<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/NCT02239380</url>
  </required_header>
  <id_info>
    <org_study_id>B3541002</org_study_id>
    <secondary_id>2017-000125-13</secondary_id>
    <nct_id>NCT02239380</nct_id>
  </id_info>
  <brief_title>Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan</brief_title>
  <official_title>A Multi-center, Open-label, Non-controlled Study To Evaluate The Efficacy And Safety Of Lorazepam Intravenously Administered In Subjects With Status Epilepticus Or Repetitive Status Epilepticus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the efficacy, safety and pharmacokinetics of&#xD;
      Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug</measure>
    <time_frame>30 minutes post Dose 1</time_frame>
    <description>Participants with clinical benefit were defined as participants whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug</measure>
    <time_frame>30 minutes post Dose 1 or 2</time_frame>
    <description>Percentage of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug</measure>
    <time_frame>12 hour post Dose 1; 12 hour post Dose 1 or 2</time_frame>
    <description>Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug</measure>
    <time_frame>24 hour post Dose 1; 24 hour post Dose 1 or 2</time_frame>
    <description>Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug</measure>
    <time_frame>10 minutes post Dose 1; 10 minutes post Dose 1 or 2</time_frame>
    <description>Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug</measure>
    <time_frame>24 hour post Dose 1; 24 hour post Dose 1 or 2</time_frame>
    <description>Time to relapse (in minutes) was defined as duration from the time of study drug administration to the time of relapse, as determined by investigator. Participants whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 7 days after last dose of study drug administration (up to 12 days)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Status Epilepticus</condition>
  <arm_group>
    <arm_group_label>Lorazepam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lorazepam intravenous formulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorazepam</intervention_name>
    <description>intravenous administration. Dosage for adult subjects (16 years aged and over): 4 mg Dosage for pediatric subjects (3 months to &lt; 16 years): 0.05 mg/kg (but not exceeding 4 mg) Frequency: Intravenous administration of lorazepam. Subjects whose seizure does not stop or recurs within 10 minutes after the initial dose may receive the same amount of lorazepam injection no earlier than 10 minutes following the initial dose.&#xD;
Also, subjects whose seizure stops within 10 minutes after the initial dose, but recurs thereafter (within 12 hours) may receive the same amount of lorazepam injection; a total of 2 doses will be permitted in this study.</description>
    <arm_group_label>Lorazepam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with status epilepticus or repetitive status epilepticus / cluster seizure&#xD;
             who have seizures that can be evaluated by investigator's visual observations based on&#xD;
             motor symptoms or who have seizures that can be evaluated by EEG.&#xD;
&#xD;
          -  Subjects with status epilepticus accompanied by generalized seizure, partial seizure&#xD;
             or secondarily generalized seizure lasting 5 minutes or longer&#xD;
&#xD;
          -  Subjects with repetitive status epilepticus / cluster seizure accompanied by not less&#xD;
             than 3 consecutive episodes of generalized seizure, partial seizure or secondarily&#xD;
             generalized seizure in 1 hour.&#xD;
&#xD;
          -  Subjects not younger than 3 months (either gender is eligible for the study)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known or suspected recurrent seizures due to illegal drug or alcohol&#xD;
             withdrawal&#xD;
&#xD;
          -  Subjects with known history of hypersensitivity to lorazepam or benzodiazepine&#xD;
&#xD;
          -  Subjects with a known history of benzodiazepine abuse.&#xD;
&#xD;
          -  Subjects currently receiving lorazepam&#xD;
&#xD;
          -  Subjects with angle-closure glaucoma&#xD;
&#xD;
          -  Subjects with myasthenia gravis&#xD;
&#xD;
          -  Subjects with either of aspartate transaminase, alanine transaminase, total bilirubin,&#xD;
             blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of&#xD;
             normal of the institutional reference value (if the data is available)&#xD;
&#xD;
          -  Subjects with white blood cell count less than 3000/mm3 or neutrophil count less than&#xD;
             1500/mm3 at screening visit (if the data is available)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aichi Children's Health and Medical Center</name>
      <address>
        <city>Obu-shi</city>
        <state>Aichi</state>
        <zip>474-8710</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Fukuoka-Higashi Medical Center</name>
      <address>
        <city>Koga</city>
        <state>Fukuoka</state>
        <zip>811-3195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Medical Center for Child Health and Rehabilitation</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>006-0041</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nakamura Memorial Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8570</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Hokkaido Medical Center</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>063-0005</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Prefectural Kobe Children's Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Nagasaki Medical Center</name>
      <address>
        <city>Ohmura</city>
        <state>Nagasaki</state>
        <zip>856-8562</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Nishi-Niigata Central Hospital / Pediatrics</name>
      <address>
        <city>Niigata-shi</city>
        <state>Niigata</state>
