<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/NCT03754582</url>
  </required_header>
  <id_info>
    <org_study_id>E2007-J081-240</org_study_id>
    <nct_id>NCT03754582</nct_id>
  </id_info>
  <brief_title>A Study of Intravenous Perampanel in Japanese Participants With Epilepsy</brief_title>
  <official_title>A Multicenter, Uncontrolled, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Perampanel as Substitute for Oral Tablet in Subjects With Partial Onset Seizures (Including Secondarily Generalized Seizures) or Primary Generalized Tonic-clonic Seizures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the safety and tolerability of perampanel&#xD;
      administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12&#xD;
      milligrams per day [mg/day]) as an adjunctive therapy in participants with epilepsy with&#xD;
      partial onset seizures (POS) (including secondarily generalized seizures) or primary&#xD;
      generalized tonic-clonic (PGTC) seizures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">December 10, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)</time_frame>
    <description>A SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, any new disease or exacerbation of an existing disease, any deterioration in nonprotocol-required measurements of a laboratory value or other clinical test that resulted in symptoms, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase</measure>
    <time_frame>Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after last dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Vital Sign Values During Treatment and Follow-up Phase</measure>
    <time_frame>Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Body Weight During Treatment and Follow-up Phase</measure>
    <time_frame>Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Markedly Abnormal Electrocardiogram (ECG) Value During Treatment and Follow-up Phase</measure>
    <time_frame>Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after the last dose)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Seizure Frequency Per Day in Pretreatment Phase, Treatment Phase and Follow-up Phase</measure>
    <time_frame>Up to 39 days (Pretreatment Phase: up to 28 days; Treatment Phase: up to 4 days; Follow-up Phase: up to 7 days after the last dose)</time_frame>
    <description>Seizure frequency was based on number of seizures per day, calculated as the number of seizures over the entire time interval divided by the number of days in the interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel</measure>
    <time_frame>Pretreatment Phase-Day -1: Pre-dose, 0.5 hours, 1 hours and 1.5 hours post-dose; Treatment Phase-Day 1, Day 2, Day 3 and Day 4: Pre-dose and 0.5 hours after start of intravenous infusions</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Epilepsy</condition>
  <condition>Seizures</condition>
  <arm_group>
    <arm_group_label>Perampanel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures will receive perampanel 8 to 12 milligram (mg), tablets, orally, once daily for 28 days (Day -28 to Day -1) in Pretreatment Phase and followed by 8 to 12 mg dose of perampanel as intravenous infusion for 30 minutes, once daily from Day 1 to Day 4 in Treatment Phase, and then again 8 to 12 mg, tablets, orally, once daily from Day 5 to Day 11 in Follow-up Phase as an adjunctive therapy, along with 1 to a maximum of 3 marketed concomitant antiepileptic drugs (AEDs).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perampanel</intervention_name>
    <description>Oral tablets.</description>
    <arm_group_label>Perampanel</arm_group_label>
    <other_name>E2007</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perampanel</intervention_name>
    <description>Intravenous infusion.</description>
    <arm_group_label>Perampanel</arm_group_label>
    <other_name>E2007</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A diagnosis of epilepsy with POS (including secondarily generalized seizures) or PGTC&#xD;
             seizures according to the International League Against Epilepsy (ILAE) Classification&#xD;
             of Epileptic Seizures (1981).&#xD;
&#xD;
          2. Receiving a stable dose regimen of oral perampanel.&#xD;
&#xD;
          3. Receiving a concomitant stable dose regimen of marketed AEDs. No change of dosing&#xD;
             regimen for concomitant AEDs is planned during the intravenous Treatment and Follow-up&#xD;
             Phases.&#xD;
&#xD;
          4. Considered reliable and willing to be available for the study period by the&#xD;
             investigator, and are able to record seizures and report AEs by themselves or have a&#xD;
             caregiver who can record seizures and report AEs for them.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of drug or alcohol dependency or abuse.&#xD;
&#xD;
          2. A history of status epilepticus.&#xD;
&#xD;
          3. Unsuitable for venipuncture and intravenous administration.&#xD;
&#xD;
          4. Requires medical intervention due to safety issues related to concomitant&#xD;
             administration of AEDs.&#xD;
&#xD;
          5. A history of suicidal ideation/attempt.&#xD;
&#xD;
          6. Clinical symptoms or imaging suggest progressive central nervous system (CNS)&#xD;
             abnormality, disorder, or brain tumor.&#xD;
&#xD;
          7. Current evidence of clinically significant disease (example, cardiac, respiratory,&#xD;
             gastrointestinal, renal disease) that in the opinion of the investigators could affect&#xD;
             the participant's safety, interfere with the study assessments or need prohibited&#xD;
