<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/NCT01689649</url>
  </required_header>
  <id_info>
    <org_study_id>CR017830</org_study_id>
    <secondary_id>TOPMATEPY4049</secondary_id>
    <secondary_id>TOP-VN -0107</secondary_id>
    <nct_id>NCT01689649</nct_id>
  </id_info>
  <brief_title>A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy</brief_title>
  <official_title>Open Flexible Dose Optimisation Trial Assessing Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy Who Are Treatment Naive or Have Failed One Anti-Epileptic Drug Treatment in Monotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Pte Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Pte Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this dose optimization study is to assess tolerability and efficacy of&#xD;
      topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive&#xD;
      or have failed one anti-epileptic drug (AED) treatment in monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label (all people know the identity of the intervention), dose optimization&#xD;
      trial to assess the tolerability and efficacy of topiramate as monotherapy in recently&#xD;
      (within 5 years) diagnosed patients with epilepsy. Treatment naive patients (patients who&#xD;
      have never received the treatment before) and patients who failed on their first AED in&#xD;
      monotherapy are allowed. Failure is defined as a lack of efficacy and/or tolerability of that&#xD;
      AED and the reason for failure is recorded by the physician. A lack of efficacy is&#xD;
      characterized when the patient has been treated with AED at target dose but the patient still&#xD;
      has seizure. Topiramate will first be titrated up to an initial target dose that will be&#xD;
      reached after 4-6 weeks. Further dose titration is guided by the clinical response of the&#xD;
      individual patient, but the dose may not exceed a maximum of 400mg/day [9mg/kg/day for&#xD;
      children]. If the patient uses an AED at entry, the AED will be fully tapered off over a&#xD;
      period of 3 weeks, starting at the beginning of week 2, in order to have all patients on&#xD;
      topiramate monotherapy at visit 3. Tapering the AED off may, however, extend this 3-week&#xD;
      period if clinically indicated. Visits will be performed at baseline and after 2, 4, 8, 12,&#xD;
      16 weeks. The total duration for each patient in the study will be 4 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2008</start_date>
  <completion_date type="Actual">January 2010</completion_date>
  <primary_completion_date type="Actual">January 2010</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 Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment</measure>
    <time_frame>Month 1, Month 3 and Month 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment</measure>
    <time_frame>Month 1, Month 3 and Month 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Seizure Free Participants During the Last 4 Months of Treatment</measure>
    <time_frame>Month 1, Month 3 and Month 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks</measure>
    <time_frame>Month 1, Month 3 and Month 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks</measure>
    <time_frame>Month 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Clinical Assessment Before and After Treatment</measure>
    <time_frame>Baseline (Day 0) and Month 4</time_frame>
    <description>The general clinical assessment is measured by clinical global impression scale. The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment</measure>
    <time_frame>Month 4</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Topiramate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For children: Children will start on topiramate with a dosage of 0.5mg/kg in the evening, followed by 0.5mg/kg/day weekly increments until an initial target dose of 3mg/kg/day is reached. The total daily topiramate dose for children may, not exceed 9mg/kg/day. For adult patients: Adult patients start on topiramate with a dosage of 25mg/day in the evening, followed by weekly increments of 25 mg/day until an initial target dose of 100mg/day is reached. The dose of topiramate may be increased to the optimal dose with weekly increments of 0.5mg/kg/day and of 25 mg/day for children and adults, respectively at the discretion of the investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topiramate</intervention_name>
    <description>The patients will receive topiramate tablet twice daily orally up to 16 weeks.</description>
    <arm_group_label>Topiramate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has been diagnosed with epilepsy within the past 5 years with Primary Generalized&#xD;
             Tonic-Clonic (PGTC) seizures as well as partial onset seizures with or without&#xD;
             secondary generalization&#xD;
&#xD;
          -  Therapy naive, or being treated with their first anti-epileptic drug (AED) in&#xD;
             monotherapy that fails in efficacy, tolerability, or both, and not in need of a&#xD;
             combination AED therapy&#xD;
&#xD;
          -  Informed Assent in children at least 7 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have pseudoseizures or the treatable cause of the seizures (eg, metabolic disorder,&#xD;
             toxic exposure, active infection or neoplasia)&#xD;
&#xD;
          -  Has any clinically relevant progressive or serious illness (eg, liver or renal&#xD;
             insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine,&#xD;
             neurological, psychiatric, or metabolic disturbance)&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Has a history or suspicion of alcohol or drug abuse&#xD;
&#xD;
          -  Must have on current treatment with furosemide, hydrochlorothiazide, monoamine oxidase&#xD;
             inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen-Cilag VIETNAM Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag VIETNAM</affiliation>
  </overall_official>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>October 22, 2012</results_first_submitted>
  <results_first_submitted_qc>October 22, 2012</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 21, 2012</results_first_posted>
  <last_update_submitted>April 26, 2013</last_update_submitted>
  <last_update_submitted_qc>April 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epilepsy</keyword>
  <keyword>Seizures</keyword>
  <keyword>Topiramate</keyword>
  <keyword>Anti-epileptic drug</keyword>
  <keyword>Nervous disorder</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>
      <recruitment_details>139 epileptic participants from three participating centers (Neurological department of the Central (Vietnam-Sweden) Pediatrics Hospital, Neurological department of Children's Hospital N0 II at Ho Chi Minh City and the Children's Outpatient Clinic of the Mental Hospital at Ho Chi Minh City) were enrolled in this study to receive topiramate.</recruitment_details>
      <pre_assignment_details>Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Topiramate</title>
          <description>The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
              </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>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Topiramate</title>
          <description>The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="139"/>
          </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="10.1" spread="3.1" lower_limit="4" upper_limit="16"/>
                  </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="68" spread="51.1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71" spread="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment</title>
        <time_frame>Month 1, Month 3 and Month 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment</title>
        <time_frame>Month 1, Month 3 and Month 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Seizure Free Participants During the Last 4 Months of Treatment</title>
        <time_frame>Month 1, Month 3 and Month 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Seizure Free Participants During the Last 4 Months of Treatment</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks</title>
