<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/NCT02192814</url>
  </required_header>
  <id_info>
    <org_study_id>EP0024</org_study_id>
    <secondary_id>EP0024</secondary_id>
    <nct_id>NCT02192814</nct_id>
  </id_info>
  <brief_title>Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures</brief_title>
  <official_title>A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With Partial-onset Seizures With or Without Secondary Generalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Japan Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of&#xD;
      intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will&#xD;
      be administered for 5 days as replacement for oral LCM tablets in Japanese adults with&#xD;
      partial-onset seizures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Total Number of Subjects Experiencing at Least One Adverse Event During the Study</measure>
    <time_frame>During the study (Screening through End of Study (Day -1 through Day 6))</time_frame>
    <description>An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Total Number of Subject Withdrawal Due to Adverse Events During the Study</measure>
    <time_frame>During the study (Screening through End of Study (Day -1 through Day 6))</time_frame>
    <description>An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1</measure>
    <time_frame>20 minutes prior infusion at Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2</measure>
    <time_frame>20 minutes prior infusion at Day 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5</measure>
    <time_frame>20 minutes prior infusion at Day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1</measure>
    <time_frame>20 minutes prior infusion at Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2</measure>
    <time_frame>20 minutes prior infusion at Day 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5</measure>
    <time_frame>20 minutes prior infusion at Day 5</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5</measure>
    <time_frame>From Day -1 to Day 5</time_frame>
    <description>No descriptive statistics have been calculated for this exploratory Outcome Measure.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Epilepsy</condition>
  <condition>Partial-onset Seizures</condition>
  <arm_group>
    <arm_group_label>Lacosamide (LCM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacosamide (200 mg/20 mL)</intervention_name>
    <description>Active Substance: Lacosamide&#xD;
Pharmaceutical form: Solution for intravenous (iv) infusion&#xD;
Concentration: adapted on concentration of oral dose in EP0009&#xD;
Route of Administration: Drip infusion</description>
    <arm_group_label>Lacosamide (LCM)</arm_group_label>
    <other_name>Vimpat</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide&#xD;
             (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8&#xD;
             weeks&#xD;
&#xD;
          -  Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to&#xD;
             400 mg/ day, for the 2 weeks prior to entry into EP0024&#xD;
&#xD;
          -  Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at&#xD;
             doses that have remained stable for the 2 weeks prior to entry into EP0024&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a history of any kind of status epilepticus within 12-month period prior&#xD;
             to study entry&#xD;
&#xD;
          -  Subject has actual suicidal ideation as indicated by a positive response (&quot;Yes&quot;) to&#xD;
             either Question 4 or Question 5 of the &quot;Since Last Visit&quot; version of the&#xD;
             Columbia-Suicide Severity Rating Scale (C-SSRS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 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>1-877-822-9493</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>81027</name>
      <address>
        <city>Hamamatsu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81024</name>
      <address>
        <city>Kodaira</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81025</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81003</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81023</name>
      <address>
        <city>Suita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <results_first_submitted>October 30, 2015</results_first_submitted>
  <results_first_submitted_qc>October 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 4, 2015</results_first_posted>
  <last_update_submitted>July 28, 2017</last_update_submitted>
  <last_update_submitted_qc>July 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lacosamide</keyword>
  <keyword>LCM</keyword>
  <keyword>Epilepsy</keyword>
  <keyword>Partial-onset seizures</keyword>
  <keyword>iv</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Seizures</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 multicenter, open-label study started recruiting in June 2014.</recruitment_details>
      <pre_assignment_details>Participant Flow refers to the Safety Set (SS), consisting of all enrolled subjects who received at least 1 infusion of iv LCM.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lacosamide (LCM)</title>
          <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participant Flow refers to the Safety Set (SS), consisting of all enrolled subjects who received at least 1 infusion of iv LCM.&#xD;
Subjects participating in EP0009 (NCT01832038) have been enrolled to EP0024.</population>
      <group_list>
        <group group_id="B1">
          <title>Lacosamide (LCM)</title>
          <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="26.9" spread="10.0"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilogram (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.99" spread="13.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="159.07" spread="8.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Total Number of Subjects Experiencing at Least One Adverse Event During the Study</title>
        <description>An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
        <time_frame>During the study (Screening through End of Study (Day -1 through Day 6))</time_frame>
        <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide (LCM)</title>
            <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
          </group>
        </group_list>
        <measure>
          <title>The Total Number of Subjects Experiencing at Least One Adverse Event During the Study</title>
          <description>An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
          <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Total Number of Subject Withdrawal Due to Adverse Events During the Study</title>
