<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/NCT01682681</url>
  </required_header>
  <id_info>
    <org_study_id>CR015865</org_study_id>
    <secondary_id>TOPMATEPY4053</secondary_id>
    <nct_id>NCT01682681</nct_id>
  </id_info>
  <brief_title>An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy</brief_title>
  <official_title>A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Korea, Ltd., Korea</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Korea, Ltd., Korea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the long-term retention rate of topiramate in&#xD;
      participants with epilepsy (seizure disorder).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (a medical research study in which participants and researchers are&#xD;
      told which treatments the participants are receiving, &quot;unblinded&quot;), single-arm, prospective&#xD;
      (study following participants forward in time), observational (a clinical study in which&#xD;
      participants identified as belonging to study groups are assessed for biomedical or health&#xD;
      outcomes) and multi-center (when more than one hospital or medical school team work on a&#xD;
      medical research study) study of topiramte in participants with epilesy. The study population&#xD;
      will be all the epilepsy participants visiting outpatient study center over a period of two&#xD;
      months. Topiramate will be administered as per Investigator's discretion for 52 weeks.&#xD;
      Participants will visit the trial site for evaluation of endpoint at Baseline, Week 12, Week&#xD;
      26, and Week 52. Efficacy will primarily be evaluated by percentage of participants which&#xD;
      will be retained to topiramate treatment uptil Week 52. Participants' safety will be&#xD;
      monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2007</start_date>
  <completion_date type="Actual">May 2009</completion_date>
  <primary_completion_date type="Actual">May 2009</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>Percentage of Participants Retained to Topiramate Treatment</measure>
    <time_frame>Week 52</time_frame>
    <description>Participants with long term retention of topiramate until 52 weeks were reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Number of participants who received concomitant AEDs along with the topiramate were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Without Seizure</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More</measure>
    <time_frame>Week 52</time_frame>
    <description>Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1234</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Topiramate</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topiramate</intervention_name>
    <description>This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.</description>
    <arm_group_label>Topiramate</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include participants with epilepsy who visit an out-patient&#xD;
        clinic for two months and have not received topiramate treatment for at least three months&#xD;
        prior to Screening.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with all type of epilepsy&#xD;
&#xD;
          -  Participants with more than 2 episodes of seizure during last 1 year&#xD;
&#xD;
          -  Participants who can comply with the visit schedule and are willing and able to&#xD;
             complete evaluation procedures specified in the protocol during the treatment period&#xD;
&#xD;
          -  Female participants with child bearing potential and who use proper contraceptive&#xD;
             methods during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have known hypersensitivity reaction or allergy to the study drug&#xD;
&#xD;
          -  Participants who have taken topiramate within the three months of study start&#xD;
&#xD;
          -  Participants who are determined not to be suitable for the clinical study&#xD;
             participation by an Investigator's discretion&#xD;
&#xD;
          -  Pregnant and nursing female participants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Korea, Ltd., Korea Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Korea, Ltd., Korea</affiliation>
  </overall_official>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>June 12, 2013</results_first_submitted>
  <results_first_submitted_qc>June 12, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 16, 2013</results_first_posted>
  <last_update_submitted>August 21, 2013</last_update_submitted>
  <last_update_submitted_qc>August 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 6, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epilepsy</keyword>
  <keyword>Topiramate</keyword>
  <keyword>Topmax</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Topiramate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Topiramate</title>
          <description>This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1234"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="1232">2 Participants were not compliant with eligibility criteria</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="902"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="332"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved to other hospital</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="174"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>tapering of topiramate</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Low compliance</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS) population included all participants who met all the eligibility criteria.</population>
      <group_list>
        <group group_id="B1">
          <title>Topiramate</title>
          <description>This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1232"/>
          </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="24.07" spread="17.10"/>
                  </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="562"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="670"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Retained to Topiramate Treatment</title>
        <description>Participants with long term retention of topiramate until 52 weeks were reported</description>
        <time_frame>Week 52</time_frame>
        <population>The full analysis set (FAS) population included all participants who met all the eligibility criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Retained to Topiramate Treatment</title>
          <description>Participants with long term retention of topiramate until 52 weeks were reported</description>
          <population>The full analysis set (FAS) population included all participants who met all the eligibility criteria.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.56" lower_limit="68.95" upper_limit="73.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)</title>
