<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/NCT01673282</url>
  </required_header>
  <id_info>
    <org_study_id>SP1065</org_study_id>
    <nct_id>NCT01673282</nct_id>
  </id_info>
  <brief_title>Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy</brief_title>
  <acronym>VICTOS</acronym>
  <official_title>A Non-interventional, Observational Study Evaluating Changes in Drug Load and Seizure Frequency Using Vimpat (Lacosamide) in Daily Clinical Practice in Combination Therapy With Sodium Channel Blocking Anti-epileptic Drugs (AEDs) or Non Sodium Channel Blocking AEDs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Pharma GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in&#xD;
      clinical practice and will also evaluate the subsequent change in the drug load of patients&#xD;
      after addition of VIMPAT® to their treatment regimen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)</measure>
    <time_frame>From Baseline (Day 0) to 6 months</time_frame>
    <description>Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">315</enrollment>
  <condition>Focal Epilepsy With and Without Secondary Generalization</condition>
  <arm_group>
    <arm_group_label>Vimpat + Na Channel Blocking AED</arm_group_label>
    <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vimpat + Non-Na Channel Blocking AED</arm_group_label>
    <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacosamide</intervention_name>
    <description>Route of Administration: oral/subcutaneous Form and Dosage: Tablet (50 mg/100 mg/150 mg, 200 mg); Syrup (10 mg/ml); Solution for infusion (10 mg/ml).</description>
    <arm_group_label>Vimpat + Na Channel Blocking AED</arm_group_label>
    <arm_group_label>Vimpat + Non-Na Channel Blocking AED</arm_group_label>
    <other_name>Vimpat</other_name>
    <other_name>LCM</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with focal epilepsy with or without secondary generalization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has not received Vimpat® more than 7 days prior to start of&#xD;
             Non-Interventional Study (NIS)&#xD;
&#xD;
          -  The patient must have a diagnosis of epilepsy with partial-onset seizures with or&#xD;
             without secondary generalization&#xD;
&#xD;
          -  Based on the physician's clinical judgment, it is in the patient's best interest to be&#xD;
             prescribed adjunctive Vimpat® (ie, the decision to prescribe Vimpat® is made by the&#xD;
             physician)&#xD;
&#xD;
          -  Patient must be at least 18 years of age&#xD;
&#xD;
          -  The patient must have had at least one seizure within the last 3 months prior to&#xD;
             enrolment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Clinical Trial Call Center</last_name>
    <role>Study Director</role>
    <affiliation>UCB Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>60</name>
      <address>
        <city>Innsbruck</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>61</name>
      <address>
        <city>Mauer bei Amstetten</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>63</name>
      <address>
        <city>Ried</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>18</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>34</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>43</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>66</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>23</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>25</name>
      <address>
        <city>Dortmund</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>35</name>
      <address>
        <city>Duesseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>48</name>
      <address>
        <city>Erbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>59</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>30</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>47</name>
      <address>
        <city>Giessen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>29</name>
      <address>
        <city>Goettingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>37</name>
      <address>
        <city>Goettingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>05</name>
      <address>
        <city>Haag</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>12</name>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>19</name>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>39</name>
      <address>
        <city>Heidenheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>54</name>
      <address>
        <city>Ibbenbueren</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>27</name>
      <address>
        <city>Jena</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>04</name>
      <address>
        <city>Jülich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>13</name>
      <address>
        <city>Kehl-Kork</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>36</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>28</name>
      <address>
        <city>Koeln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>40</name>
      <address>
        <city>Koeln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>38</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>52</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>67</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>49</name>
      <address>
        <city>Mittweida</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>01</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>08</name>
      <address>
        <city>Oranienburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>17</name>
      <address>
        <city>Osnabrück</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>14</name>
      <address>
        <city>Radeberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>15</name>
      <address>
        <city>Rüsselsheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>16</name>
      <address>
        <city>Senftenberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>41</name>
      <address>
        <city>Stuttgart</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>09</name>
      <address>
        <city>Troisdorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>22</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>20</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>07</name>
      <address>
        <city>Westerstede</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>June 29, 2016</results_first_submitted>
  <results_first_submitted_qc>September 26, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 15, 2016</results_first_posted>
  <last_update_submitted>September 26, 2016</last_update_submitted>
  <last_update_submitted_qc>September 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lacosamide</keyword>
  <keyword>Vimpat</keyword>
  <keyword>Focal Epilepsy</keyword>
  <keyword>Drug Load</keyword>
  <keyword>AED</keyword>
  <keyword>SP1065</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Epilepsies, Partial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacosamide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study started to enroll subjects in Austria and Germany in July 2012 and concluded in July 2015.</recruitment_details>
