<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/NCT03021018</url>
  </required_header>
  <id_info>
    <org_study_id>EP0087</org_study_id>
    <nct_id>NCT03021018</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting</brief_title>
  <official_title>A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study to Assess the Efficacy and Safety of Brivaracetam Administered Intravenously as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Biopharma S.P.R.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UCB Pharma</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 purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV)&#xD;
      compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy&#xD;
      Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">April 27, 2018</completion_date>
  <primary_completion_date type="Actual">April 27, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication</measure>
    <time_frame>During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)</time_frame>
    <description>This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram [EEG] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Next Seizure (Per Clinical Observation) or Rescue Medication</measure>
    <time_frame>During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)</time_frame>
    <description>This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed and not necessarily confirmed via electroencephalogram [EEG]) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration</measure>
    <time_frame>At 6 hours after the end of study drug administration</time_frame>
    <description>This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration</measure>
    <time_frame>At 8 hours after the end of study drug administration</time_frame>
    <description>This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration</measure>
    <time_frame>At 12 hours after the end of study drug administration</time_frame>
    <description>This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration</measure>
    <time_frame>During the 6 hours after the end of study drug administration</time_frame>
    <description>This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration</measure>
    <time_frame>During the 8 hours after the end of study drug administration</time_frame>
    <description>This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration</measure>
    <time_frame>During the 12 hours after the end of study drug administration</time_frame>
    <description>This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Brivaracetam (BRV) 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brivaracetam (BRV) 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lorazepam (LZP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lorazepam bolus is to be injected based on information from the patient leaflet/package insert. The rate of injection should not exceed 2.0 mg/min. The LZP dose will be determined according to the Investigator's clinical judgment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brivaracetam</intervention_name>
    <description>Pharmaceutical Form: Solution for infusion&#xD;
Concentration: 10 mg/ml&#xD;
Route of Administration: intravenous</description>
    <arm_group_label>Brivaracetam (BRV) 100 mg</arm_group_label>
    <arm_group_label>Brivaracetam (BRV) 200 mg</arm_group_label>
    <other_name>Briviact</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorazepam</intervention_name>
    <description>Pharmaceutical Form: Solution for injection&#xD;
Route of Administration: intravenous</description>
    <arm_group_label>Lorazepam (LZP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is male or female, 18 to 70 years of age, inclusive&#xD;
&#xD;
          -  Subject has an established diagnosis of epilepsy&#xD;
&#xD;
          -  Subject has been admitted to the institution's Epilepsy Monitoring Unit (EMU) for&#xD;
             seizure characterization or noninvasive presurgical evaluation or such admission is&#xD;
             planned within 21 days of Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has previously participated in this study and was treated with study drug.&#xD;
             Re-screen is permitted&#xD;
&#xD;
          -  Subject has participated in another study of an investigational medicinal product&#xD;
             (IMP) or a medical device within the previous 30 days of Epilepsy Monitoring Unit&#xD;
             (EMU) admission or is currently participating in another study of an IMP or a medical&#xD;
             device&#xD;
&#xD;
          -  Subject has taken brivaracetam (BRV) in the 21 days prior to EMU admission&#xD;
&#xD;
          -  History or presence of status epilepticus during the 6 months prior to EMU admission&#xD;
&#xD;
          -  Subject has a medical or psychiatric condition that in the opinion of the Investigator&#xD;
             could jeopardize or would compromise the subject's ability to participate in this&#xD;
             study&#xD;
&#xD;
          -  Subject has &gt; 2x upper limit of normal (ULN) of any of the following: alanine&#xD;
             aminotransferase, aspartate aminotransferase, alkaline phosphatase, or &gt; ULN total&#xD;
             bilirubin&#xD;
&#xD;
          -  Subject has chronic liver disease&#xD;
&#xD;
          -  Subject has hypersensitivity to BRV or any of its excipients&#xD;
&#xD;
          -  Subject has a history of alcohol or drug abuse during the 6 months prior to EMU&#xD;
             admission&#xD;
&#xD;
          -  Subject with a history of psychogenic seizures&#xD;
&#xD;
          -  Subject is a pregnant or lactating female&#xD;
&#xD;
          -  Subject has a history of a significant Adverse Event (AE) due to a benzodiazepine in&#xD;
             the opinion of the Investigator&#xD;
&#xD;
          -  Subject has respiratory failure (or is at risk for respiratory failure), untreated&#xD;
             sleep apnea, or other severe cardiorespiratory disease with New York Heart Association&#xD;
             Class III or IV functional status, or requires supplemental oxygen&#xD;
&#xD;
          -  Subject has acute narrow-angle glaucoma or myasthenia gravis&#xD;
&#xD;
          -  Subject is receiving benzodiazepine treatment (defined as an average of &gt;=4&#xD;
             administrations per week) that started less than 28 days prior to EMU admission&#xD;
&#xD;
          -  Subject has a known allergic reaction or intolerance to benzodiazepines or&#xD;
             benzodiazepine excipients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Cares</last_name>
    <role>Study Director</role>
    <affiliation>UCB (+1 844 599 2273)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ep0087 108</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 117</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 112</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 115</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 113</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 119</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 116</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 106</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 107</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 125</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 120</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 121</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 105</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ep0087 123</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033-2360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <link>
    <url>http://www.briviact.com/briviact-PI.pdf?v=1479491757</url>
    <description>Product Information</description>
  </link>
  <link>
    <url>http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>April 26, 2019</results_first_submitted>
  <results_first_submitted_qc>April 26, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 28, 2019</results_first_posted>
  <last_update_submitted>November 26, 2020</last_update_submitted>
