<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/NCT03288129</url>
  </required_header>
  <id_info>
    <org_study_id>E2007-G000-410</org_study_id>
    <secondary_id>2017-001180-20</secondary_id>
    <nct_id>NCT03288129</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures</brief_title>
  <official_title>Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the retention rate of perampanel when given as monotherapy or first&#xD;
      adjunctive therapy in participants with partial-onset seizures or primary generalized tonic&#xD;
      clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier&#xD;
      than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a&#xD;
      Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">April 27, 2021</completion_date>
  <primary_completion_date type="Actual">April 27, 2021</primary_completion_date>
  <phase>Phase 4</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>Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment</measure>
    <time_frame>Month 3</time_frame>
    <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 3 months after the initiation of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment</measure>
    <time_frame>Month 6</time_frame>
    <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment</measure>
    <time_frame>Month 9</time_frame>
    <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 9 months after the initiation of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment</measure>
    <time_frame>Month 12</time_frame>
    <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period</measure>
    <time_frame>Up to 39 weeks of Maintenance Period</time_frame>
    <description>Seizure-free status was defined as no incidence of seizure during the entire maintenance period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participants does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period</measure>
    <time_frame>Up to 3 months of Maintenance Period</time_frame>
    <description>Seizure-free status was defined as no incidence of seizure at 3 months during the Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period</measure>
    <time_frame>Up to 6 months of Maintenance Period</time_frame>
    <description>Seizure-free status was defined as no incidence of seizure at 6 months during Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>Percentage of participants who received perampanel as a first adjunctive therapy and converted to perampanel monotherapy were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAE)</measure>
    <time_frame>From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)</time_frame>
    <description>A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Serious Adverse Events (SAE)</measure>
    <time_frame>From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)</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. A TEAE was defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Partial Onset Seizures</condition>
  <condition>Secondarily Generalized Seizures</condition>
  <condition>Primary Generalized Tonic-Clonic Seizures</condition>
  <arm_group>
    <arm_group_label>Perampanel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perampanel will be administered orally once daily (QD) at bedtime. At the beginning of the Titration Period, oral perampanel will start at a dose of 2 milligrams (mg) QD. Doses of perampanel will then be up titrated in increments of 2 mg at no less than 2-week intervals according to the investigator's judgment. At the 4 mg dose, the investigator will confirm whether further dose escalation is needed based on participant response and tolerability. The investigator may adjust dosing further or leave the participant at 4 mg. The maximum dose is 12 mg. During the 39-week Maintenance Period, participants will continue to receive the perampanel dose level that was administered at the end of the Titration Period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perampanel</intervention_name>
    <description>film-coated tablets</description>
    <arm_group_label>Perampanel</arm_group_label>
    <other_name>Fycompa</other_name>
    <other_name>E2007</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be male or female and no younger than 4 years of age and be able to&#xD;
             swallow perampanel tablets.&#xD;
&#xD;
          -  Participants must have a diagnosis of epilepsy with POS with or without SGS or with&#xD;
             PGTCS. Either of the following must have occurred to support an epilepsy diagnosis:&#xD;
&#xD;
               1. At least two unprovoked (or reflex) seizures occurring greater than 24 hours&#xD;
                  apart&#xD;
&#xD;
               2. One unprovoked (or reflex) seizure with Electroencephalography (EEG) evidence of&#xD;
                  seizures&#xD;
&#xD;
          -  Participants who receive perampanel as a first adjunctive therapy must currently have&#xD;
             been treated with stable doses of monotherapy with an anti-epileptic drug (AED) for 8&#xD;
             weeks prior to Visit 2 (Week 0), have not previously received adjunctive AED&#xD;
             treatment, and must, in the investigator's judgement, be in need of initial adjunctive&#xD;
             therapy after failure to control seizures with AED monotherapy, at the optimal dose&#xD;
             and duration.&#xD;
&#xD;
          -  Participants who receive perampanel as monotherapy, who were newly diagnosed&#xD;
             (treatment naïve), following the defined diagnosis of epilepsy.&#xD;
&#xD;
          -  Participants who are currently receiving monotherapy treatment may receive perampanel&#xD;
             as monotherapy if, in the investigator's judgment, the participant may benefit from a&#xD;
             change in monotherapy treatment. Participants must not have previously received&#xD;
             adjunctive AED treatment.&#xD;
&#xD;
          -  If antidepressants or antianxiety drugs are used, participants must be on a stable&#xD;
             dose regimen of these drugs during the 8 weeks before Visit 2 (Week 0).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants should not have previously received or currently be receiving perampanel.&#xD;
&#xD;
          -  Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a&#xD;
             positive beta human chorionic gonadotropin [β-hCG] or hCG test with a minimum&#xD;