        <description>Number of participants who received concomitant AEDs along with the topiramate were reported.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>FAS population included all participants who met all the eligibility criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)</title>
          <description>Number of participants who received concomitant AEDs along with the topiramate were reported.</description>
          <population>FAS population included all participants who met all the eligibility criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy</title>
        <description>Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>FAS population included all participants who met all the eligibility criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy</title>
          <description>Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.</description>
          <population>FAS population included all participants who met all the eligibility criteria.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First Mono-therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="507" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Second Mono-therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Add-on therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Without Seizure</title>
        <description>Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>FAS population included all participants who met all the eligibility criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Without Seizure</title>
          <description>Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.</description>
          <population>FAS population included all participants who met all the eligibility criteria.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.50" lower_limit="37.76" upper_limit="43.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More</title>
        <description>Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.</description>
        <time_frame>Week 52</time_frame>
        <population>FAS population included all participants who met all the eligibility criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More</title>
          <description>Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.</description>
          <population>FAS population included all participants who met all the eligibility criteria.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.20" lower_limit="82.10" upper_limit="86.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 52</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Topiramate</title>
          <description>This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 15.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="1234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal ulcer perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hepatic neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1234"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA Version 15.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="1234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="1234"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="1234"/>
              </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>PI cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is canceled.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study design is single arm and open label, so bias could not be excluded in the subjective evaluation by Participants and Investigators.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Research Associate, Medical affairs</name_or_title>
      <organization>Janssen Korea, Location: 25F, LS , Yongsan Tower, 191, Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702, Korea</organization>
      <phone>82-2-2094-4837</phone>
    </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/NCT01682681
org study id: CR015865
secondary id: TOPMATEPY4053
nct id: NCT01682681
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the long-term retention rate of topiramate in
      participants with epilepsy (seizure disorder).
This is an open-label (a medical research study in which participants and researchers are
      told which treatments the participants are receiving, "unblinded"), single-arm, prospective
      (study following participants forward in time), observational (a clinical study in which
      participants identified as belonging to study groups are assessed for biomedical or health
      outcomes) and multi-center (when more than one hospital or medical school team work on a
      medical research study) study of topiramte in participants with epilesy. The study population
      will be all the epilepsy participants visiting outpatient study center over a period of two
      months. Topiramate will be administered as per Investigator's discretion for 52 weeks.
      Participants will visit the trial site for evaluation of endpoint at Baseline, Week 12, Week
      26, and Week 52. Efficacy will primarily be evaluated by percentage of participants which
      will be retained to topiramate treatment uptil Week 52. Participants' safety will be
      monitored throughout the study.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants Retained to Topiramate Treatment
time frame: Week 52
description: Participants with long term retention of topiramate until 52 weeks were reported
measure: Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)
time frame: Baseline up to Week 52
description: Number of participants who received concomitant AEDs along with the topiramate were reported.
measure: Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy
time frame: Baseline up to Week 52
description: Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.
measure: Percentage of Participants Without Seizure
time frame: Baseline up to Week 52
description: Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.
measure: Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More
time frame: Week 52
description: Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.
arm group label: Topiramate
intervention type: Drug
intervention name: Topiramate
description: This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
arm group label: Topiramate
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 65 Years
healthy volunteers: No
last name: Janssen Korea, Ltd., Korea Clinical Trial
role: Study Director
affiliation: Janssen Korea, Ltd., Korea
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Topiramate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study design is single arm and open label, so bias could not be excluded in the subjective evaluation by Participants and Investigators.
point of contact: 