<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/NCT03836924</url>
  </required_header>
  <id_info>
    <org_study_id>E2007-M091-508</org_study_id>
    <nct_id>NCT03836924</nct_id>
  </id_info>
  <brief_title>A Study to Assess Safety and Efficacy of Perampanel in Indian Participants as an Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Participants With Epilepsy Aged 12 Years or Older</brief_title>
  <official_title>A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety &amp; Efficacy of Perampanel in Indian Patients as An Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Patients With Epilepsy Aged 12 Years or Older</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Pharmaceuticals India Pvt. 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 this study is to assess the safety of perampanel in the treatment of partial&#xD;
      onset seizures in participants of age 12 years and older with epilepsy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period</measure>
    <time_frame>At 3 months and 6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Partial Onset Seizures</condition>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Perampanel</arm_group_label>
    <description>Participants receiving perampanel tablets, orally according to prescribing information and the treating physician's clinical judgment will be observed prospectively for up to 6 months or participant withdrawal, whichever occurs first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perampanel</intervention_name>
    <description>Perampanel tablets.</description>
    <arm_group_label>Perampanel</arm_group_label>
    <other_name>E2007</other_name>
    <other_name>Fycompa</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Indian participants with epilepsy aged 12 years or older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants prescribed perampanel for the adjunctive treatment of partial onset&#xD;
             seizures based on independent clinical judgment of treating physicians.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another study involving administration of an investigational drug or&#xD;
             device whilst participating in this observational study.&#xD;
&#xD;
          -  Hypersensitivity [allergic] to perampanel.&#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>BGS Gleneagles Global Hospitals</name>
      <address>
        <city>Bengaluru</city>
        <state>Karnataka</state>
        <zip>560060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seth G S Medical College &amp; KEM Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Clinic, Jasleen Hospital</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <zip>440012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Getwell Hospital and Research Institute</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <zip>440012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deenanath Mangeshkar Hospital and Research Centre</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifepoint Multispecialty Hospital</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411057</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizam's Institute of Medical Sciences Department of Neurology</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanjay Gandhi Post Graduate Institute of Medical Sciences</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <zip>226014</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ramakrishna mission seva pratisthan vivekananda institute of medical sciences</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700026</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sri Aurobindo Seva Kendra</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700068</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shri Ganga Ram Hospital</name>
      <address>
        <city>Delhi</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Neurology &amp; Superspeciality Hospital</name>
      <address>
        <city>Jaipur</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>E2007</keyword>
  <keyword>Fycompa</keyword>
  <keyword>Perampanel</keyword>
  <keyword>Prospective</keyword>
  <keyword>Partial onset seizures</keyword>
  <keyword>Epilepsy</keyword>
  <keyword>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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03836924
org study id: E2007-M091-508
nct id: NCT03836924
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the safety of perampanel in the treatment of partial
      onset seizures in participants of age 12 years and older with epilepsy.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: Up to 6 months
measure: Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period
time frame: Up to 6 months
measure: Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period
time frame: Up to 6 months
measure: Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period
time frame: At 3 months and 6 months
arm group label: Perampanel
description: Participants receiving perampanel tablets, orally according to prescribing information and the treating physician's clinical judgment will be observed prospectively for up to 6 months or participant withdrawal, whichever occurs first.
intervention type: Drug
intervention name: Perampanel
description: Perampanel tablets.
arm group label: Perampanel
other name: E2007
other name: Fycompa
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: India
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/.