             sensitivity of 25 International Units per liter [IU/L] or equivalent units of β-hCG or&#xD;
             hCG); a separate baseline assessment is required if a negative screening pregnancy&#xD;
             test was obtained more than 72 hours before the first dose of study drug.&#xD;
&#xD;
          -  Females of childbearing potential who:&#xD;
&#xD;
               -  Within 28 days before study entry, 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 or intrauterine hormone-releasing system&#xD;
&#xD;
                    -  An oral contraceptive (with additional barrier method if using contraceptive&#xD;
                       containing levonorgestrel); participant must be on a stable dose of the same&#xD;
                       oral contraceptive product for at least 28 days before dosing and throughout&#xD;
                       the study and for 28 days after study drug discontinuation&#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 study drug&#xD;
                  discontinuation For sites outside of the European Union, it is permissible that&#xD;
                  if a highly effective method of contraception is not appropriate or acceptable to&#xD;
                  the participant, then the participant must agree to use a medically acceptable&#xD;
                  method of contraception, i.e, double barrier methods of contraception such as&#xD;
                  condom plus diaphragm or cervical/vault cap with spermicide.&#xD;
&#xD;
        NOTE: All females will be considered to be of childbearing potential unless they are&#xD;
        postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age&#xD;
        group, and without other known or suspected cause) or have been sterilized surgically (i.e,&#xD;
        bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery&#xD;
        at least 1 month before dosing).&#xD;
&#xD;
          -  Presence of or previous history of Lennox-Gastaut syndrome&#xD;
&#xD;
          -  Presence of non-motor simple partial seizures only&#xD;
&#xD;
          -  A history of status epilepticus within 1 year before Screening Visit (Visit 1)&#xD;
&#xD;
          -  Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent&#xD;
             affective disorder(s) with a history of attempted suicide within 1 year before&#xD;
             Screening Visit (Visit 1)&#xD;
&#xD;
          -  Presence of a progressive central nervous system (CNS) disease, including degenerative&#xD;
             CNS diseases and progressive tumors&#xD;
&#xD;
          -  Concomitant use of barbiturates (except for seizure control indication and&#xD;
             premedication for electroencephalogram) and benzodiazepines (except for seizure&#xD;
             control indication) within 8 weeks prior to Visit 2 (Week 0)&#xD;
&#xD;
          -  Use of intermittent rescue benzodiazepines (i.e, 1 to 2 doses over a 24-hour period is&#xD;
             considered a one time rescue) 2 or more times in the 8-week period prior to Visit 2&#xD;
             (Week 0)&#xD;
&#xD;
          -  Severe renal insufficiency (defined by estimated glomerular filtration rate of &lt; 30&#xD;
             milliliters per minute [mL/min]) or participants who receive hemodialysis&#xD;
&#xD;
          -  Evidence of clinically significant disease (eg, cardiac, respiratory,&#xD;
             gastrointestinal, renal disease, hepatic disease) that in the opinion of the&#xD;
             investigator(s) could affect the participant's safety or study conduct NOTE: Stable&#xD;
             elevation of liver enzymes, alanine aminotransferase and aspartate aminotransferase&#xD;
             due to concomitant medication(s) will be allowed if they are less than 3 times the&#xD;
             upper limits of normal.&#xD;
&#xD;
          -  Hypersensitivity to perampanel or any excipients&#xD;
&#xD;
          -  Participants with rare hereditary problems of galactose intolerance, the Lapp lactase&#xD;
             deficiency or glucose-galactose malabsorption&#xD;
&#xD;
          -  Participants who are participating in other interventional clinical trial&#xD;
&#xD;
          -  Participant who are judged to have inadequate cognitive ability for participation in&#xD;
             the study (intelligence quotient &lt; 80 or investigator judgment)&#xD;
&#xD;
          -  Any suicidal ideation with intent with or without a plan, at the time of or within 6&#xD;
             months of screening, as indicated by answering &quot;Yes&quot; to questions 4 and 5 on the&#xD;
             Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)&#xD;
&#xD;
          -  Any lifetime suicidal behavior based on the C-SSRS&#xD;
&#xD;
          -  Concomitant use of any form of cannabidiol (CBD)&#xD;
&#xD;
          -  Planned brain surgery during study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barrow Neurological Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Epilepsy Program</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD Epilepsy Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92393</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health, Nemours Children's Specialty Care</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RUSH University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Atlantic Epilepsy and Sleep Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Regents of The University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48824</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Clinic of Neurology</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55442</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JFK Medical Center</name>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Regional Epilepsy Group</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNM Health Providers</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Neurology</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <results_first_submitted>April 21, 2022</results_first_submitted>
  <results_first_submitted_qc>April 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 16, 2022</results_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>monotherapy</keyword>
  <keyword>adjunctive therapy</keyword>
  <keyword>open-label</keyword>
  <keyword>multicenter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>April 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03288129/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>May 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03288129/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 14 investigative sites in the United States from 23 August 2017 to 27 April 2021.</recruitment_details>