        <zip>950-2085</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital / Child Neurology</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Medical Center and Research Institute for Maternal and Child Health</name>
      <address>
        <city>Izumi</city>
        <state>Osaka</state>
        <zip>594-1101</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City General Hospital Pediatric Neurology</name>
      <address>
        <city>Miyakojima-ku</city>
        <state>Osaka</state>
        <zip>534-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Shizuoka Institute of Epilepsy and Neurological Disorders</name>
      <address>
        <city>Shizuoka-city</city>
        <state>Shizuoka</state>
        <zip>420-8688</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center of Neurology and Psychiatry</name>
      <address>
        <city>Kodaira</city>
        <state>Tokyo</state>
        <zip>187-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamanashi Prefectural Central Hospital</name>
      <address>
        <city>Kofu</city>
        <state>Yamanashi</state>
        <zip>400-8506</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka Children's Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>813-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka Sanno Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gifu Prefectural General Medical Center</name>
      <address>
        <city>Gifu</city>
        <zip>500-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Children's Medical Center</name>
      <address>
        <city>Saitama</city>
        <zip>339-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3541002&amp;StudyName=Lorazepam%20for%20the%20Treatment%20of%20Status%20Epilepticus%20or%20Repetitive%20Status%20Epilepticus%20in%20Japan</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <results_first_submitted>December 18, 2017</results_first_submitted>
  <results_first_submitted_qc>October 11, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2019</results_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lorazepam</keyword>
  <keyword>Status Epilepticus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Status Epilepticus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lorazepam</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lorazepam</title>
          <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set included all participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Lorazepam</title>
          <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="14.0" spread="12.9"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug</title>
        <description>Participants with clinical benefit were defined as participants whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1).</description>
        <time_frame>30 minutes post Dose 1</time_frame>
        <population>Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluded those participants whose status epilepticus (SE) or repetitive SE/cluster seizure was determined on the electroencephalography (EEG).</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam</title>
            <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug</title>
          <description>Participants with clinical benefit were defined as participants whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1).</description>
          <population>Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluded those participants whose status epilepticus (SE) or repetitive SE/cluster seizure was determined on the electroencephalography (EEG).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.0" lower_limit="27.8" upper_limit="68.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug</title>
        <description>Percentage of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this outcome measure.</description>
        <time_frame>30 minutes post Dose 1 or 2</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam</title>
            <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug</title>
          <description>Percentage of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this outcome measure.</description>
          <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.0" lower_limit="42.5" upper_limit="82.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug</title>
        <description>Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this outcome measure.</description>
        <time_frame>12 hour post Dose 1; 12 hour post Dose 1 or 2</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam</title>
            <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug</title>
          <description>Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this outcome measure.</description>
          <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG.</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="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Dose 1 or 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug</title>
        <description>Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this outcome measure.</description>
        <time_frame>24 hour post Dose 1; 24 hour post Dose 1 or 2</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam</title>
            <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug</title>
          <description>Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this outcome measure.</description>
          <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG.</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="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Dose 1 or 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug</title>
        <description>Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications.</description>
        <time_frame>10 minutes post Dose 1; 10 minutes post Dose 1 or 2</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, 'n' signifies those participants who were evaluable for specific category.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam</title>
            <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug</title>
