months</measure>
    <time_frame>Completion of double blind treatment phase at 24 weeks</time_frame>
    <description>To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the 6 month (week 1 through week 24) double-blind treatment period (DBTP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)</measure>
    <time_frame>Baseline through week 12 of the double blind treatment phase</time_frame>
    <description>To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP). This will be measured in an electronic diary (eDiary) with a visual analogue scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in migraine-related disability and productivity</measure>
    <time_frame>Baseline through week 12 of the double blind treatment phase</time_frame>
    <description>To evaluate the effect of erenumab compared with placebo on the change from baseline in migraine-related disability and productivity as measured by the modified Pediatric Migraine Disability Assessment Questionnaire (modified PedMIDAS) to month 3 of the double-blind treatment period (DBTP).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">286</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Dose Level 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to one of two doses determined by their body weight at Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Level 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to one of two doses determined by their body weight at Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erenumab Dose 1</intervention_name>
    <description>Subjects in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.</description>
    <arm_group_label>Dose Level 1</arm_group_label>
    <other_name>AMG 334</other_name>
    <other_name>Aimovig®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erenumab Dose 2</intervention_name>
    <description>Subjects in the low body-weight group at day 1 who are randomized to Dose Level 2 and subjects in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.</description>
    <arm_group_label>Dose Level 1</arm_group_label>
    <arm_group_label>Dose Level 2</arm_group_label>
    <other_name>AMG 334</other_name>
    <other_name>Aimovig®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erenumab Dose 3</intervention_name>
    <description>Subjects in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.</description>
    <arm_group_label>Dose Level 2</arm_group_label>
    <other_name>AMG 334</other_name>
    <other_name>Aimovig®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching dose for erenumab dose 1, 2 and 3.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of&#xD;
             age) at the time of signing, if developmentally appropriate, the formal assent to&#xD;
             participate to the study.&#xD;
&#xD;
          -  Subject's parent or legal representative has provided written informed consent before&#xD;
             initiation of any study-specific activities/procedures.&#xD;
&#xD;
          -  History of migraine (with or without aura) for ≥ 12 months before screening according&#xD;
             to the IHS Classification ICHD-3 (Headache Classification Committee of the&#xD;
             International Headache Society, 2013) ICHD-3 specifications for pediatric migraine&#xD;
             (subjects aged less than 18 years), should be considered for the diagnosis of&#xD;
             migraine.&#xD;
&#xD;
          -  History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by&#xD;
             the subject as migraine days per month in each of the 3 months prior to screening.&#xD;
&#xD;
          -  Migraine frequency: greater than or equal to 8 migraine days based on the eDiary data&#xD;
             during the last 28 days of the baseline phase if more than 28 days in duration.&#xD;
&#xD;
          -  Headache frequency of greater than or equal to 15 headache days based on the eDiary&#xD;
             data during the last 28 days of the baseline phase if more than 28 days in duration.&#xD;
&#xD;
          -  Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the&#xD;
             baseline period, if more than 28 days in duration (eg, completing eDiary items for at&#xD;
             least 23 out of the last 28 days of the baseline phase).&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History of cluster headache or hemiplegic migraine headache.&#xD;
&#xD;
          -  Chronic migraine with continuous pain, in which the subject does not have any pain&#xD;
             free periods (of any duration) during the 1 month prior to screening.&#xD;
&#xD;
          -  No therapeutic response with greater than 3 medication categories for prophylactic&#xD;
             treatment of migraine after an adequate therapeutic trial. No therapeutic response is&#xD;
             defined as no reduction in headache frequency, duration, or severity after&#xD;
             administration of the medication for at least 6 weeks at the generally-accepted&#xD;
             therapeutic dose(s) based on the investigator's assessment.&#xD;
&#xD;
          -  History of suicidal behavior or the subject is at risk of self-harm or harm to others.&#xD;
&#xD;
          -  History of major psychiatric disorder. Subjects with anxiety disorder and/or mild&#xD;
             major depressive disorder (Patient Health Questionnaire Modified for Adolescents&#xD;
             [PHQ-A] score 9) are permitted in the study if they are considered by the investigator&#xD;
             to be stable and are taking no more than 1 medication for each disorder. Subjects must&#xD;
             have been on a stable dose within the 3 months before the start of the baseline phase.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amgen Call Center</last_name>
    <phone>866-572-6436</phone>
    <email>medinfo@amgen.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Childrens Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Terminated</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Childrens National Health System</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>TrueBlue Clinical Research</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwest Florida Clinical Research Group Limited Liability Company</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nicklaus Childrens Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>CenExel iResearch, LLC</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ann and Robert H Lurie Childrens Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Josephson Wallack Munshower Neurology</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Maryland, Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>New England Regional Headache Center Inc</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Michigan Head Pain and Neurological Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute Inc</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <zip>55441</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Childrens Mercy Hospital and Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mercy Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research LLC</name>
      <address>
        <city>Hastings</city>
        <state>Nebraska</state>
        <zip>68901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dent Neurosciences Research Center</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cincinnati Childrens Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Nationwide Childrens Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Preferred Primary Care Physicians, Inc</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15236</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Palmetto Gastroenterology Clinical Research, LLC</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29486</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Childrens Specialty Group</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vaught Neurological Services</name>
      <address>
        <city>Crab Orchard</city>
        <state>West Virginia</state>
        <zip>25827</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Docteur Simona Sava srl</name>
      <address>
        <city>Saint Nicolas</city>