             medications as specified in the study protocol.&#xD;
&#xD;
          8. Clinically significant abnormal laboratory values.&#xD;
&#xD;
          9. Females of childbearing potential who:&#xD;
&#xD;
               -  In the Pretreatment Phase, are breastfeeding or pregnant (as documented by a&#xD;
                  positive beta-human chorionic gonadotropin [β-hCG] test).&#xD;
&#xD;
               -  Within 28 days before Visit 1, did not use a highly effective method of&#xD;
                  contraception, which includes any of the following:&#xD;
&#xD;
                    -  total abstinence (if it is their preferred and usual lifestyle).&#xD;
&#xD;
                    -  an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).&#xD;
&#xD;
                    -  a contraceptive implant.&#xD;
&#xD;
                    -  an oral contraceptive (with additional barrier method). (Participant must be&#xD;
                       on a stable dose of the same oral contraceptive product for at least 28 days&#xD;
                       before Day 1 of the Treatment Phase and throughout the entire study period,&#xD;
                       and for 28 days after the last dose of study drug).&#xD;
&#xD;
                    -  have a vasectomized partner with confirmed azoospermia.&#xD;
&#xD;
                    -  Do not agree to use a highly effective method of contraception (as described&#xD;
                       above) throughout the entire study period and for 28 days after the last&#xD;
                       dose of study drug.&#xD;
&#xD;
         10. Participation in a study involving administration of an investigational drug or device&#xD;
             within 28 days before Visit 1, or within approximately 5 half-lives of the previous&#xD;
             investigational compound, whichever is longer.&#xD;
&#xD;
         11. A prolonged QT interval corrected using Fridericia's formula (QTcF) interval (greater&#xD;
             than [&gt;] 450 millisecond [ms]) as demonstrated by a repeated ECG.&#xD;
&#xD;
         12. A vagus nerve stimulation (VNS) implanted.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eisai trial site 5</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 12</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 9</name>
      <address>
        <city>Omura</city>
        <state>Nagasaki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 7</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 2</name>
      <address>
        <city>Asaka</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 13</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 8</name>
      <address>
        <city>Kodaira</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 10</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 6</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 1</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 11</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 3</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai trial site 4</name>
      <address>
        <city>Yamagata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <results_first_submitted>December 9, 2020</results_first_submitted>
  <results_first_submitted_qc>December 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 5, 2021</results_first_posted>
  <last_update_submitted>December 9, 2020</last_update_submitted>
  <last_update_submitted_qc>December 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Partial Onset Seizures</keyword>
  <keyword>Secondarily Generalized Seizures</keyword>
  <keyword>Primary Generalized Tonic-Clonic Seizures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Seizures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.</ipd_description>
  </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>October 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03754582/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>February 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03754582/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in this study at 13 investigative sites in Japan from 27 November 2018 to 10 December 2019.</recruitment_details>
      <pre_assignment_details>A total of 27 participants were consented, of which 6 were screen failures and 21 were enrolled and received the study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day</title>
          <description>Participants with partial onset-seizures (POS) with or without secondarily generalized seizures or primary generalized tonic clonic (PGTC) seizures received perampanel 8 milligram (mg) up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant antiepileptic drugs (AEDs). Eligible participants who completed Pretreatment Phase entered in Treatment Phase.</description>
        </group>
        <group group_id="P2">
          <title>Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day</title>
          <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.</description>
        </group>
        <group group_id="P3">
          <title>Follow-up Phase: Oral Perampanel 8 to 12 mg/Day</title>
          <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pretreatment Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <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="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="21">1 participant who discontinued in Treatment Phase was assessed at Follow-up Visit.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Perampanel 8 to 12 mg/Day</title>