          <description>Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications.</description>
          <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, 'n' signifies those participants who were evaluable for specific category.</population>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Dose 1 or 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug</title>
        <description>Time to relapse (in minutes) was defined as duration from the time of study drug administration to the time of relapse, as determined by investigator. Participants whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this outcome measure.</description>
        <time_frame>24 hour post Dose 1; 24 hour post Dose 1 or 2</time_frame>
        <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam</title>
            <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug</title>
          <description>Time to relapse (in minutes) was defined as duration from the time of study drug administration to the time of relapse, as determined by investigator. Participants whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this outcome measure.</description>
          <population>FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.</population>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.0" lower_limit="11" upper_limit="879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Dose 1 or 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.0" lower_limit="23" upper_limit="1246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.</description>
        <time_frame>Baseline up to 7 days after last dose of study drug administration (up to 12 days)</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Lorazepam</title>
            <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 7 days after last dose of study drug administration (up to 12 days)</time_frame>
      <desc>The same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one event and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Lorazepam</title>
          <description>Participants aged between 3 months to below 16 years received single intravenous dose (Dose 1) of 0.05 milligram per kilogram (mg/kg) of Lorazepam (up to a maximum dose of 4 mg) on Day 1. Participants aged above 16 years received single intravenous dose of 4 mg of Lorazepam. Participants whose seizures continued or recurred within 10 minutes following the initial dose, an additional dose (Dose 2) of 4 mg (for participants above 16 years of age) or 0.05 mg/kg dose (for participants between 3 months to below 16 years of age) was administered accordingly. Participants were followed up to 7 days after last dose of study drug administration.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 19.1</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="12" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>001-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT02239380
org study id: B3541002
secondary id: 2017-000125-13
nct id: NCT02239380
lead sponsor: 
has dmc: No
The purpose of this study is to determine the efficacy, safety and pharmacokinetics of
      Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug
time frame: 30 minutes post Dose 1
description: Participants with clinical benefit were defined as participants whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1).
measure: Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug
time frame: 30 minutes post Dose 1 or 2
description: Percentage of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this outcome measure.
measure: Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug
time frame: 12 hour post Dose 1; 12 hour post Dose 1 or 2
description: Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this outcome measure.
measure: Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug
time frame: 24 hour post Dose 1; 24 hour post Dose 1 or 2
description: Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this outcome measure.
measure: Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug
time frame: 10 minutes post Dose 1; 10 minutes post Dose 1 or 2
description: Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications.
measure: Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug
time frame: 24 hour post Dose 1; 24 hour post Dose 1 or 2
description: Time to relapse (in minutes) was defined as duration from the time of study drug administration to the time of relapse, as determined by investigator. Participants whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this outcome measure.
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 7 days after last dose of study drug administration (up to 12 days)
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.
arm group label: Lorazepam
arm group type: Experimental
description: Lorazepam intravenous formulation
intervention type: Drug
intervention name: Lorazepam
description: intravenous administration. Dosage for adult subjects (16 years aged and over): 4 mg Dosage for pediatric subjects (3 months to < 16 years): 0.05 mg/kg (but not exceeding 4 mg) Frequency: Intravenous administration of lorazepam. Subjects whose seizure does not stop or recurs within 10 minutes after the initial dose may receive the same amount of lorazepam injection no earlier than 10 minutes following the initial dose.
Also, subjects whose seizure stops within 10 minutes after the initial dose, but recurs thereafter (within 12 hours) may receive the same amount of lorazepam injection; a total of 2 doses will be permitted in this study.
arm group label: Lorazepam
criteria: 
gender: All
minimum age: 3 Months
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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facility: 
country: Japan
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3541002&StudyName=Lorazepam%20for%20the%20Treatment%20of%20Status%20Epilepticus%20or%20Repetitive%20Status%20Epilepticus%20in%20Japan
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Status Epilepticus
mesh term: Lorazepam
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 