        <zip>4420</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stollery Childrens Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1C9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital of Eastern Ontario</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Hospital For Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundacion Centro de Investigacion Clinica</name>
      <address>
        <city>Medellín</city>
        <state>Antioquia</state>
        <zip>050021</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Solano y Terront Servicios Medicos Ltda - Unidad Integral de Endocrinologia Uniendo</name>
      <address>
        <city>Bogota</city>
        <state>Cundinamarca</state>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cafam</name>
      <address>
        <city>Bogota</city>
        <state>Cundinamarca</state>
        <zip>111211</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Fundacion Hospital Infantil Universitario De San Jose</name>
      <address>
        <city>Bogota</city>
        <state>Cundinamarca</state>
        <zip>111221</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundacion Cardiovascular de Colombia</name>
      <address>
        <city>Bucaramanga</city>
        <state>Santander</state>
        <zip>681017</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Terveystalo Pulssi</name>
      <address>
        <city>Turku</city>
        <zip>20100</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Charite - Universitaetsmedizin Berlin, Campus Virchow</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Schmerzklinik Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24149</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Arzneimittelforschung Leipzig GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04107</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dr Kenessey Albert Korhaz - Rendelointezet</name>
      <address>
        <city>Balassagyarmat</city>
        <zip>2660</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Dr Altmann Anna egyeni vallalkozo</name>
      <address>
        <city>Budapest</city>
        <zip>1026</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>High Tech Medical Kft</name>
      <address>
        <city>Budapest</city>
        <zip>1064</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz</name>
      <address>
        <city>Miskolc</city>
        <zip>3526</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Neurologico Carlo Besta</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda ospedaliera di rilievo nazionale e di alta specializzazione Civico di Cristina Benfratelli</name>
      <address>
        <city>Palermo</city>
        <zip>90134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fondazione Istituto Neurologico Nazionale C Mondino IRCCS</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Pediatrico Bambino Gesu</name>
      <address>
        <city>Roma</city>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Josai Kids Clinic</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>451-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hiroshima City Hiroshima Citizens Hospital</name>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima</state>
        <zip>730-8518</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Kitami Clinic</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>060-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Konan Medical Center</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>658-0064</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kumamoto City Hospital</name>
      <address>
        <city>Kumamoto-shi</city>
        <state>Kumamoto</state>
        <zip>862-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tatsuoka Neurology Clinic</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>600-8811</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Kyoto Daiichi Hospital</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>605-0981</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sendai Headache and Neurology Clinic</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>982-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tominaga Hospital</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>556-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saitama Neuropsychiatric Institute</name>
      <address>
        <city>Saitama-shi</city>
        <state>Saitama</state>
        <zip>338-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Headache Clinic</name>
      <address>
        <city>Shibuya-ku</city>
        <state>Tokyo</state>
        <zip>151-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagamitsu Clinic</name>
      <address>
        <city>Hofu-shi</city>
        <state>Yamaguchi</state>
        <zip>747-0802</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagaseki Headache Clinic</name>
      <address>
        <city>Kai-shi</city>
        <state>Yamanashi</state>
        <zip>400-0124</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Instytut Centrum Zdrowia Matki Polki</name>
      <address>
        <city>Lodz</city>
        <zip>93-338</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Luxmed Spzoo</name>
      <address>
        <city>Lublin</city>
        <zip>20-109</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Hope Clinic Sebastian Szklener</name>
      <address>
        <city>Lublin</city>
        <zip>20-701</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny w Poznaniu</name>
      <address>
        <city>Poznan</city>
        <zip>60-355</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center Spzoo Medic-R Spolka Komandytowa</name>
      <address>
        <city>Poznan</city>
        <zip>61-731</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dr Sekowska Leczenie Bolu</name>
      <address>
        <city>Warszawa</city>
        <zip>01-018</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Next Stage Spzoo</name>
      <address>
        <city>Warszawa</city>
        <zip>02-121</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak</name>
      <address>
        <city>Wroclaw</city>
        <zip>52-210</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Puerto Rico Health Institute</name>
      <address>
        <city>Dorado</city>
        <zip>00646</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FSBI Russian Children Clinical Hospital of the MoH RF</name>
      <address>
        <city>Moscow</city>
        <zip>119571</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>LLC clinic Chaika</name>
      <address>
        <city>Moscow</city>
        <zip>125047</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>LLC Sibneyromed</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630004</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>LLC Medical Technologies</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191025</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Noahs Ark Childrens Hospital for Wales</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Hospital for Children</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alder Hey Childrens Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>L12 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Evelina Childrens Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital for Children</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oxford Childrens Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migraine</keyword>
  <keyword>Headache</keyword>
  <keyword>Prevention</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Chronic Migraine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erenumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>https://www.amgen.com/datasharing</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/NCT03832998
org study id: 20160354
secondary id: 2017-002399-23
nct id: NCT03832998
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the efficacy and safety of erenumab in migraine prevention in
      children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study
      hypothesis is that in pediatric subjects with chronic migraine, the combined erenumab dose
      group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly
      migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).