          <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received maintenance dose of perampanel 8 to 12 mg, tablets, orally, once daily for 28 days (Day -28 to Day -1) in Pretreatment Phase followed by 8 to 12 mg maintenance dose of perampanel equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily from Day 1 to Day 4 in Treatment Phase, and then 8 to 12 mg maintenance dose of perampanel, tablets, orally, once daily from Day 5 to Day 11 (Follow-up Visit) in Follow-up Phase as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </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="40.7" spread="12.76"/>
                  </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="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>
              <title>Japanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs)</title>
        <description>A SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect.</description>
        <time_frame>Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.</description>
          </group>
          <group group_id="O3">
            <title>Follow-up Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs)</title>
          <description>A SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect.</description>
          <population>All participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, any new disease or exacerbation of an existing disease, any deterioration in nonprotocol-required measurements of a laboratory value or other clinical test that resulted in symptoms, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not.</description>
        <time_frame>Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.</description>
          </group>
          <group group_id="O3">
            <title>Follow-up Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, any new disease or exacerbation of an existing disease, any deterioration in nonprotocol-required measurements of a laboratory value or other clinical test that resulted in symptoms, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not.</description>
          <population>All participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase</title>
        <time_frame>Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after last dose)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.</description>
          </group>
          <group group_id="O2">
            <title>Follow-up Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase</title>
          <population>All participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Triglycerides: Markedly Abnormal High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate: Markedly Abnormal High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Vital Sign Values During Treatment and Follow-up Phase</title>
        <time_frame>Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.</description>
          </group>
          <group group_id="O2">
            <title>Follow-up Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Vital Sign Values During Treatment and Follow-up Phase</title>
          <population>All participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Body Weight During Treatment and Follow-up Phase</title>
        <time_frame>Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.</description>
          </group>
          <group group_id="O2">
            <title>Follow-up Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Body Weight During Treatment and Follow-up Phase</title>
          <population>All participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Markedly Abnormal Electrocardiogram (ECG) Value During Treatment and Follow-up Phase</title>
        <time_frame>Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after the last dose)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.</description>
          </group>
          <group group_id="O2">
            <title>Follow-up Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Markedly Abnormal Electrocardiogram (ECG) Value During Treatment and Follow-up Phase</title>
          <population>All participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Seizure Frequency Per Day in Pretreatment Phase, Treatment Phase and Follow-up Phase</title>
        <description>Seizure frequency was based on number of seizures per day, calculated as the number of seizures over the entire time interval divided by the number of days in the interval.</description>
        <time_frame>Up to 39 days (Pretreatment Phase: up to 28 days; Treatment Phase: up to 4 days; Follow-up Phase: up to 7 days after the last dose)</time_frame>
        <population>All participants who received at least 1 dose of study drug. Here &quot;Number Analyzed&quot; signifies participants who were evaluable for this outcome measure for POS and PGTC seizures.</population>
        <group_list>
          <group group_id="O1">
            <title>Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.</description>
          </group>
          <group group_id="O2">
            <title>Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.</description>
          </group>
          <group group_id="O3">
            <title>Follow-up Phase: Oral Perampanel 8 to 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Seizure Frequency Per Day in Pretreatment Phase, Treatment Phase and Follow-up Phase</title>
          <description>Seizure frequency was based on number of seizures per day, calculated as the number of seizures over the entire time interval divided by the number of days in the interval.</description>
          <population>All participants who received at least 1 dose of study drug. Here &quot;Number Analyzed&quot; signifies participants who were evaluable for this outcome measure for POS and PGTC seizures.</population>
