<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/NCT03796962</url>
  </required_header>
  <id_info>
    <org_study_id>XPF-008-201</org_study_id>
    <secondary_id>2018-003221-29</secondary_id>
    <nct_id>NCT03796962</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy</brief_title>
  <acronym>X-TOLE</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xenon Pharmaceuticals Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novotech Health Holdings Pte. Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xenon Pharmaceuticals Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study&#xD;
      that will evaluate the clinical efficacy, safety and tolerability of increasing doses of&#xD;
      XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy,&#xD;
      followed by an optional open-label extension (OLE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The XEN1101 Phase 2 clinical trial is designed as a randomized, double-blind,&#xD;
      placebo-controlled, multicenter study with an optional open-label extension (OLE) to evaluate&#xD;
      the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive&#xD;
      treatment in adult patients aged 18 to 75 years diagnosed with focal epilepsy. Approximately&#xD;
      300 patients will be randomized in a blinded manner to one of three active treatment groups&#xD;
      or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). After screening,&#xD;
      patients will have 8 weeks of baseline to assess frequency of seizures, followed by 8 weeks&#xD;
      of treatment and a 6-week post treatment follow-up period. In order to be included in the&#xD;
      study, patients must already be treated with a stable dose of 1 to 3 allowable current&#xD;
      anti-epileptic drugs for at least one month prior to screening, during baseline, and&#xD;
      throughout the double-blind portion (DBP) of the study. During the treatment period, patients&#xD;
      will be given XEN1101 or placebo once daily in the evening. A five year OLE will be available&#xD;
      to eligible patients who complete the DBP. All patients will receive a 20 mg daily dose of&#xD;
      XEN1101 during this extension period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">October 2026</completion_date>
  <primary_completion_date type="Actual">September 2, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency (e.g., median percent change in focal seizure frequency) in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs) in the double-blind treatment period (DBP)</measure>
    <time_frame>From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)</time_frame>
    <description>Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To assess the safety and tolerability of XEN1101 (e.g., adverse events) in adults with focal epilepsy taking 1-3 AEDs</measure>
    <time_frame>From screening (up to 28 days prior to baseline) through to 42 days post-final dose</time_frame>
    <description>To assess adverse events as criteria for safety and tolerability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the 50% XEN1101 response rates in comparison to placebo in the DBP</measure>
    <time_frame>From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)</time_frame>
    <description>Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate trends in focal seizure frequency over time in the DBP</measure>
    <time_frame>From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)</time_frame>
    <description>Percent change from baseline in weekly focal seizure frequency for each week in the DBP</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">325</enrollment>
  <condition>Focal Epilepsy</condition>
  <arm_group>
    <arm_group_label>25 mg XEN1101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsule filled with 25 mg XEN1101</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 mg XEN1101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsule filled with 20 mg XEN1101</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 mg XEN1101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsule filled with 10 mg XEN1101</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XEN1101</intervention_name>
    <description>Oral dose</description>
    <arm_group_label>10 mg XEN1101</arm_group_label>
    <arm_group_label>20 mg XEN1101</arm_group_label>
    <arm_group_label>25 mg XEN1101</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Be properly informed of the nature and risks of the study and give informed consent in&#xD;
             writing, prior to entering the study&#xD;
&#xD;
          -  BMI ≤40 kg/m2&#xD;
&#xD;
          -  Diagnosis (≥2 years) of focal epilepsy according to the International League Against&#xD;
             Epilepsy [ILAE] Classification of Epilepsy (2017)&#xD;
&#xD;
          -  Prior neuroimaging within the last 10 years and documentation is available&#xD;
&#xD;
          -  Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month&#xD;
             prior to screening, during baseline, and throughout the duration of the DBP&#xD;
&#xD;
          -  Must be willing to comply with the contraception requirements&#xD;
&#xD;
          -  Males must agree not to donate sperm from the time of the first administration of&#xD;
             study drug until 6 months after the last dose. Females must agree not to donate ova&#xD;
             from the time of the first administration of study drug until 6 months after the last&#xD;
             dose.&#xD;
&#xD;
          -  Able to keep accurate seizure diaries&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History of pseudoseizures, psychogenic seizures, primary generalized seizure, or focal&#xD;
             aware non-motor seizures only&#xD;
&#xD;
          -  Presence or previous history of Lennox-Gastaut syndrome&#xD;
&#xD;
          -  Seizures secondary to other diseases or conditions&#xD;
&#xD;
          -  History of repetitive seizures within the last 12 months where the individual seizures&#xD;
             cannot be counted&#xD;
&#xD;
          -  History of neurosurgery for seizures &lt;1 year prior to enrollment, or radiosurgery &lt;2&#xD;
             years prior to enrollment&#xD;
&#xD;
          -  Schizophrenia and other psychotic disorders, or active suicidal plan/intent in the&#xD;
             past 6 months, or a history of suicide attempt in the last 2 years, or more than 1&#xD;
             lifetime suicide attempt&#xD;
&#xD;
          -  History or presence of any significant medical or surgical condition or uncontrolled&#xD;
             medical illness at screening, or history of cancer within the past 2 years, with the&#xD;