This study is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study
      to evaluate the efficacy and safety of Erenumab in migraine prevention in children (6 to <12
      years) and adolescents (12 to <18 years) with chronic migraine.

      The trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week
      prospective baseline phase); the double-blind treatment phase (24 weeks) in which
      participants receive placebo or Erenumab dose 1, dose 2 or dose 3 (based on participant's
      body weight) via subcutaneous injection once a month; the optional dose level blinded
      extension phase (40 weeks), in which all participants are assigned to receive dose 1, dose 2
      or dose 3 of Erenumab; and a 12 weeks safety follow-up phase (16 weeks after the last dose of
      investigational drug).

      The study intends to enroll 286 participants (256 adolescents and 30 children).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in monthly migraine days (MMDs)
time frame: Baseline through week 12 of the double blind treatment phase
description: To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP).
measure: Change in monthly headache days from baseline
time frame: Baseline through week 12 of the double blind treatment phase
description: To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly headache days to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP)
measure: Proportion of subjects with at least 50% reduction in monthly migraine days (MMDs) from baseline
time frame: Baseline through week 12 of the double blind treatment phase
description: To evaluate the effect of erenumab compared with placebo on the proportion of subjects with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP)
measure: Change in monthly migraine days (MMDs) from baseline to the average of the first 3 months
time frame: Baseline through week 12 of the double blind treatment phase
description: To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the first 3 months (week 1 through week 12) of the double-blind treatment period (DBTP).
measure: Change in monthly migraine days (MMDs) from baseline to the average of the first 6 months
time frame: Completion of double blind treatment phase at 24 weeks
description: To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the 6 month (week 1 through week 24) double-blind treatment period (DBTP).
measure: Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
time frame: Baseline through week 12 of the double blind treatment phase
description: To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP). This will be measured in an electronic diary (eDiary) with a visual analogue scale.
measure: Change from baseline in migraine-related disability and productivity
time frame: Baseline through week 12 of the double blind treatment phase
description: To evaluate the effect of erenumab compared with placebo on the change from baseline in migraine-related disability and productivity as measured by the modified Pediatric Migraine Disability Assessment Questionnaire (modified PedMIDAS) to month 3 of the double-blind treatment period (DBTP).
arm group label: Dose Level 1
arm group type: Experimental
description: Subjects will be randomized to one of two doses determined by their body weight at Day 1.
arm group label: Dose Level 2
arm group type: Experimental
description: Subjects will be randomized to one of two doses determined by their body weight at Day 1.
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Erenumab Dose 1
description: Subjects in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
arm group label: Dose Level 1
other name: AMG 334
other name: Aimovig®
intervention type: Drug
intervention name: Erenumab Dose 2
description: Subjects in the low body-weight group at day 1 who are randomized to Dose Level 2 and subjects in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
arm group label: Dose Level 1
arm group label: Dose Level 2
other name: AMG 334
other name: Aimovig®
intervention type: Drug
intervention name: Erenumab Dose 3
description: Subjects in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
arm group label: Dose Level 2
other name: AMG 334
other name: Aimovig®
intervention type: Other
intervention name: Placebo
description: Placebo matching dose for erenumab dose 1, 2 and 3.
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
last name: Amgen Call Center
phone: 866-572-6436
email: medinfo@amgen.com
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
country: Belgium
country: Canada
country: Colombia
country: Finland
country: Germany
country: Hungary
country: Italy
country: Japan
country: Poland
country: Puerto Rico
country: Russian Federation
country: United Kingdom
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Erenumab
mesh term: Antibodies, Monoclonal
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: https://www.amgen.com/datasharing