          <units>seizures per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="0.578"/>
                    <measurement group_id="O2" value="0.39" spread="0.838"/>
                    <measurement group_id="O3" value="0.24" spread="0.287"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PGTC Seizures</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="NA">Standard Deviation could not be estimated as only 1 participant was available for analysis.</measurement>
                    <measurement group_id="O2" value="0" spread="NA">Standard Deviation could not be estimated as only 1 participant was available for analysis.</measurement>
                    <measurement group_id="O3" value="0" spread="NA">Standard Deviation could not be estimated as only 1 participant was available for analysis.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel</title>
        <time_frame>Pretreatment Phase-Day -1: Pre-dose, 0.5 hours, 1 hours and 1.5 hours post-dose; Treatment Phase-Day 1, Day 2, Day 3 and Day 4: Pre-dose and 0.5 hours after start of intravenous infusions</time_frame>
        <population>All participants who received at least 1 dose of study drug. Here &quot;Number Analyzed&quot; signifies participants who were evaluable for this outcome measure at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Pretreatment Phase: Oral Perampanel 8 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.</description>
          </group>
          <group group_id="O2">
            <title>Pretreatment Phase: Oral Perampanel 10 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 10 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.</description>
          </group>
          <group group_id="O3">
            <title>Pretreatment Phase: Oral Perampanel 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.</description>
          </group>
          <group group_id="O4">
            <title>Treatment Phase: Intravenous Perampanel 8 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
          <group group_id="O5">
            <title>Treatment Phase: Intravenous Perampanel 10 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 10 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
          <group group_id="O6">
            <title>Treatment Phase: Intravenous Perampanel 12 mg/Day</title>
            <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel</title>
          <population>All participants who received at least 1 dose of study drug. Here &quot;Number Analyzed&quot; signifies participants who were evaluable for this outcome measure at given time points.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day -1: Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="430" spread="336"/>
                    <measurement group_id="O2" value="352" spread="172"/>
                    <measurement group_id="O3" value="556" spread="255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day -1: 0.5 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="464" spread="369"/>
                    <measurement group_id="O2" value="435" spread="216"/>
                    <measurement group_id="O3" value="608" spread="271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day -1: 1 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="538" spread="385"/>
                    <measurement group_id="O2" value="499" spread="226"/>
                    <measurement group_id="O3" value="664" spread="282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day -1: 1.5 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="555" spread="356"/>
                    <measurement group_id="O2" value="521" spread="227"/>
                    <measurement group_id="O3" value="658" spread="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="402" spread="304"/>
                    <measurement group_id="O5" value="316" spread="156"/>
                    <measurement group_id="O6" value="554" spread="234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: 0.5 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="609" spread="303"/>
                    <measurement group_id="O5" value="591" spread="172"/>
                    <measurement group_id="O6" value="837" spread="282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2: Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="382" spread="298"/>
                    <measurement group_id="O5" value="297" spread="170"/>
                    <measurement group_id="O6" value="540" spread="232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2: 0.5 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="614" spread="315"/>
                    <measurement group_id="O5" value="520" spread="184"/>
                    <measurement group_id="O6" value="760" spread="261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="372" spread="277"/>
                    <measurement group_id="O5" value="296" spread="175"/>
                    <measurement group_id="O6" value="560" spread="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3: 0.5 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="557" spread="301"/>
                    <measurement group_id="O5" value="547" spread="169"/>
                    <measurement group_id="O6" value="815" spread="276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4: Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="394" spread="307"/>
                    <measurement group_id="O5" value="297" spread="184"/>
                    <measurement group_id="O6" value="552" spread="259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4: 0.5 hour post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="554" spread="300"/>
