<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/NCT01710657</url>
  </required_header>
  <id_info>
    <org_study_id>EP0008</org_study_id>
    <secondary_id>2014-003622-41</secondary_id>
    <secondary_id>JapicCTI-121988</secondary_id>
    <nct_id>NCT01710657</nct_id>
  </id_info>
  <brief_title>A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures</brief_title>
  <official_title>A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Pharma SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UCB Japan Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of&#xD;
      orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and&#xD;
      Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary&#xD;
      generalization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period</measure>
    <time_frame>8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)</time_frame>
    <description>Partial-onset seizure (POS) frequency per 28 days was calculated as:&#xD;
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.&#xD;
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)</measure>
    <time_frame>8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period</measure>
    <time_frame>8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)</time_frame>
    <description>Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)</measure>
    <time_frame>8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)</time_frame>
    <description>Partial-onset seizure (POS) frequency per 28 days was calculated as:&#xD;
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.&#xD;
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">548</enrollment>
  <condition>Epilepsy</condition>
  <condition>Partial Onset Seizures</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lacosamide 200 mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lacosamide 400 mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacosamide 50 mg</intervention_name>
    <description>Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use</description>
    <arm_group_label>Lacosamide 200 mg/day</arm_group_label>
    <arm_group_label>Lacosamide 400 mg/day</arm_group_label>
    <other_name>Vimpat</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacosamide 100 mg</intervention_name>
    <description>Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
    <arm_group_label>Lacosamide 200 mg/day</arm_group_label>
    <arm_group_label>Lacosamide 400 mg/day</arm_group_label>
    <other_name>Vimpat</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching oral Placebo tablets twice daily for 16 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT)&#xD;
             scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy&#xD;
             with Partial-Onset Seizures according to the International Classification of Epileptic&#xD;
             Seizures (1981)&#xD;
&#xD;
          -  Subject must have been observed to have Partial-Onset Seizures for at least the&#xD;
             previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs&#xD;
             (AEDs)(concurrently or sequentially) and must have been observed to have on average at&#xD;
             least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21&#xD;
             days in the 8-Week Period prior to entry into the Baseline Period. In the case of&#xD;
             Simple Partial Seizures, only those with motor signs will be counted towards meeting&#xD;
             the inclusion criterion&#xD;
&#xD;
          -  Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs&#xD;
             (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS&#xD;
             must have been in place for at least 6 months prior to study entry. The dosage of&#xD;
             concomitant AED therapy and the settings of the VNS must be kept constant for a period&#xD;
             of at least 4 weeks prior to entry into the Baseline Period&#xD;
&#xD;
          -  Minimum Body Weight of 40 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a lifetime history of suicide attempt (including an active attempt,&#xD;
             interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6&#xD;
             months as indicated by a positive response (&quot;Yes&quot;) to either Question 4 or Question 5&#xD;
             of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening&#xD;
&#xD;
          -  Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders,&#xD;
             or other non-epileptical events that could be confused with Seizures&#xD;
&#xD;
          -  Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting&#xD;
             less than 30 minutes in which several Seizures occur with such frequency that the&#xD;
             initiation and completion of each individual Seizure cannot be distinguished) during&#xD;
             the 8-Week Period prior to Visit 1&#xD;
&#xD;
          -  Subject has a history of Primary Generalized Seizures&#xD;
&#xD;
          -  Subject with a history of Status Epilepticus within the 12-Months Period prior to&#xD;
             Visit 1&#xD;
&#xD;
          -  Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1&#xD;
&#xD;
          -  Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric&#xD;
             illness that may impair reliable participation in the study or necessitate the use of&#xD;
             medication not allowed by the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>70 Years</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 (UCB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>86026</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86027</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86015</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86005</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86032</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86006</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86031</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86009</name>
      <address>
        <city>Guanghzou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86007</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86008</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86013</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86016</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86014</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86010</name>
      <address>
        <city>Harbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86019</name>
      <address>
        <city>Jinan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86004</name>
      <address>
        <city>Kunming</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86011</name>
      <address>
        <city>Nanchang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86012</name>
      <address>
        <city>Nanchang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86028</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86003</name>
      <address>