      <pre_assignment_details>The Participant Flow consists of subjects in the Safety Set (SS) which received at least 1 dose of VIMPAT. Of the 315 enrolled subjects 311 were included in the SS.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Vimpat + Na Channel Blocking AED</title>
          <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.</description>
        </group>
        <group group_id="P2">
          <title>Vimpat + Non-Na Channel Blocking AED</title>
          <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="153"/>
                <participants group_id="P2" count="158"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Drug Reaction - Vimpat</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The analysis group for Baseline Characteristics is the Safety Set (SS). The Safety Set consists of all patients who received at least 1 dose of Lacosamide.</population>
      <group_list>
        <group group_id="B1">
          <title>Vimpat + Na Channel Blocking AED</title>
          <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.</description>
        </group>
        <group group_id="B2">
          <title>Vimpat + Non-Na Channel Blocking AED</title>
          <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.</description>
        </group>
        <group group_id="B3">
          <title>Total Title</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="153"/>
            <count group_id="B2" value="158"/>
            <count group_id="B3" value="311"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="252"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="44.0" spread="16.4"/>
                    <measurement group_id="B2" value="52.5" spread="16.0"/>
                    <measurement group_id="B3" value="48.3" spread="16.7"/>
                  </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="79"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)</title>
        <description>Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.</description>
        <time_frame>From Baseline (Day 0) to 6 months</time_frame>
        <population>The analysis group for the outcome measure is the Full Analysis Set (FAS). The FAS included all patients who received at least 1 dose of Lacosamide and for whom at least 1 valid ratio of dose and DDD at Baseline and post-Baseline could be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Vimpat + Na Channel Blocking AED</title>
            <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.</description>
          </group>
          <group group_id="O2">
            <title>Vimpat + Non-Na Channel Blocking AED</title>
            <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)</title>
          <description>Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.</description>
          <population>The analysis group for the outcome measure is the Full Analysis Set (FAS). The FAS included all patients who received at least 1 dose of Lacosamide and for whom at least 1 valid ratio of dose and DDD at Baseline and post-Baseline could be calculated.</population>
          <units>percent change of ratio in dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.0" spread="64.8"/>
                    <measurement group_id="O2" value="-4.4" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Based on an ANCOVA model for absolute change in ratio of dose and DDD with group as a fixed effect and the ratio of dose and DDD at Baseline as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0003</p_value>
            <method>ANCOVA</method>
            <param_type>Least Square Mean</param_type>
            <param_value>-0.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.36</ci_lower_limit>
            <ci_upper_limit>-0.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the entire study period (day 0 - month 6)</time_frame>
      <desc>All patients who received at least 1 dose of Lacosamide were included in the SS.</desc>
      <group_list>
        <group group_id="E1">
          <title>Vimpat + Na Channel Blocking AED</title>
          <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.</description>
        </group>
        <group group_id="E2">
          <title>Vimpat + Non-Na Channel Blocking AED</title>
          <description>Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRAv18.0</default_vocab>
        <default_assessment>Non-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="153"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse event</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="153"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRAv18.0</default_vocab>
        <default_assessment>Non-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="22" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drug ineffective</sub_title>
                <description>Adverse event terminology as reported by the investigator.</description>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="153"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="158"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Off label use</sub_title>
                <description>Adverse event terminology as reported by the investigator.</description>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="153"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="158"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <description>Overdose was defined as any Vimpat dose that was higher than the maximum approved dose of 400 mg/day. Adverse event terminology as reported by the investigator.</description>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="153"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="158"/>
              </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>The only 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>UCB (Study Director)</name_or_title>
      <organization>UCB Cares</organization>
      <phone>+1 887 822 9493</phone>
    </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/NCT01673282
org study id: SP1065
nct id: NCT01673282
lead sponsor: 
has dmc: No
This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in
      clinical practice and will also evaluate the subsequent change in the drug load of patients
      after addition of VIMPAT® to their treatment regimen.
observational model: Cohort
time perspective: Prospective
measure: The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)
time frame: From Baseline (Day 0) to 6 months
description: Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
arm group label: Vimpat + Na Channel Blocking AED
description: Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
arm group label: Vimpat + Non-Na Channel Blocking AED
description: Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
intervention type: Drug
intervention name: Lacosamide
description: Route of Administration: oral/subcutaneous Form and Dosage: Tablet (50 mg/100 mg/150 mg, 200 mg); Syrup (10 mg/ml); Solution for infusion (10 mg/ml).
arm group label: Vimpat + Na Channel Blocking AED
arm group label: Vimpat + Non-Na Channel Blocking AED
other name: Vimpat
other name: LCM
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: UCB Clinical Trial Call Center
role: Study Director
affiliation: UCB Pharma
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country: Austria
country: Germany
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Seizures
mesh term: Epilepsies, Partial
mesh term: Lacosamide
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