      <pre_assignment_details>A total of 68 participants were screened, of which 54 were treated with perampanel.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Perampanel 12 mg</title>
          <description>During the Titration Period, participants received perampanel 2 milligrams per day (mg/day) and were up-titrated in no less than 2-week intervals in increments of 2 milligram (mg) up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of consent/assent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Perampanel 12 mg</title>
          <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="54"/>
          </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="38.5" spread="17.32" lower_limit="17.32"/>
                  </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="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </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 (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment</title>
        <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 3 months after the initiation of treatment.</description>
        <time_frame>Month 3</time_frame>
        <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment</title>
          <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 3 months after the initiation of treatment.</description>
          <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment</title>
        <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.</description>
        <time_frame>Month 6</time_frame>
        <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment</title>
          <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.</description>
          <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment</title>
        <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 9 months after the initiation of treatment.</description>
        <time_frame>Month 9</time_frame>
        <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment</title>
          <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 9 months after the initiation of treatment.</description>
          <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment</title>
        <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.</description>
        <time_frame>Month 12</time_frame>
        <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment</title>
          <description>The retention rate was defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.</description>
          <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period</title>
        <description>Seizure-free status was defined as no incidence of seizure during the entire maintenance period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participants does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.</description>
        <time_frame>Up to 39 weeks of Maintenance Period</time_frame>
        <population>The Full Analysis Set (FAS) included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here &quot;overall number of participants analyzed&quot; signifies participants those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period</title>
          <description>Seizure-free status was defined as no incidence of seizure during the entire maintenance period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participants does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.</description>
          <population>The Full Analysis Set (FAS) included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here &quot;overall number of participants analyzed&quot; signifies participants those who were evaluable for this outcome measure.</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="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period</title>
        <description>Seizure-free status was defined as no incidence of seizure at 3 months during the Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.</description>
        <time_frame>Up to 3 months of Maintenance Period</time_frame>
        <population>The FAS included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here &quot;overall number of participants analyzed&quot; signifies participants those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period</title>
          <description>Seizure-free status was defined as no incidence of seizure at 3 months during the Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.</description>
          <population>The FAS included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here &quot;overall number of participants analyzed&quot; signifies participants those who were evaluable for this outcome measure.</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="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period</title>
        <description>Seizure-free status was defined as no incidence of seizure at 6 months during Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.</description>
        <time_frame>Up to 6 months of Maintenance Period</time_frame>
        <population>The FAS included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here &quot;overall number of participants analyzed&quot; signifies participants those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period</title>
          <description>Seizure-free status was defined as no incidence of seizure at 6 months during Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.</description>
          <population>The FAS included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here &quot;overall number of participants analyzed&quot; signifies participants those who were evaluable for this outcome measure.</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="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy</title>
        <description>Percentage of participants who received perampanel as a first adjunctive therapy and converted to perampanel monotherapy were reported.</description>
        <time_frame>Up to 52 weeks</time_frame>
        <population>The FAS included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here &quot;overall number of participants analyzed&quot; signifies participants those who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy</title>
