<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/NCT01724918</url>
  </required_header>
  <id_info>
    <org_study_id>LIVE 001</org_study_id>
    <nct_id>NCT01724918</nct_id>
  </id_info>
  <brief_title>Lacosamide IV and EEG/EKG (LIVE) Study</brief_title>
  <acronym>LIVE</acronym>
  <official_title>Lacosamide IV and EEG/EKG (LIVE) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UCB Pharma GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a&#xD;
      new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram)&#xD;
      rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those&#xD;
      doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG&#xD;
      (electrocardiogram), a test which checks for problems with the electrical activity of the&#xD;
      heart.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The impact of antiepileptic drugs on the EEG can vary from marked to none. A small number of&#xD;
      AEDs also affect the EKG. Lacosamide is a new AED that selectively enhances slow inactivation&#xD;
      of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal&#xD;
      membranes and inhibition of repetitive neuronal firing. Information is lacking about the&#xD;
      effect of lacosamide on brain and heart rhythms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.&#xD;
  </why_stopped>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the number of interictal spikes</measure>
    <time_frame>One hour before and after drug</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in frequency and quantity of background EEG rhythms</measure>
    <time_frame>One hour before and after drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EKG (QT, PR interval and heart rhythm)</measure>
    <time_frame>One hour before and after drug</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>Up to 4 hours after start of infusion</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Focal Epilepsy</condition>
  <arm_group>
    <arm_group_label>100 mg IV</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>100 mg IV lacosamide infused over 30 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg IV</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>200 mg IV lacosamide infused over 30 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>400 mg IV</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>400 mg IV lacosamide infused over 30 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacosamide</intervention_name>
    <arm_group_label>100 mg IV</arm_group_label>
    <arm_group_label>200 mg IV</arm_group_label>
    <arm_group_label>400 mg IV</arm_group_label>
    <other_name>Vimpat</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is informed and given ample time and opportunity to think about her/his&#xD;
             participation and has given her/his written informed consent.&#xD;
&#xD;
          2. Adult patients 18-65 years&#xD;
&#xD;
          3. Diagnosis of focal epilepsy&#xD;
&#xD;
          4. Continuous EEG and video monitoring&#xD;
&#xD;
          5. Continuous EKG&#xD;
&#xD;
          6. Active EEG showing frequent spikes, electrographic or clinical seizures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has no IV access.&#xD;
&#xD;
          2. Subject is hemodynamically unstable.&#xD;
&#xD;
          3. Previous use of Lacosamide&#xD;
&#xD;
          4. Primary generalized epilepsy&#xD;
&#xD;
          5. Non-epileptic seizures&#xD;
&#xD;
          6. No significant cardiac, renal or hepatic disease&#xD;
&#xD;
          7. No cardiac arrhythmias including heart block&#xD;
&#xD;
          8. Subject is a pregnant or lactating woman.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard McLachlan, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre, University Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foothills Medical Center</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal University Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>September 23, 2016</last_update_submitted>
  <last_update_submitted_qc>September 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Rick McLachlan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>IV lacosamide</keyword>
  <keyword>focal epilepsy</keyword>
  <keyword>EEG</keyword>
  <keyword>EKG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Epilepsies, Partial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacosamide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01724918
org study id: LIVE 001
nct id: NCT01724918
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a
      new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram)
      rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those
      doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG
      (electrocardiogram), a test which checks for problems with the electrical activity of the
      heart.
The impact of antiepileptic drugs on the EEG can vary from marked to none. A small number of
      AEDs also affect the EKG. Lacosamide is a new AED that selectively enhances slow inactivation
      of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal
      membranes and inhibition of repetitive neuronal firing. Information is lacking about the
      effect of lacosamide on brain and heart rhythms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in the number of interictal spikes
time frame: One hour before and after drug
measure: Change in frequency and quantity of background EEG rhythms
time frame: One hour before and after drug
measure: Change in EKG (QT, PR interval and heart rhythm)
time frame: One hour before and after drug
measure: Adverse events
time frame: Up to 4 hours after start of infusion
arm group label: 100 mg IV
arm group type: Other
description: 100 mg IV lacosamide infused over 30 minutes
arm group label: 200 mg IV
arm group type: Other
description: 200 mg IV lacosamide infused over 30 minutes
arm group label: 400 mg IV
arm group type: Other
description: 400 mg IV lacosamide infused over 30 minutes
intervention type: Drug
intervention name: Lacosamide
arm group label: 100 mg IV
arm group label: 200 mg IV
arm group label: 400 mg IV
other name: Vimpat
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Richard McLachlan, MD, FRCPC
role: Principal Investigator
affiliation: London Health Sciences Centre, University Campus
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Rick McLachlan
investigator title: Principal Investigator
mesh term: Epilepsy
mesh term: Epilepsies, Partial
mesh term: Lacosamide