        <time_frame>Month 1, Month 3 and Month 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Partial seizures with ≥50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondarily generalized seizure with ≥50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Generalized tonic clonic seizure with ≥50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial seizures with ≥75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondarily generalized seizure with ≥75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Generalized tonic clonic seizure with ≥75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial seizures with 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondarily generalized seizure with 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Generalized tonic clonic seizure with 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks</title>
        <time_frame>Month 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt; 4 seizures/month with ≥50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt; 4 seizures/month with ≥75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt; 4 seizures/month 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-10 seizures/month with ≥50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-10 seizures/month with ≥75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-10 seizures/month with 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;10 seizures/month with ≥50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;10 seizures/month with ≥75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;10 seizures/month with 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>General Clinical Assessment Before and After Treatment</title>
        <description>The general clinical assessment is measured by clinical global impression scale. The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6).</description>
        <time_frame>Baseline (Day 0) and Month 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>General Clinical Assessment Before and After Treatment</title>
          <description>The general clinical assessment is measured by clinical global impression scale. The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6).</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1: Very good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6: Very good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 1: Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6: Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 1: Fairly good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6: Fairly good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 1: Medium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6: Medium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 1: Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6: Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment</title>
        <time_frame>Month 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topiramate</title>
            <description>The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>WIth previous treatment ≥50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WIth previous treatment ≥75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WIth previous treatment 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WIthout previous treatment ≥50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WIthout previous treatment ≥75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WIthout previous treatment 100%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 weeks</time_frame>
      <desc>Out of 139 participants, 132 participants were included in the safety analysis, 117 participants completed the trial, entering efficacy analysis and 22 participants were withdrawn from the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Topiramate</title>
          <description>The participants will receive an initial dose of 0.5mg/kg per oral (PO) in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="57" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Belly twitch</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mood disorder</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Attention disorder</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Itching</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="132"/>
              </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>Medical Director</name_or_title>
      <organization>Janssen-Cilag Taiwan</organization>
      <phone>886 2 23762155</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/NCT01689649
org study id: CR017830
secondary id: TOPMATEPY4049
secondary id: TOP-VN -0107
nct id: NCT01689649
lead sponsor: 
has dmc: No
The purpose of this dose optimization study is to assess tolerability and efficacy of
      topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive
      or have failed one anti-epileptic drug (AED) treatment in monotherapy.
This is an open label (all people know the identity of the intervention), dose optimization
      trial to assess the tolerability and efficacy of topiramate as monotherapy in recently
      (within 5 years) diagnosed patients with epilepsy. Treatment naive patients (patients who
      have never received the treatment before) and patients who failed on their first AED in
      monotherapy are allowed. Failure is defined as a lack of efficacy and/or tolerability of that
      AED and the reason for failure is recorded by the physician. A lack of efficacy is
      characterized when the patient has been treated with AED at target dose but the patient still
      has seizure. Topiramate will first be titrated up to an initial target dose that will be
      reached after 4-6 weeks. Further dose titration is guided by the clinical response of the
      individual patient, but the dose may not exceed a maximum of 400mg/day [9mg/kg/day for
      children]. If the patient uses an AED at entry, the AED will be fully tapered off over a
      period of 3 weeks, starting at the beginning of week 2, in order to have all patients on
      topiramate monotherapy at visit 3. Tapering the AED off may, however, extend this 3-week
      period if clinically indicated. Visits will be performed at baseline and after 2, 4, 8, 12,
      16 weeks. The total duration for each patient in the study will be 4 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment
time frame: Month 1, Month 3 and Month 4
measure: Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment
time frame: Month 1, Month 3 and Month 4
measure: Percentage of Seizure Free Participants During the Last 4 Months of Treatment
time frame: Month 1, Month 3 and Month 4
measure: Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks
time frame: Month 1, Month 3 and Month 4
measure: Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks
time frame: Month 4
measure: General Clinical Assessment Before and After Treatment
time frame: Baseline (Day 0) and Month 4
description: The general clinical assessment is measured by clinical global impression scale. The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6).
measure: Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment
time frame: Month 4
arm group label: Topiramate
arm group type: Experimental
description: For children: Children will start on topiramate with a dosage of 0.5mg/kg in the evening, followed by 0.5mg/kg/day weekly increments until an initial target dose of 3mg/kg/day is reached. The total daily topiramate dose for children may, not exceed 9mg/kg/day. For adult patients: Adult patients start on topiramate with a dosage of 25mg/day in the evening, followed by weekly increments of 25 mg/day until an initial target dose of 100mg/day is reached. The dose of topiramate may be increased to the optimal dose with weekly increments of 0.5mg/kg/day and of 25 mg/day for children and adults, respectively at the discretion of the investigator.
intervention type: Drug
intervention name: Topiramate
description: The patients will receive topiramate tablet twice daily orally up to 16 weeks.
arm group label: Topiramate
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Janssen-Cilag VIETNAM Clinical Trial
role: Study Director
affiliation: Janssen-Cilag VIETNAM
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Topiramate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 