<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/NCT04458857</url>
  </required_header>
  <id_info>
    <org_study_id>TV48125-CNS-30083</org_study_id>
    <secondary_id>2019-002055-42</secondary_id>
    <nct_id>NCT04458857</nct_id>
  </id_info>
  <brief_title>A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teva Branded Pharmaceutical Products R&amp;D, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teva Branded Pharmaceutical Products R&amp;D, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to evaluate the effectiveness of fremanezumab as&#xD;
      compared to placebo for the preventive treatment of episodic migraine (EM).&#xD;
&#xD;
      Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to&#xD;
      placebo for the preventive treatment of EM, to evaluate the safety and tolerability of&#xD;
      Fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of&#xD;
      Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in&#xD;
      participants exposed to Fremanezumab.&#xD;
&#xD;
      The total duration of the study is planned to be up to 36 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">February 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</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>Mean change in the monthly average number of migraine days after the first dose of study drug</measure>
    <time_frame>Baseline - Month 3</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug</measure>
    <time_frame>Baseline - Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug</measure>
    <time_frame>Baseline - Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug</measure>
    <time_frame>Baseline - Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug</measure>
    <time_frame>Baseline and Month 3</time_frame>
    <description>The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four &quot;disability grades:&quot; 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and &gt;50 = severe disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change PedsQL after administration of the first dose of study drug</measure>
    <time_frame>Baseline - Month 3</time_frame>
    <description>Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows:&#xD;
0=never a problem;&#xD;
almost never a problem;&#xD;
sometimes a problem;&#xD;
often a problem;&#xD;
almost always a problem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Baseline - Month 3</time_frame>
    <description>including local injection site reaction/pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings</measure>
    <time_frame>Baseline - Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal vital signs</measure>
    <time_frame>Baseline - Month 3</time_frame>
    <description>(systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant changes in laboratory values</measure>
    <time_frame>Baseline, Month 1, and Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal physical examination findings</measure>
    <time_frame>Baseline - Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yes/No suicidality ideation</measure>
    <time_frame>Screening - Month 3</time_frame>
    <description>Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants developing antidrug antibodies (ADAs) throughout the study</measure>
    <time_frame>Baseline - Month 3</time_frame>
    <description>The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">288</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Fremanezumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants weighing ≥ threshold will receive Dose A subcutaneously monthly Participants weighing &lt; threshold will receive Dose B subcutaneously monthly subcutaneously monthly, for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fremanezumab</intervention_name>
    <description>Dose A or Dose B subcutaneous</description>
    <arm_group_label>Fremanezumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The participant has a clinical history of recurrent headache consistent with the&#xD;
             diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3&#xD;
             criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14&#xD;
             headache days per month in each of the 3 months prior to screening (visit 1).&#xD;
&#xD;
          -  The participant or parent/caregiver maintain a prospectively collected headache diary&#xD;
&#xD;
          -  The participant does not have chronic daily headache. For the purposes of this study,&#xD;
             chronic daily headache is operationally defined as &lt;4 headache-free days during the&#xD;
             28-day baseline period.&#xD;
&#xD;
        NOTE: Additional criteria apply; please contact the investigator for more information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participant is using medications containing opioids (including codeine) or&#xD;
             barbiturates (including Fiorinal®, Fioricet®, or any other combination containing&#xD;
             butalbital) for the treatment of migraine during the 3 months prior to the day of the&#xD;
             screening visit.&#xD;
&#xD;
          -  The participant or parent/caregiver maintain a prospectively collected headache diary&#xD;
&#xD;
          -  The participant has used an intervention/device (eg, scheduled nerve block or&#xD;
             transcranial magnetic stimulation) for the treatment of migraine or in the head or&#xD;
             neck area for any condition during the 2 months prior to the day of the screening&#xD;
             visit.&#xD;
&#xD;
          -  The participant has a current history of a clinically significant psychiatric&#xD;
             condition, any prior history of a suicide attempt, or a history of suicidal ideation&#xD;
             with a specific plan within the past 2 years, at the discretion of the investigator.&#xD;
&#xD;
          -  The participant has an ongoing infection or a known history of human immunodeficiency&#xD;
             virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known&#xD;
             active infection of coronavirus disease 2019 (COVID-19).&#xD;
&#xD;
          -  The participant has a past or current history of cancer.&#xD;
&#xD;
          -  The participant is pregnant or nursing.&#xD;
&#xD;
          -  The participant has a history of hypersensitivity reactions to injected proteins,&#xD;
             including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis&#xD;
             syndrome, or the participant is concomitantly using lamotrigine.&#xD;
&#xD;
          -  The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and&#xD;
             measles, mumps, and rubella vaccine) within the 12-week period prior to screening.&#xD;
             Note: If a medical need arises during the study, the participant may receive a live&#xD;
             attenuated vaccine.&#xD;
&#xD;
          -  The patient has a current or past medical history of hemiplegic migraine.&#xD;
&#xD;
        NOTE: Additional criteria apply; please contact the investigator for more information.&#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>Teva Medical Expert, MD</last_name>
    <role>Study Director</role>
    <affiliation>Teva Branded Pharmaceutical Products R&amp;D, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Teva U.S. Medical Information</last_name>
    <phone>1-888-483-8279</phone>
    <email>USMedInfo@tevapharm.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Teva Investigational Site 14281</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14253</name>
      <address>
        <city>Banning</city>
        <state>California</state>
        <zip>92220</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14370</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14322</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14277</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14361</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14319</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14368</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14244</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14325</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14250</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14255</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14243</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14258</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14263</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14283</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14245</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14327</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202-3800</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14360</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14365</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14317</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20910</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14246</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02451</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14251</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>Teva Investigational Site 14270</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14376</name>
      <address>
        <city>Ridgeland</city>
        <state>Mississippi</state>
        <zip>39157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14256</name>
      <address>
        <city>Bridgeton</city>
        <state>Missouri</state>