                    <measurement group_id="O5" value="541" spread="209"/>
                    <measurement group_id="O6" value="841" spread="312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after the last dose)</time_frame>
      <desc>All participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pretreatment Phase: Oral Perampanel 8 to 12 mg/Day</title>
          <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily for 28 days (Day -28 to Day -1) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Pretreatment Phase entered in Treatment Phase.</description>
        </group>
        <group group_id="E2">
          <title>Treatment Phase: Intravenous Perampanel 8 to 12 mg/Day</title>
          <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures were hospitalized and received perampanel 8 mg up to 12 mg (stable-dosage) equivalent to the oral dose, as intravenous infusion for 30 minutes, once daily on Day 1 to Day 4 as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs. Eligible participants who completed Treatment Phase entered Follow-up Phase.</description>
        </group>
        <group group_id="E3">
          <title>Follow-up Phase: Oral Perampanel 8 to 12 mg/Day</title>
          <description>Participants with POS with or without secondarily generalized seizures or PGTC seizures received perampanel 8 mg up to 12 mg (stable-dosage), tablets, orally, once daily on Day 5 to Day 11 (Follow-up Visit) as an adjunctive therapy along with 1 to a maximum of 3 marketed concomitant AEDs.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.1)</default_vocab>
        <default_assessment>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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (22.1)</default_vocab>
        <default_assessment>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="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Eisai Medical Information</name_or_title>
      <organization>Eisai Co., Ltd.</organization>
      <phone>+1-888-274-2378</phone>
      <email>esi_medinfo@eisai.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/NCT03754582
org study id: E2007-J081-240
nct id: NCT03754582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the safety and tolerability of perampanel
      administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12
      milligrams per day [mg/day]) as an adjunctive therapy in participants with epilepsy with
      partial onset seizures (POS) (including secondarily generalized seizures) or primary
      generalized tonic-clonic (PGTC) seizures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Serious Adverse Events (SAEs)
time frame: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)
description: A SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect.
measure: Number of Participants With Adverse Events (AEs)
time frame: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)
description: An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, any new disease or exacerbation of an existing disease, any deterioration in nonprotocol-required measurements of a laboratory value or other clinical test that resulted in symptoms, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not.
measure: Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase
time frame: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after last dose)
measure: Number of Participants With Abnormal Vital Sign Values During Treatment and Follow-up Phase
time frame: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
measure: Number of Participants With Abnormal Body Weight During Treatment and Follow-up Phase
time frame: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
measure: Number of Participants With Clinically Significant Markedly Abnormal Electrocardiogram (ECG) Value During Treatment and Follow-up Phase
time frame: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after the last dose)
measure: Mean Seizure Frequency Per Day in Pretreatment Phase, Treatment Phase and Follow-up Phase
time frame: Up to 39 days (Pretreatment Phase: up to 28 days; Treatment Phase: up to 4 days; Follow-up Phase: up to 7 days after the last dose)
description: Seizure frequency was based on number of seizures per day, calculated as the number of seizures over the entire time interval divided by the number of days in the interval.
measure: Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
time frame: Pretreatment Phase-Day -1: Pre-dose, 0.5 hours, 1 hours and 1.5 hours post-dose; Treatment Phase-Day 1, Day 2, Day 3 and Day 4: Pre-dose and 0.5 hours after start of intravenous infusions
arm group label: Perampanel
arm group type: Experimental
description: Participants with POS with or without secondarily generalized seizures or PGTC seizures will receive perampanel 8 to 12 milligram (mg), tablets, orally, once daily for 28 days (Day -28 to Day -1) in Pretreatment Phase and followed by 8 to 12 mg dose of perampanel as intravenous infusion for 30 minutes, once daily from Day 1 to Day 4 in Treatment Phase, and then again 8 to 12 mg, tablets, orally, once daily from Day 5 to Day 11 in Follow-up Phase as an adjunctive therapy, along with 1 to a maximum of 3 marketed concomitant antiepileptic drugs (AEDs).
intervention type: Drug
intervention name: Perampanel
description: Oral tablets.
arm group label: Perampanel
other name: E2007
intervention type: Drug
intervention name: Perampanel
description: Intravenous infusion.
arm group label: Perampanel
other name: E2007
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Seizures
sharing ipd: Yes
ipd description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 