<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/NCT01662492</url>
  </required_header>
  <id_info>
    <org_study_id>191622-103</org_study_id>
    <nct_id>NCT01662492</nct_id>
  </id_info>
  <brief_title>A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine</brief_title>
  <official_title>191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to &lt; 18 Years of Age) With Chronic Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline)&#xD;
      as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the Frequency of Headache Days</measure>
    <time_frame>Baseline, 12 Weeks</time_frame>
    <description>Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Frequency of Severe Headache Days</measure>
    <time_frame>Baseline, 12 Weeks</time_frame>
    <description>Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Total Cumulative Hours of Headache on Headache Days</measure>
    <time_frame>Baseline, 12 Weeks</time_frame>
    <description>Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days</measure>
    <time_frame>Baseline, 12 Weeks</time_frame>
    <description>Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Migraine Disorders</condition>
  <arm_group>
    <arm_group_label>Botulinum toxin type A Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum toxin type A Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Normal Saline)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Botulinum toxin type A Dose 1</intervention_name>
    <description>Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.</description>
    <arm_group_label>Botulinum toxin type A Dose 1</arm_group_label>
    <other_name>onabotulinumtoxinA</other_name>
    <other_name>BOTOX®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Botulinum toxin type A Dose 2</intervention_name>
    <description>Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.</description>
    <arm_group_label>Botulinum toxin type A Dose 2</arm_group_label>
    <other_name>onabotulinumtoxinA</other_name>
    <other_name>BOTOX®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (Normal Saline)</intervention_name>
    <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
    <arm_group_label>Placebo (Normal Saline)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical history of chronic migraine for at least 6 months&#xD;
&#xD;
          -  15 or more headache days during a 4 week period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous use of any botulinum toxin of any serotype for any reason&#xD;
&#xD;
          -  Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis&#xD;
&#xD;
          -  Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS),&#xD;
             cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks&#xD;
             prior to the week -4 screening visit&#xD;
&#xD;
          -  Use of any headache prophylaxis medication within 4 weeks prior to the week -4&#xD;
             screening visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Children's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fullerton Neurology and Headache Center</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Research Center of Southern California</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco Clinical Research Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Hospital and Clinics</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Neurologists of Southern CT, P.C.</name>
      <address>
        <city>Fairfield</city>
        <state>Connecticut</state>
        <zip>06824</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Institute for Clinical Research</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NW FL Clinical Research Group, LLC</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Neurology, PA</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Premiere Research Institute at Palm Beach Neurology</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Josephson Wallack Munshower Neurology, P.C.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPFCC Neurology Research Department</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Head Pain &amp; Neurological Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CORE (Center for Outpatient Research)</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renown Institution for Neurosciences</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Clinical Research, Inc</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Health Science Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jill Waldo, CCRC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nashville Neuroscience Group</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Association of Pediatric Neurology/Road Runner Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wasatch Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.allerganclinicaltrials.com</url>
    <description>More Information</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>August 3, 2017</results_first_submitted>
  <results_first_submitted_qc>August 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 5, 2017</results_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Botulinum Toxin Type A 155 U</title>
          <description>Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.</description>
        </group>
        <group group_id="P2">
          <title>Botulinum Toxin Type A 74 U</title>
          <description>Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.</description>
        </group>
        <group group_id="P3">
          <title>Placebo (Normal Saline)</title>
          <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other miscellaneous reasons.</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Botulinum Toxin Type A 155 U</title>
          <description>Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.</description>
        </group>
        <group group_id="B2">
          <title>Botulinum Toxin Type A 74 U</title>
          <description>Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.</description>
        </group>
        <group group_id="B3">
          <title>Placebo (Normal Saline)</title>
          <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
            <count group_id="B2" value="43"/>
            <count group_id="B3" value="37"/>
            <count group_id="B4" value="125"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.1" spread="1.4"/>
                    <measurement group_id="B2" value="15.0" spread="1.5"/>
                    <measurement group_id="B3" value="15.2" spread="1.5"/>
                    <measurement group_id="B4" value="15.1" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Frequency of Headache Days</title>
        <description>Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.</description>
        <time_frame>Baseline, 12 Weeks</time_frame>
        <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A 155 U</title>
            <description>Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O2">
            <title>Botulinum Toxin Type A 74 U</title>
            <description>Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Normal Saline)</title>
            <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Frequency of Headache Days</title>
          <description>Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.</description>
          <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
          <units>Headache days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" spread="4.4"/>
                    <measurement group_id="O2" value="23.4" spread="4.8"/>
                    <measurement group_id="O3" value="25.3" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" spread="7.0"/>
                    <measurement group_id="O2" value="-6.4" spread="7.8"/>