        <zip>63044</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14371</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14276</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14377</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14248</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14264</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229-3039</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14257</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14275</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73116</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14363</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14364</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-4318</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14374</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14252</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14273</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14367</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14274</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14312</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77087</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14366</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14241</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14375</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 14323</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 11180</name>
      <address>
        <city>Ajax</city>
        <state>Ontario</state>
        <zip>L1Z 0M1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 11179</name>
      <address>
        <city>Nepean</city>
        <state>Ontario</state>
        <zip>K2G 1W2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 11182</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>KIH 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 11181</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 40053</name>
      <address>
        <city>Helsinki</city>
        <zip>00380</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 40049</name>
      <address>
        <city>Kuopio</city>
        <zip>70210</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 40054</name>
      <address>
        <city>Oulu</city>
        <zip>90220</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 40052</name>
      <address>
        <city>Tampere</city>
        <zip>33521</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32728</name>
      <address>
        <city>Bad Homburg</city>
        <zip>61348</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32729</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32725</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32724</name>
      <address>
        <city>Essen</city>
        <zip>45257</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32726</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80166</name>
      <address>
        <city>Haifa</city>
        <zip>3339419</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80168</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80169</name>
      <address>
        <city>Jerusalem</city>
        <zip>9124001</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80167</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80164</name>
      <address>
        <city>Safed</city>
        <zip>13100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80165</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80170</name>
      <address>
        <city>Zerifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30230</name>
      <address>
        <city>Firenze</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30239</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30226</name>
      <address>
        <city>Milano</city>
        <zip>20154</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30228</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30238</name>
      <address>
        <city>Padua</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30227</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30225</name>
      <address>
        <city>Rome</city>
        <zip>00163</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 38138</name>
      <address>
        <city>Doetinchem</city>
        <zip>7009 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 38135</name>
      <address>
        <city>Nijmegen</city>
        <zip>6532 SZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 38136</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53441</name>
      <address>
        <city>Gdansk</city>
        <zip>80-389</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53437</name>
      <address>
        <city>Kielce</city>
        <zip>25-316</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53443</name>
      <address>
        <city>Krakow</city>
        <zip>30-363</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53452</name>
      <address>
        <city>Krakow</city>
        <zip>30-539</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53440</name>
      <address>
        <city>Lublin</city>
        <zip>21-003</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53439</name>
      <address>
        <city>Poznan</city>
        <zip>60-355</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53451</name>
      <address>
        <city>Poznan</city>
        <zip>60-848</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53442</name>
      <address>
        <city>Szczecin</city>
        <zip>70-111</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31271</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31266</name>
      <address>
        <city>Elda</city>
        <zip>03600</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31268</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31267</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31270</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31265</name>
      <address>
        <city>Valladolid</city>
        <zip>47010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>episodic migraine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request</ipd_description>
  </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/NCT04458857
org study id: TV48125-CNS-30083
secondary id: 2019-002055-42
nct id: NCT04458857
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to evaluate the effectiveness of fremanezumab as
      compared to placebo for the preventive treatment of episodic migraine (EM).

      Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to
      placebo for the preventive treatment of EM, to evaluate the safety and tolerability of
      Fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of
      Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in
      participants exposed to Fremanezumab.

      The total duration of the study is planned to be up to 36 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean change in the monthly average number of migraine days after the first dose of study drug
time frame: Baseline - Month 3
measure: Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug
time frame: Baseline - Month 3
measure: Number of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug
time frame: Baseline - Month 3
measure: Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug
time frame: Baseline - Month 3
measure: Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug
time frame: Baseline and Month 3
description: The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
measure: Mean change PedsQL after administration of the first dose of study drug
time frame: Baseline - Month 3
description: Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows:
0=never a problem;
almost never a problem;
sometimes a problem;
often a problem;
almost always a problem.
measure: Number of adverse events
time frame: Baseline - Month 3
description: including local injection site reaction/pain
measure: Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
time frame: Baseline - Month 3
measure: Incidence of abnormal vital signs
time frame: Baseline - Month 3
description: (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
measure: Number of participants with clinically significant changes in laboratory values
time frame: Baseline, Month 1, and Month 3
measure: Incidence of abnormal physical examination findings
time frame: Baseline - Month 3
measure: Yes/No suicidality ideation
time frame: Screening - Month 3
description: Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.
measure: Number of participants developing antidrug antibodies (ADAs) throughout the study
time frame: Baseline - Month 3
description: The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
arm group label: Fremanezumab
arm group type: Experimental
description: Participants weighing ≥ threshold will receive Dose A subcutaneously monthly Participants weighing < threshold will receive Dose B subcutaneously monthly subcutaneously monthly, for 3 months.
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo
intervention type: Drug
intervention name: Fremanezumab
description: Dose A or Dose B subcutaneous
arm group label: Fremanezumab
intervention type: Drug
intervention name: Placebo
description: Matching placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Teva Medical Expert, MD
role: Study Director
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
last name: Teva U.S. Medical Information
phone: 1-888-483-8279
email: USMedInfo@tevapharm.com
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
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: Completed
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: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Terminated
facility: 
status: Recruiting
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: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
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: 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: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
country: Canada
country: Finland
country: Germany
country: Israel
country: Italy
country: Netherlands
country: Poland
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request