             exception of appropriately treated basal cell or squamous cell carcinoma&#xD;
&#xD;
          -  Any clinically significant abnormalities on pre-study physical examination, vital&#xD;
             signs, laboratory values or ECG indicating a medical problem that would preclude study&#xD;
             participation including but not limited to:&#xD;
&#xD;
               1. History of presence of long QT syndrome; QTcF &gt; 450 msec at baseline; family&#xD;
                  history of sudden death of unknown cause&#xD;
&#xD;
               2. History of skin or retinal pigment epithelium abnormalities caused by ezogabine&#xD;
&#xD;
          -  Past use of vigabatrin without stable visual fields tested twice over the 12 months&#xD;
             after the last dose of vigabatrin (concomitant use of vigabatrin is not allowed)&#xD;
&#xD;
          -  If felbamate is used as a concomitant AED, patients must be taking it for at least 2&#xD;
             years, with a stable dose for 2 months (or no less than 49 days) and acceptable&#xD;
             hematology and LFT history and values prior to Screening. If received in the past,&#xD;
             felbamate must have been discontinued 2 months (or no less than 49 days) prior to&#xD;
             Screening.&#xD;
&#xD;
          -  Have had multiple drug allergies or a severe drug reaction to an AED(s), including&#xD;
             dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity&#xD;
             reactions&#xD;
&#xD;
          -  Current use of a ketogenic diet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Xenon Pharmaceuticals Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strada Patient Care Center</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xenoscience, Inc.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials, Inc.</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altman Clinical Translational Research Institute (ACTRI)</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital Anschutz Outpatient Pavilion</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visionary Investigators Network</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Don Clinical Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Neurology Research Group, LLC.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Orlando, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medsol Clinical Research Center</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Neurological Clinic</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Neurology and Sleep Medicine Associate</name>
      <address>
        <city>Suwanee</city>
        <state>Georgia</state>
        <zip>30024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hawaii Pacific Neuroscience</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultants in Epilepsy and Neurology, PLLC</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Medical Group, Department of Neurology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bluegrass Epilepsy Research</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Partners Neurology</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Atlantic Epilepsy and Sleep Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Neuro Research Center</name>
      <address>
        <city>South Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Clinic of Neurology, Ltd.</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Epilepsy Group, P. A.</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Regional Epilepsy Group</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Neurology and Neurosurgery at Saint Barnabas</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Regional Epilepsy Group</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dent Neurosciences Research Center</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center/NYU School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health - Lenox Hill</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University Institute for Human Performance</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Five Towns Neuroscience Research</name>
      <address>
        <city>Woodmere</city>
        <state>New York</state>
        <zip>11598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asheville Neurology Specialists, PA</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Gardner Neuroscience Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Valley Hospital</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toledo Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Neurological Specialties East</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Comprehensive Epilepsy Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Neurological Associates</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Epilepsy Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Epilepsy Care Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James W. Aston Ambulatory Care Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229-3900</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Health Clinical Neurosciences Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carilion Neurology Clinic</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winchester Neurological Consultants</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UW Medicine Valle Medical Center</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington School of Medicine, Regional Epilepsy Center at Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's and Women's Health Centre of British Columbia (BC Children's Hospital)</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Center</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network-Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Arensia Exploratory Medicine</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epilepsiezentrum Berlin-Brandenburg</name>
      <address>
        <city>Berlin</city>
        <zip>10365</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethel Epilepsy Centre</name>
      <address>
        <city>Bielefeld</city>
        <zip>33617</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ.-Klinik Bonn, Klinik und Poliklinik fur Epileptologie</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikym Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60528</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Freiburg, Neurozentrum/Epilepsiezentrum</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Munster (UKM)</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Osnabruck</name>
      <address>
