<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/NCT02230956</url>
  </required_header>
  <id_info>
    <org_study_id>191622-145</org_study_id>
    <secondary_id>2014-001076-58</secondary_id>
    <nct_id>NCT02230956</nct_id>
  </id_info>
  <brief_title>BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis</brief_title>
  <official_title>BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of a single intra-articular injection of 2&#xD;
      doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee&#xD;
      osteoarthritis symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 2</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale</measure>
    <time_frame>Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24</time_frame>
    <description>The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale</measure>
    <time_frame>Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24</time_frame>
    <description>The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (GIC) Using a 7-Point Scale</measure>
    <time_frame>Weeks 1, 4, 8, 12, 16, 20 and 24</time_frame>
    <description>The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>OnabotulinumtoxinA 400 U</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OnabotulinumtoxinA 200 U</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>onabotulinumtoxinA</intervention_name>
    <description>onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.</description>
    <arm_group_label>OnabotulinumtoxinA 200 U</arm_group_label>
    <arm_group_label>OnabotulinumtoxinA 400 U</arm_group_label>
    <other_name>botulinum toxin Type A</other_name>
    <other_name>BOTOX®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Normal Saline (placebo) injection into the intra-articular space of the study knee.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Painful osteoarthritis&#xD;
&#xD;
          -  Able to discontinue anti-inflammatory drugs and analgesics&#xD;
&#xD;
          -  Must be ambulatory without assistive walking devices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain conditions other than knee osteoarthritis&#xD;
&#xD;
          -  Treatment with corticosteroids in the study knee within 12 weeks&#xD;
&#xD;
          -  Treatment with hyaluronic acid in the study knee within 24 weeks&#xD;
&#xD;
          -  Previous treatment with any botulinum toxin for any reason&#xD;
&#xD;
          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral&#xD;
             sclerosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 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>
      <address>
        <city>Artesia</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pardubice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vejle</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>http://www.allerganclinicaltrials.com</url>
    <description>More Information</description>
  </link>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <results_first_submitted>March 8, 2017</results_first_submitted>
  <results_first_submitted_qc>March 8, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 20, 2017</results_first_posted>
  <last_update_submitted>May 5, 2017</last_update_submitted>
  <last_update_submitted_qc>May 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 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>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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>OnabotulinumtoxinA 400 U</title>
          <description>OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>OnabotulinumtoxinA 200 U</title>
          <description>OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="82"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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>
              <title>Personal Reasons</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <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="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Miscellaneous Reason</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <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>OnabotulinumtoxinA 400 U</title>
          <description>OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>OnabotulinumtoxinA 200 U</title>
          <description>OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.</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="44"/>
            <count group_id="B2" value="43"/>
            <count group_id="B3" value="89"/>
            <count group_id="B4" value="176"/>
          </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="60.7" spread="8.25"/>
                    <measurement group_id="B2" value="60.2" spread="8.41"/>
                    <measurement group_id="B3" value="61.1" spread="7.79"/>
                    <measurement group_id="B4" value="60.8" spread="8.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale</title>
        <description>Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>OnabotulinumtoxinA 400 U</title>
            <description>OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>OnabotulinumtoxinA 200 U</title>
            <description>OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale</title>
          <description>Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.</description>
          <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.92" spread="1.222"/>
                    <measurement group_id="O2" value="6.09" spread="1.313"/>
                    <measurement group_id="O3" value="6.00" spread="1.150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.68" spread="1.641"/>
                    <measurement group_id="O2" value="-2.07" spread="1.602"/>
                    <measurement group_id="O3" value="-1.98" spread="1.793"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale</title>
        <description>The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24</time_frame>
        <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. &quot;n&quot; in the category is the number of participants with data available at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>OnabotulinumtoxinA 400 U</title>
            <description>OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>OnabotulinumtoxinA 200 U</title>
            <description>OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale</title>
          <description>The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.</description>
          <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. &quot;n&quot; in the category is the number of participants with data available at the given time-point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.84" spread="1.629"/>
                    <measurement group_id="O2" value="5.41" spread="1.806"/>
                    <measurement group_id="O3" value="5.34" spread="1.548"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.75" spread="1.567"/>
                    <measurement group_id="O2" value="-1.61" spread="1.666"/>
                    <measurement group_id="O3" value="-1.62" spread="1.805"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.82" spread="1.893"/>
                    <measurement group_id="O2" value="-1.67" spread="1.763"/>
                    <measurement group_id="O3" value="-1.81" spread="1.848"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="1.899"/>
                    <measurement group_id="O2" value="-1.52" spread="1.907"/>
                    <measurement group_id="O3" value="-1.76" spread="1.976"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.81" spread="1.975"/>
                    <measurement group_id="O2" value="-1.82" spread="1.870"/>
                    <measurement group_id="O3" value="-1.75" spread="2.014"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.67" spread="1.841"/>
                    <measurement group_id="O2" value="-1.64" spread="2.174"/>
                    <measurement group_id="O3" value="-1.62" spread="1.901"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.79" spread="1.937"/>
                    <measurement group_id="O2" value="-1.68" spread="2.066"/>
                    <measurement group_id="O3" value="-1.78" spread="2.037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.93" spread="2.289"/>
                    <measurement group_id="O2" value="-1.81" spread="2.181"/>
                    <measurement group_id="O3" value="-1.69" spread="2.008"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale</title>
        <description>The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24</time_frame>
        <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. &quot;n&quot; in the category is the number of participants with data available at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>OnabotulinumtoxinA 400 U</title>