          <description>Percentage of participants who received perampanel as a first adjunctive therapy and converted to perampanel monotherapy were reported.</description>
          <population>The FAS included participants who received at least 1 dose of study drug and had at least 1 postdose seizure measurement. Here &quot;overall number of participants analyzed&quot; signifies participants those who were evaluable for this outcome measure.</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="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAE)</title>
        <description>A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.</description>
        <time_frame>From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)</time_frame>
        <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAE)</title>
          <description>A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.</description>
          <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Serious Adverse Events (SAE)</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. A TEAE was defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.</description>
        <time_frame>From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)</time_frame>
        <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Perampanel 12 mg</title>
            <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Serious Adverse Events (SAE)</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. A TEAE was defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.</description>
          <population>The Safety Analysis Set included participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Perampanel 12 mg</title>
          <description>During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg were allowed based on the participants response and tolerability and at the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to 39 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</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="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden unexplained death in epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.0</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="47" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="19" subjects_affected="15" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="54"/>
              </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 NOT 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 Inc.</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/NCT03288129
org study id: E2007-G000-410
secondary id: 2017-001180-20
nct id: NCT03288129
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will assess the retention rate of perampanel when given as monotherapy or first
      adjunctive therapy in participants with partial-onset seizures or primary generalized tonic
      clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier
      than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a
      Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment
time frame: Month 3
description: The retention rate was defined as the percentage of participants remaining on perampanel treatment at 3 months after the initiation of treatment.
measure: Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment
time frame: Month 6
description: The retention rate was defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.
measure: Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment
time frame: Month 9
description: The retention rate was defined as the percentage of participants remaining on perampanel treatment at 9 months after the initiation of treatment.
measure: Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment
time frame: Month 12
description: The retention rate was defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.
measure: Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period
time frame: Up to 39 weeks of Maintenance Period
description: Seizure-free status was defined as no incidence of seizure during the entire maintenance period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participants does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
measure: Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period
time frame: Up to 3 months of Maintenance Period
description: Seizure-free status was defined as no incidence of seizure at 3 months during the Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
measure: Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period
time frame: Up to 6 months of Maintenance Period
description: Seizure-free status was defined as no incidence of seizure at 6 months during Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
measure: Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy
time frame: Up to 52 weeks
description: Percentage of participants who received perampanel as a first adjunctive therapy and converted to perampanel monotherapy were reported.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE)
time frame: From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)
description: A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.
measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAE)
time frame: From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)
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. A TEAE was defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
arm group label: Perampanel
arm group type: Experimental
description: Perampanel will be administered orally once daily (QD) at bedtime. At the beginning of the Titration Period, oral perampanel will start at a dose of 2 milligrams (mg) QD. Doses of perampanel will then be up titrated in increments of 2 mg at no less than 2-week intervals according to the investigator's judgment. At the 4 mg dose, the investigator will confirm whether further dose escalation is needed based on participant response and tolerability. The investigator may adjust dosing further or leave the participant at 4 mg. The maximum dose is 12 mg. During the 39-week Maintenance Period, participants will continue to receive the perampanel dose level that was administered at the end of the Titration Period.
intervention type: Drug
intervention name: Perampanel
description: film-coated tablets
arm group label: Perampanel
other name: Fycompa
other name: E2007
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
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: 