  <last_update_submitted_qc>November 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epilepsy</keyword>
  <keyword>Brivaracetam</keyword>
  <keyword>Epilepsy Monitoring Unit</keyword>
  <keyword>Increased seizure activity</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>Lorazepam</mesh_term>
    <mesh_term>Brivaracetam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.</ipd_access_criteria>
    <ipd_url>http://www.clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03021018/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03021018/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study started to enroll patients in February 2017 and concluded in April 2018.</recruitment_details>
      <pre_assignment_details>Participant Flow refers to the Intent-to-Treat as Treated (ITT-T) Set.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lorazepam (LZP)</title>
          <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The lorazepam (LZP) dose was determined according to the Investigator's clinical judgment.</description>
        </group>
        <group group_id="P2">
          <title>Brivaracetam (BRV) 100 mg</title>
          <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period.</description>
        </group>
        <group group_id="P3">
          <title>Brivaracetam (BRV) 200 mg</title>
          <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Fall with subsequent nasal fracture</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline Characteristics refer to the Intent-to-Treat as Treated Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.</population>
      <group_list>
        <group group_id="B1">
          <title>Lorazepam (LZP)</title>
          <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The lorazepam (LZP) dose was determined according to the Investigator's clinical judgment.</description>
        </group>
        <group group_id="B2">
          <title>Brivaracetam (BRV) 100 mg</title>
          <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period.</description>
        </group>
        <group group_id="B3">
          <title>Brivaracetam (BRV) 200 mg</title>
          <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period.</description>
        </group>
        <group group_id="B4">
          <title>Total Title</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </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="41.10" spread="11.18"/>
                    <measurement group_id="B2" value="43.92" spread="12.41"/>
                    <measurement group_id="B3" value="41.59" spread="15.98"/>
                    <measurement group_id="B4" value="42.18" spread="13.06"/>
                  </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="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication</title>
        <description>This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram [EEG] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.</description>
        <time_frame>During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)</time_frame>
        <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam (LZP) (ITT-R)</title>
            <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O2">
            <title>Brivaracetam (BRV) 100 mg (ITT-R)</title>
            <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O3">
            <title>Brivaracetam (BRV) 200 mg (ITT-R)</title>
            <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication</title>
          <description>This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram [EEG] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.</description>
          <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="5.55" upper_limit="NA">Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="6.93" upper_limit="NA">Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="4.33" upper_limit="NA">Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Next Seizure (Per Clinical Observation) or Rescue Medication</title>
        <description>This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed and not necessarily confirmed via electroencephalogram [EEG]) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.</description>
        <time_frame>During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)</time_frame>
        <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam (LZP) (ITT-R)</title>
            <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O2">
            <title>Brivaracetam (BRV) 100 mg (ITT-R)</title>
            <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O3">
            <title>Brivaracetam (BRV) 200 mg (ITT-R)</title>
            <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Next Seizure (Per Clinical Observation) or Rescue Medication</title>
          <description>This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed and not necessarily confirmed via electroencephalogram [EEG]) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.</description>
          <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="5.55" upper_limit="NA">Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="6.93" upper_limit="NA">Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="4.33" upper_limit="NA">Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration</title>
        <description>This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100.</description>
        <time_frame>At 6 hours after the end of study drug administration</time_frame>
        <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam (LZP) (ITT-R)</title>
            <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O2">
            <title>Brivaracetam (BRV) 100 mg (ITT-R)</title>
            <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O3">
            <title>Brivaracetam (BRV) 200 mg (ITT-R)</title>
            <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration</title>
          <description>This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100.</description>
          <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3"/>
                    <measurement group_id="O2" value="86.7"/>
                    <measurement group_id="O3" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration</title>
        <description>This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.</description>
        <time_frame>At 8 hours after the end of study drug administration</time_frame>
        <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam (LZP) (ITT-R)</title>
            <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O2">
            <title>Brivaracetam (BRV) 100 mg (ITT-R)</title>
            <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O3">
            <title>Brivaracetam (BRV) 200 mg (ITT-R)</title>
            <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration</title>
          <description>This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.</description>
          <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3"/>
                    <measurement group_id="O2" value="80.0"/>
                    <measurement group_id="O3" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration</title>
        <description>This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.</description>
        <time_frame>At 12 hours after the end of study drug administration</time_frame>
        <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam (LZP) (ITT-R)</title>
            <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O2">
            <title>Brivaracetam (BRV) 100 mg (ITT-R)</title>
            <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O3">
            <title>Brivaracetam (BRV) 200 mg (ITT-R)</title>
            <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration</title>
          <description>This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.</description>
          <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0"/>