        <description>An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
        <time_frame>During the study (Screening through End of Study (Day -1 through Day 6))</time_frame>
        <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide (LCM)</title>
            <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
          </group>
        </group_list>
        <measure>
          <title>The Total Number of Subject Withdrawal Due to Adverse Events During the Study</title>
          <description>An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
          <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1</title>
        <time_frame>20 minutes prior infusion at Day 1</time_frame>
        <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide (LCM)</title>
            <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1</title>
          <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.738" spread="50.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2</title>
        <time_frame>20 minutes prior infusion at Day 2</time_frame>
        <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide (LCM)</title>
            <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2</title>
          <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.004" spread="55.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5</title>
        <time_frame>20 minutes prior infusion at Day 5</time_frame>
        <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide (LCM)</title>
            <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5</title>
          <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.615" spread="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1</title>
        <time_frame>20 minutes prior infusion at Day 1</time_frame>
        <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide (LCM)</title>
            <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1</title>
          <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.838" spread="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2</title>
        <time_frame>20 minutes prior infusion at Day 2</time_frame>
        <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide (LCM)</title>
            <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2</title>
          <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.330" spread="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5</title>
        <time_frame>20 minutes prior infusion at Day 5</time_frame>
        <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
        <group_list>
          <group group_id="O1">
            <title>Lacosamide (LCM)</title>
            <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5</title>
          <population>The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.621" spread="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5</title>
        <description>No descriptive statistics have been calculated for this exploratory Outcome Measure.</description>
        <time_frame>From Day -1 to Day 5</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) were collected from Screening Period (Day -1) until End-of-Study Period (Day 6).</time_frame>
      <desc>Adverse Events refer to the Safety Set (SS) which constisted of all all enrolled subjects who received at least 1 infusion of iv LCM.</desc>
      <group_list>
        <group group_id="E1">
          <title>Lacosamide (LCM)</title>
          <description>On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.&#xD;
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.&#xD;
The daily dose of iv LCM was be the same as the subject's current daily dose of oral LCM in EP0009 (200 - 400 mg/day).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.1</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="4" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </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 Clinical Trial Call Center</name_or_title>
      <organization>UCB Pharma</organization>
      <phone>+1877 822 ext 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/NCT02192814
org study id: EP0024
secondary id: EP0024
nct id: NCT02192814
lead sponsor: 
collaborator: 
has dmc: No
EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of
      intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will
      be administered for 5 days as replacement for oral LCM tablets in Japanese adults with
      partial-onset seizures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Total Number of Subjects Experiencing at Least One Adverse Event During the Study
time frame: During the study (Screening through End of Study (Day -1 through Day 6))
description: An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
measure: The Total Number of Subject Withdrawal Due to Adverse Events During the Study
time frame: During the study (Screening through End of Study (Day -1 through Day 6))
description: An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
measure: Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1
time frame: 20 minutes prior infusion at Day 1
measure: Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2
time frame: 20 minutes prior infusion at Day 2
measure: Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5
time frame: 20 minutes prior infusion at Day 5
measure: Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1
time frame: 20 minutes prior infusion at Day 1
measure: Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2
time frame: 20 minutes prior infusion at Day 2
measure: Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5
time frame: 20 minutes prior infusion at Day 5
measure: The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5
time frame: From Day -1 to Day 5
description: No descriptive statistics have been calculated for this exploratory Outcome Measure.
arm group label: Lacosamide (LCM)
arm group type: Experimental
description: On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.
During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.
The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).
intervention type: Drug
intervention name: Lacosamide (200 mg/20 mL)
description: Active Substance: Lacosamide
Pharmaceutical form: Solution for intravenous (iv) infusion
Concentration: adapted on concentration of oral dose in EP0009
Route of Administration: Drip infusion
arm group label: Lacosamide (LCM)
other name: Vimpat
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: UCB Clinical Trial Call Center
role: Study Director
affiliation: 1-877-822-9493
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
url: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Seizures
mesh term: Lacosamide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 