        <city>Qingdao</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86001</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86023</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86025</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86021</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86020</name>
      <address>
        <city>Shijiazhuang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86022</name>
      <address>
        <city>Suzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86002</name>
      <address>
        <city>Taiyuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86018</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86024</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86017</name>
      <address>
        <city>Xi'An</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>86029</name>
      <address>
        <city>Xiamen</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81056</name>
      <address>
        <city>Asaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81030</name>
      <address>
        <city>Fujisawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81013</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81054</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81057</name>
      <address>
        <city>Hachinohe</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81008</name>
      <address>
        <city>Hakodate</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81027</name>
      <address>
        <city>Hamamatsu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81004</name>
      <address>
        <city>Himeji</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81018</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81019</name>
      <address>
        <city>Iwanuma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81012</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81033</name>
      <address>
        <city>Kitakyusyu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81017</name>
      <address>
        <city>Kobe</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>81010</name>
      <address>
        <city>Kokubunji</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81032</name>
      <address>
        <city>Koushi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81014</name>
      <address>
        <city>Kurume</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81047</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81035</name>
      <address>
        <city>Nagakute</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81028</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81029</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81040</name>
      <address>
        <city>Nara</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81007</name>
      <address>
        <city>Neyagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81002</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81046</name>
      <address>
        <city>Ohmura</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81005</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81009</name>
      <address>
        <city>Osakasayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81011</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81042</name>
      <address>
        <city>Sakai</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>81048</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81053</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81020</name>
      <address>
        <city>Sendai</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81031</name>
      <address>
        <city>Sendai</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81021</name>
      <address>
        <city>Shimotsuke</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81022</name>
      <address>
        <city>Shimotsuke</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81026</name>
      <address>
        <city>Shinjuku</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>
    <facility>
      <name>81051</name>
      <address>
        <city>Suita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81052</name>
      <address>
        <city>Suita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81016</name>
      <address>
        <city>Takatsuki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81006</name>
      <address>
        <city>Toyonaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81050</name>
      <address>
        <city>Ube</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>81001</name>
      <address>
        <city>Yamagata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <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>
  <results_reference>
    <citation>Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.</citation>
    <PMID>23859801</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <results_first_submitted>January 22, 2015</results_first_submitted>
  <results_first_submitted_qc>January 22, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 9, 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>Epilepsy</keyword>
  <keyword>Partial Onset Seizures</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>A total of 676 subjects with uncontrolled partial-onset seizures (of the 676 subjects, the number of Chinese subjects and Japanese subjects was planned to be 507 and 169, respectively) was planned to be screened and 540 subjects were planned to be enrolled in all regions of Japan and China.</recruitment_details>
      <pre_assignment_details>Overall, 692 subjects were screened and 548 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 547 subjects were included in the Safety Set.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Matching Placebo for 16 weeks.&#xD;
Placebo: Matching oral Placebo tablets twice daily for 16 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Lacosamide 200 mg/Day</title>
          <description>Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
        </group>
        <group group_id="P3">
          <title>Lacosamide 400 mg/Day</title>
          <description>Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="184"/>
                <participants group_id="P2" count="183"/>
                <participants group_id="P3" count="180"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Titration Period (4 Weeks)</title>
              <participants_list>
                <participants group_id="P1" count="184"/>
                <participants group_id="P2" count="183"/>
                <participants group_id="P3" count="180"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Maintenance Period (12 Weeks)</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
                <participants group_id="P2" count="175"/>
                <participants group_id="P3" count="168"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="166"/>
                <participants group_id="P2" count="171"/>
                <participants group_id="P3" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="32"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Baseline Characteristics refer to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Matching Placebo for 16 weeks.&#xD;