                    <measurement group_id="O2" value="80.0"/>
                    <measurement group_id="O3" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration</title>
        <description>This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100.</description>
        <time_frame>During the 6 hours after the end of study drug administration</time_frame>
        <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam (LZP) (ITT-R)</title>
            <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O2">
            <title>Brivaracetam (BRV) 100 mg (ITT-R)</title>
            <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O3">
            <title>Brivaracetam (BRV) 200 mg (ITT-R)</title>
            <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration</title>
          <description>This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100.</description>
          <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
          <units>percentage of participnats</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration</title>
        <description>This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.</description>
        <time_frame>During the 8 hours after the end of study drug administration</time_frame>
        <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam (LZP) (ITT-R)</title>
            <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O2">
            <title>Brivaracetam (BRV) 100 mg (ITT-R)</title>
            <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O3">
            <title>Brivaracetam (BRV) 200 mg (ITT-R)</title>
            <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration</title>
          <description>This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.</description>
          <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7"/>
                    <measurement group_id="O2" value="6.7"/>
                    <measurement group_id="O3" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration</title>
        <description>This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.</description>
        <time_frame>During the 12 hours after the end of study drug administration</time_frame>
        <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam (LZP) (ITT-R)</title>
            <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O2">
            <title>Brivaracetam (BRV) 100 mg (ITT-R)</title>
            <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
          <group group_id="O3">
            <title>Brivaracetam (BRV) 200 mg (ITT-R)</title>
            <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration</title>
          <description>This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.</description>
          <population>The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.</population>
          <units>percentage of participnats</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0"/>
                    <measurement group_id="O2" value="6.7"/>
                    <measurement group_id="O3" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lorazepam (LZP) (ITT-T)</title>
          <description>Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Treated (ITT-T) Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.</description>
        </group>
        <group group_id="E2">
          <title>Brivaracetam (BRV) 100 mg (ITT-T)</title>
          <description>Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-T Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.</description>
        </group>
        <group group_id="E3">
          <title>Brivaracetam (BRV) 200 mg (ITT-T)</title>
          <description>Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-T Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure cluster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular dissociation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </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="16"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </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</name_or_title>
      <organization>Cares</organization>
      <phone>+1844 599 ext 2273</phone>
      <email>UCBCares@ucb.com</email>
    </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/NCT03021018
org study id: EP0087
nct id: NCT03021018
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV)
      compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy
      Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication
time frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
description: This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram [EEG] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
measure: Time to Next Seizure (Per Clinical Observation) or Rescue Medication
time frame: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
description: This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed and not necessarily confirmed via electroencephalogram [EEG]) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
measure: Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration
time frame: At 6 hours after the end of study drug administration
description: This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100.
measure: Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration
time frame: At 8 hours after the end of study drug administration
description: This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.
measure: Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration
time frame: At 12 hours after the end of study drug administration
description: This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.
measure: Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration
time frame: During the 6 hours after the end of study drug administration
description: This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100.
measure: Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration
time frame: During the 8 hours after the end of study drug administration
description: This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.
measure: Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration
time frame: During the 12 hours after the end of study drug administration
description: This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.
arm group label: Brivaracetam (BRV) 100 mg
arm group type: Experimental
description: Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period
arm group label: Brivaracetam (BRV) 200 mg
arm group type: Experimental
description: Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period
arm group label: Lorazepam (LZP)
arm group type: Active Comparator
description: Lorazepam bolus is to be injected based on information from the patient leaflet/package insert. The rate of injection should not exceed 2.0 mg/min. The LZP dose will be determined according to the Investigator's clinical judgment.
intervention type: Drug
intervention name: Brivaracetam
description: Pharmaceutical Form: Solution for infusion
Concentration: 10 mg/ml
Route of Administration: intravenous
arm group label: Brivaracetam (BRV) 100 mg
arm group label: Brivaracetam (BRV) 200 mg
other name: Briviact
intervention type: Drug
intervention name: Lorazepam
description: Pharmaceutical Form: Solution for injection
Route of Administration: intravenous
arm group label: Lorazepam (LZP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: UCB Cares
role: Study Director
affiliation: UCB (+1 844 599 2273)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
country: United Kingdom
url: http://www.briviact.com/briviact-PI.pdf?v=1479491757
description: Product Information
url: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Seizures
mesh term: Lorazepam
mesh term: Brivaracetam
sharing ipd: Yes
ipd description: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
ipd access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
ipd url: http://www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 