        <city>Osnabrück</city>
        <zip>49076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Barmherzige Brueder Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tubingen-Dept. of Neurology and Epileptology</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS- Istituto delle Scienze Neurologiche, Bellaria Hospital</name>
      <address>
        <city>Bologna</city>
        <zip>40139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dipartimento Scienze Mediche e Chirurgiche, Universita Magna Graecia di Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Neurologico C. Besta</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Neurologico Nazionale C. Mondino</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universita' Pisana</name>
      <address>
        <city>Pisa</city>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera &quot;Bianchi-Melacrino-Morelle&quot;di Reggio Calabria</name>
      <address>
        <city>Reggio Calabria</city>
        <zip>89123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico di Roma Umberto I</name>
      <address>
        <city>Roma</city>
        <zip>00185</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMSI Republican Clinical Hospital, ARENSIA Exploratory Medicine</name>
      <address>
        <city>Chisinau</city>
        <zip>2025</zip>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <state>Andalusia</state>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Neurologia Avanzada</name>
      <address>
        <city>Sevilla</city>
        <state>Andalusia</state>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias I Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Universidad Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vithas La Salud</name>
      <address>
        <city>Granada</city>
        <zip>18008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital U. Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ruber Internacional</name>
      <address>
        <city>Madrid</city>
        <zip>28036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital U. Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Málaga</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politécnico La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of Limited Liability Company &quot;Harmoniya Krasy&quot;</name>
      <address>
        <city>Kyiv</city>
        <zip>01135</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Neurological Sciences</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <zip>G514TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. George's University Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Moldova, Republic of</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <disposition_first_submitted>August 18, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>August 18, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 23, 2022</disposition_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epilepsy</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>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03796962
org study id: XPF-008-201
secondary id: 2018-003221-29
nct id: NCT03796962
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study
      that will evaluate the clinical efficacy, safety and tolerability of increasing doses of
      XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy,
      followed by an optional open-label extension (OLE).
The XEN1101 Phase 2 clinical trial is designed as a randomized, double-blind,
      placebo-controlled, multicenter study with an optional open-label extension (OLE) to evaluate
      the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive
      treatment in adult patients aged 18 to 75 years diagnosed with focal epilepsy. Approximately
      300 patients will be randomized in a blinded manner to one of three active treatment groups
      or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). After screening,
      patients will have 8 weeks of baseline to assess frequency of seizures, followed by 8 weeks
      of treatment and a 6-week post treatment follow-up period. In order to be included in the
      study, patients must already be treated with a stable dose of 1 to 3 allowable current
      anti-epileptic drugs for at least one month prior to screening, during baseline, and
      throughout the double-blind portion (DBP) of the study. During the treatment period, patients
      will be given XEN1101 or placebo once daily in the evening. A five year OLE will be available
      to eligible patients who complete the DBP. All patients will receive a 20 mg daily dose of
      XEN1101 during this extension period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency (e.g., median percent change in focal seizure frequency) in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs) in the double-blind treatment period (DBP)
time frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
description: Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo
measure: To assess the safety and tolerability of XEN1101 (e.g., adverse events) in adults with focal epilepsy taking 1-3 AEDs
time frame: From screening (up to 28 days prior to baseline) through to 42 days post-final dose
description: To assess adverse events as criteria for safety and tolerability
measure: To evaluate the 50% XEN1101 response rates in comparison to placebo in the DBP
time frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
description: Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP
measure: To evaluate trends in focal seizure frequency over time in the DBP
time frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
description: Percent change from baseline in weekly focal seizure frequency for each week in the DBP
arm group label: 25 mg XEN1101
arm group type: Experimental
description: Capsule filled with 25 mg XEN1101
arm group label: 20 mg XEN1101
arm group type: Experimental
description: Capsule filled with 20 mg XEN1101
arm group label: 10 mg XEN1101
arm group type: Experimental
description: Capsule filled with 10 mg XEN1101
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule
intervention type: Drug
intervention name: XEN1101
description: Oral dose
arm group label: 10 mg XEN1101
arm group label: 20 mg XEN1101
arm group label: 25 mg XEN1101
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Xenon Pharmaceuticals Inc.
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country: Canada
country: Georgia
country: Germany
country: Italy
country: Moldova, Republic of
country: Spain
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Epilepsies, Partial