Placebo: Matching oral Placebo tablets twice daily for 16 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Lacosamide 200 mg/Day</title>
          <description>Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
        </group>
        <group group_id="B3">
          <title>Lacosamide 400 mg/Day</title>
          <description>Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</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="184"/>
            <count group_id="B2" value="183"/>
            <count group_id="B3" value="180"/>
            <count group_id="B4" value="547"/>
          </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="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="164"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="164"/>
                    <measurement group_id="B4" value="491"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </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="31.8" spread="12.0"/>
                    <measurement group_id="B2" value="33.2" spread="12.2"/>
                    <measurement group_id="B3" value="32.3" spread="11.9"/>
                    <measurement group_id="B4" value="32.4" spread="12.0"/>
                  </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="82"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="247"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="104"/>
                    <measurement group_id="B4" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                    <measurement group_id="B2" value="183"/>
                    <measurement group_id="B3" value="180"/>
                    <measurement group_id="B4" value="547"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Chinese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="136"/>
                    <measurement group_id="B3" value="133"/>
                    <measurement group_id="B4" value="405"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period</title>
        <description>Partial-onset seizure (POS) frequency per 28 days was calculated as:&#xD;
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.&#xD;
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.</description>
        <time_frame>8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)</time_frame>
        <population>The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Matching Placebo for 16 weeks.&#xD;
Placebo: Matching oral Placebo tablets twice daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Lacosamide 200 mg/Day</title>
            <description>Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
          </group>
          <group group_id="O3">
            <title>Lacosamide 400 mg/Day</title>
            <description>Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period</title>
          <description>Partial-onset seizure (POS) frequency per 28 days was calculated as:&#xD;
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.&#xD;
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.</description>
          <population>The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.</population>
          <units>Seizures per 28 days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.22" lower_limit="-93.0" upper_limit="39.8"/>
                    <measurement group_id="O2" value="-3.33" lower_limit="-754.3" upper_limit="165.2"/>
                    <measurement group_id="O3" value="-4.50" lower_limit="-97.5" upper_limit="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.&#xD;
If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>% Reduction over Placebo</param_type>
            <param_value>39.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>30.5</ci_lower_limit>
            <ci_upper_limit>47.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.&#xD;
If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>% Reduction over Placebo</param_type>
            <param_value>29.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.7</ci_lower_limit>
            <ci_upper_limit>38.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)</title>
        <time_frame>8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)</time_frame>
        <population>The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Matching Placebo for 16 weeks.&#xD;
Placebo: Matching oral Placebo tablets twice daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Lacosamide 200 mg/Day</title>
            <description>Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
          </group>
          <group group_id="O3">
            <title>Lacosamide 400 mg/Day</title>
            <description>Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)</title>
          <population>The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="70"/>
                    <measurement group_id="O3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period</title>
        <description>Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.</description>
        <time_frame>8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)</time_frame>
        <population>The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Matching Placebo for 16 weeks.&#xD;
Placebo: Matching oral Placebo tablets twice daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Lacosamide 200 mg/Day</title>
            <description>Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
          </group>
          <group group_id="O3">
            <title>Lacosamide 400 mg/Day</title>
            <description>Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period</title>
          <description>Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.</description>
          <population>The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.</population>
          <units>percentage change</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.10" lower_limit="-97.6" upper_limit="233.5"/>
                    <measurement group_id="O2" value="-36.75" lower_limit="-100.0" upper_limit="185.5"/>
                    <measurement group_id="O3" value="-48.78" lower_limit="-100.0" upper_limit="346.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)</title>
        <description>Partial-onset seizure (POS) frequency per 28 days was calculated as:&#xD;
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.&#xD;
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.</description>
        <time_frame>8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)</time_frame>
        <population>The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Matching Placebo for 16 weeks.&#xD;
Placebo: Matching oral Placebo tablets twice daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Lacosamide 200 mg/Day</title>
            <description>Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
          </group>
          <group group_id="O3">
            <title>Lacosamide 400 mg/Day</title>
            <description>Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)</title>
          <description>Partial-onset seizure (POS) frequency per 28 days was calculated as:&#xD;