            <description>OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>OnabotulinumtoxinA 200 U</title>
            <description>OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale</title>
          <description>The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.</description>
          <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. &quot;n&quot; in the category is the number of participants with data available at the given time-point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" spread="1.804"/>
                    <measurement group_id="O2" value="5.35" spread="1.995"/>
                    <measurement group_id="O3" value="4.99" spread="1.854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="1.424"/>
                    <measurement group_id="O2" value="-1.64" spread="1.870"/>
                    <measurement group_id="O3" value="-1.44" spread="1.933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.26" spread="1.672"/>
                    <measurement group_id="O2" value="-1.66" spread="1.908"/>
                    <measurement group_id="O3" value="-1.35" spread="2.069"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.54" spread="1.819"/>
                    <measurement group_id="O2" value="-1.50" spread="2.043"/>
                    <measurement group_id="O3" value="-1.27" spread="2.070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.30" spread="1.648"/>
                    <measurement group_id="O2" value="-1.68" spread="1.781"/>
                    <measurement group_id="O3" value="-1.40" spread="2.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.29" spread="1.558"/>
                    <measurement group_id="O2" value="-1.59" spread="2.127"/>
                    <measurement group_id="O3" value="-1.09" spread="1.991"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" spread="1.651"/>
                    <measurement group_id="O2" value="-1.44" spread="2.172"/>
                    <measurement group_id="O3" value="-1.18" spread="2.087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.48" spread="2.029"/>
                    <measurement group_id="O2" value="-1.56" spread="2.232"/>
                    <measurement group_id="O3" value="-1.12" spread="1.998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change (GIC) Using a 7-Point Scale</title>
        <description>The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.</description>
        <time_frame>Weeks 1, 4, 8, 12, 16, 20 and 24</time_frame>
        <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. &quot;n&quot; in the category is the number of participants with data available at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>OnabotulinumtoxinA 400 U</title>
            <description>OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>OnabotulinumtoxinA 200 U</title>
            <description>OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change (GIC) Using a 7-Point Scale</title>
          <description>The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.</description>
          <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. &quot;n&quot; in the category is the number of participants with data available at the given time-point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.00"/>
                    <measurement group_id="O2" value="1.2" spread="0.97"/>
                    <measurement group_id="O3" value="1.1" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="43"/>
                    <count group_id="O3" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.24"/>
                    <measurement group_id="O2" value="1.2" spread="1.23"/>
                    <measurement group_id="O3" value="1.2" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.09"/>
                    <measurement group_id="O2" value="0.9" spread="1.35"/>
                    <measurement group_id="O3" value="1.0" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.35"/>
                    <measurement group_id="O2" value="1.2" spread="1.30"/>
                    <measurement group_id="O3" value="1.0" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.31"/>
                    <measurement group_id="O2" value="1.1" spread="1.36"/>
                    <measurement group_id="O3" value="1.0" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.24"/>
                    <measurement group_id="O2" value="1.0" spread="1.42"/>
                    <measurement group_id="O3" value="1.0" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.34"/>
                    <measurement group_id="O2" value="1.0" spread="1.41"/>
                    <measurement group_id="O3" value="0.9" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale</title>
        <description>Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>OnabotulinumtoxinA 400 U</title>
            <description>OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>OnabotulinumtoxinA 200 U</title>
            <description>OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale</title>
          <description>Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.</description>
          <population>Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.50" spread="1.243"/>
                    <measurement group_id="O2" value="6.84" spread="1.342"/>
                    <measurement group_id="O3" value="6.63" spread="1.157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.48" spread="1.894"/>
                    <measurement group_id="O2" value="-2.07" spread="2.126"/>
                    <measurement group_id="O3" value="-1.80" spread="1.896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Day 172</time_frame>
      <group_list>
        <group group_id="E1">
          <title>OnabotulinumtoxinA 400 U</title>
          <description>OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>OnabotulinumtoxinA 200 U</title>
          <description>OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</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="6" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Incision site infection</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Basal ganglia infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</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="9" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="89"/>
              </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/NCT02230956
org study id: 191622-145
secondary id: 2014-001076-58
nct id: NCT02230956
lead sponsor: 
has dmc: No
This study will evaluate the efficacy and safety of a single intra-articular injection of 2
      doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee
      osteoarthritis symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
time frame: Baseline, Week 8
description: Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
measure: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale
time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
description: The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.
measure: Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale
time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
description: The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.
measure: Patient Global Impression of Change (GIC) Using a 7-Point Scale
time frame: Weeks 1, 4, 8, 12, 16, 20 and 24
description: The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.
measure: Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale
time frame: Baseline, Week 24
description: Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
arm group label: OnabotulinumtoxinA 400 U
arm group type: Experimental
description: OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
arm group label: OnabotulinumtoxinA 200 U
arm group type: Experimental
description: OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
intervention type: Biological
intervention name: onabotulinumtoxinA
description: onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
arm group label: OnabotulinumtoxinA 200 U
arm group label: OnabotulinumtoxinA 400 U
other name: botulinum toxin Type A
other name: BOTOX®
intervention type: Drug
intervention name: Normal Saline
description: Normal Saline (placebo) injection into the intra-articular space of the study knee.
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
facility: 
facility: 
country: Czechia
country: Denmark
country: United States
country: Czech Republic
url: http://www.allerganclinicaltrials.com
description: More Information
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
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: 