                    <measurement group_id="O3" value="-6.8" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Frequency of Severe Headache Days</title>
        <description>Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.</description>
        <time_frame>Baseline, 12 Weeks</time_frame>
        <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A 155 U</title>
            <description>Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O2">
            <title>Botulinum Toxin Type A 74 U</title>
            <description>Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Normal Saline)</title>
            <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Frequency of Severe Headache Days</title>
          <description>Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.</description>
          <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
          <units>Severe Headache Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="5.0"/>
                    <measurement group_id="O2" value="7.8" spread="6.2"/>
                    <measurement group_id="O3" value="9.1" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="4.7"/>
                    <measurement group_id="O2" value="-2.3" spread="6.3"/>
                    <measurement group_id="O3" value="-0.9" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Total Cumulative Hours of Headache on Headache Days</title>
        <description>Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.</description>
        <time_frame>Baseline, 12 Weeks</time_frame>
        <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A 155 U</title>
            <description>Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O2">
            <title>Botulinum Toxin Type A 74 U</title>
            <description>Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Normal Saline)</title>
            <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Total Cumulative Hours of Headache on Headache Days</title>
          <description>Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.</description>
          <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
          <units>Cumulative hours of headache</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170.69" spread="151.60"/>
                    <measurement group_id="O2" value="175.98" spread="139.76"/>
                    <measurement group_id="O3" value="212.68" spread="184.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.52" spread="53.19"/>
                    <measurement group_id="O2" value="-19.03" spread="113.73"/>
                    <measurement group_id="O3" value="-50.04" spread="87.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days</title>
        <description>Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.</description>
        <time_frame>Baseline, 12 Weeks</time_frame>
        <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A 155 U</title>
            <description>Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O2">
            <title>Botulinum Toxin Type A 74 U</title>
            <description>Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Normal Saline)</title>
            <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days</title>
          <description>Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.</description>
          <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9"/>
                    <measurement group_id="O2" value="32.6"/>
                    <measurement group_id="O3" value="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment</title>
        <description>Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.</description>
        <time_frame>12 Weeks</time_frame>
        <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Botulinum Toxin Type A 155 U</title>
            <description>Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O2">
            <title>Botulinum Toxin Type A 74 U</title>
            <description>Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Normal Saline)</title>
            <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment</title>
          <description>Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.</description>
          <population>Intent-to-Treat (ITT) Population: All randomized subjects.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4"/>
                    <measurement group_id="O2" value="9.3"/>
                    <measurement group_id="O3" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 12</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Botulinum Toxin Type A 155 U</title>
          <description>Botulinum toxin type A, 155 U, intramuscular injections into specified muscles.</description>
        </group>
        <group group_id="E2">
          <title>Botulinum Toxin Type A 74 U</title>
          <description>Botulinum toxin type A, 74 U, intramuscular injections into specified muscles.</description>
        </group>
        <group group_id="E3">
          <title>Placebo (Normal Saline)</title>
          <description>Placebo (Normal Saline) intramuscular injections into specified muscles.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA, version 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA, version 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>Allergan, Inc</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01662492
org study id: 191622-103
nct id: NCT01662492
lead sponsor: 
has dmc: Yes
To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline)
      as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change From Baseline in the Frequency of Headache Days
time frame: Baseline, 12 Weeks
description: Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.
measure: Change From Baseline in the Frequency of Severe Headache Days
time frame: Baseline, 12 Weeks
description: Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.
measure: Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
time frame: Baseline, 12 Weeks
description: Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.
measure: Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days
time frame: Baseline, 12 Weeks
description: Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.
measure: Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
time frame: 12 Weeks
description: Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.
arm group label: Botulinum toxin type A Dose 1
arm group type: Experimental
description: Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
arm group label: Botulinum toxin type A Dose 2
arm group type: Experimental
description: Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
arm group label: Placebo (Normal Saline)
arm group type: Placebo Comparator
description: Placebo (Normal Saline) intramuscular injections into specified muscles.
intervention type: Biological
intervention name: Botulinum toxin type A Dose 1
description: Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
arm group label: Botulinum toxin type A Dose 1
other name: onabotulinumtoxinA
other name: BOTOX®
intervention type: Biological
intervention name: Botulinum toxin type A Dose 2
description: Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
arm group label: Botulinum toxin type A Dose 2
other name: onabotulinumtoxinA
other name: BOTOX®
intervention type: Drug
intervention name: Placebo (Normal Saline)
description: Placebo (Normal Saline) intramuscular injections into specified muscles.
arm group label: Placebo (Normal Saline)
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
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country: United States
url: http://www.allerganclinicaltrials.com
description: More Information
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 