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.&#xD;
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.</description>
          <population>The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.</population>
          <units>Seizures per 28 days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
                <count group_id="O2" value="182"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.10" lower_limit="-102.4" upper_limit="102.5"/>
                    <measurement group_id="O2" value="-3.39" lower_limit="-670.0" upper_limit="138.9"/>
                    <measurement group_id="O3" value="-4.00" lower_limit="-92.4" upper_limit="34.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19).</time_frame>
      <desc>Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Matching Placebo for 16 weeks.&#xD;
Placebo: Matching oral Placebo tablets twice daily for 16 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Lacosamide 200 mg/Day</title>
          <description>Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
        </group>
        <group group_id="E3">
          <title>Lacosamide 400 mg/Day</title>
          <description>Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.&#xD;
Lacosamide 50 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 50 mg&#xD;
Route of Administration: Oral use&#xD;
Lacosamide 100 mg: - Active Substance: Lacosamide&#xD;
Pharmaceutical Form: Film-coated tablet&#xD;
Concentration: 100 mg&#xD;
Route of Administration: Oral use</description>
        </group>
      </group_list>
      <serious_events>
        <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, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="184"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="183"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Comminuted fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Grand mal convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Status epilepticus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Epileptic psychosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="183"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abortion induced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="183"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="77" subjects_at_risk="184"/>
                <counts group_id="E2" subjects_affected="87" subjects_at_risk="183"/>
                <counts group_id="E3" subjects_affected="112" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="184"/>
                <counts group_id="E2" events="8" subjects_affected="4" subjects_at_risk="183"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="184"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="183"/>
                <counts group_id="E3" events="18" subjects_affected="14" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="184"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="183"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="41" subjects_affected="24" subjects_at_risk="184"/>
                <counts group_id="E2" events="40" subjects_affected="28" subjects_at_risk="183"/>
                <counts group_id="E3" events="36" subjects_affected="29" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="31" subjects_affected="22" subjects_at_risk="184"/>
                <counts group_id="E2" events="14" subjects_affected="10" subjects_at_risk="183"/>
                <counts group_id="E3" events="28" subjects_affected="19" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="14" subjects_affected="8" subjects_at_risk="183"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="180"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="32" subjects_affected="24" subjects_at_risk="184"/>
                <counts group_id="E2" events="57" subjects_affected="33" subjects_at_risk="183"/>
                <counts group_id="E3" events="118" subjects_affected="63" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="184"/>
                <counts group_id="E2" events="26" subjects_affected="18" subjects_at_risk="183"/>
                <counts group_id="E3" events="21" subjects_affected="19" subjects_at_risk="180"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="21" subjects_affected="11" subjects_at_risk="184"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="183"/>
                <counts group_id="E3" events="32" subjects_affected="19" subjects_at_risk="180"/>
              </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</organization>
      <phone>+1 877 822 9493 (UCB)</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/NCT01710657
org study id: EP0008
secondary id: 2014-003622-41
secondary id: JapicCTI-121988
nct id: NCT01710657
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of
      orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and
      Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary
      generalization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
time frame: 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)
description: Partial-onset seizure (POS) frequency per 28 days was calculated as:
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.
measure: The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)
time frame: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
measure: Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period
time frame: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)
description: Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.
measure: Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)
time frame: 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)
description: Partial-onset seizure (POS) frequency per 28 days was calculated as:
POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.
A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo for 16 weeks.
arm group label: Lacosamide 200 mg/day
arm group type: Experimental
description: Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
arm group label: Lacosamide 400 mg/day
arm group type: Experimental
description: Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
intervention type: Drug
intervention name: Lacosamide 50 mg
description: Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use
arm group label: Lacosamide 200 mg/day
arm group label: Lacosamide 400 mg/day
other name: Vimpat
intervention type: Drug
intervention name: Lacosamide 100 mg
description: Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use
arm group label: Lacosamide 200 mg/day
arm group label: Lacosamide 400 mg/day
other name: Vimpat
intervention type: Drug
intervention name: Placebo
description: Matching oral Placebo tablets twice daily for 16 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 16 Years
maximum age: 70 Years
healthy volunteers: No
last name: UCB Clinical Trial Call Center
role: Study Director
affiliation: +1 877 822 9493 (UCB)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
country: Japan
url: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
citation: Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.
PMID: 23859801
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: 