<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/NCT02187809</url>
  </required_header>
  <id_info>
    <org_study_id>14362B</org_study_id>
    <nct_id>NCT02187809</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome</brief_title>
  <official_title>Multi-site, Prospective, Open-label, Long-term, Flexible Dose, Interventional Study to Evaluate the Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lundbeck A/S</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the long-term safety and tolerability of clobazam when administered for 1 year&#xD;
      as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated due to recruitment challenges&#xD;
  </why_stopped>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to Day 390</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose</measure>
    <time_frame>Up to Day 390</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years</measure>
    <time_frame>Baseline and from Day 0 to Day 360</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)</measure>
    <time_frame>Baseline and from Day 0 to Day 360</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures</measure>
    <time_frame>Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)</measure>
    <time_frame>Baseline and from Day 0 to Day 360</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)</measure>
    <time_frame>Baseline and from Day 0 to Day 360</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Dravet Syndrome</condition>
  <arm_group>
    <arm_group_label>Clobazam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clobazam</intervention_name>
    <arm_group_label>Clobazam</arm_group_label>
    <other_name>Onfi®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion and exclusion criteria for the patients who participated in lead-in Study&#xD;
        14362A will be transferred from the 14362A study and for the patients who did not&#xD;
        participate in lead-in Study 14362A the inclusion/exclusion is separately listed below.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient has a diagnosis of Dravet Syndrome supported by:&#xD;
&#xD;
               1. onset of seizures in the first year of life&#xD;
&#xD;
               2. history of fever-induced prolonged seizures as determined by the Investigator&#xD;
&#xD;
                    -  these may include prolonged (approximately 15 minutes or longer) hemi-clonic&#xD;
                       seizures&#xD;
&#xD;
               3. multiple seizure types which may include:&#xD;
&#xD;
                    -  generalised tonic-clonic (required for inclusion)&#xD;
&#xD;
                    -  clonic (required for inclusion)&#xD;
&#xD;
                    -  myoclonic jerks/seizures&#xD;
&#xD;
               4. history of normal development prior to seizure onset followed by development&#xD;
                  delay or regression after seizure onset&#xD;
&#xD;
               5. abnormal EEG consistent with Dravet Syndrome&#xD;
&#xD;
          2. The patient is currently receiving a stable dose of clobazam of at least 0.5 mg/kg/day&#xD;
             (maximum 20 mg/day) for at least 3 months&#xD;
&#xD;
        Other protocol-defined inclusion and exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email contact via H. Lundbeck A/S</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>US010</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US012</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US001</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US003</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US005</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US0011</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US006</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US004</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MX003</name>
      <address>
        <city>Guadalajara</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <results_first_submitted>October 28, 2016</results_first_submitted>
  <results_first_submitted_qc>December 22, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 15, 2017</results_first_posted>
  <last_update_submitted>February 22, 2017</last_update_submitted>
  <last_update_submitted_qc>February 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsies, Myoclonic</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clobazam</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Clobazam</title>
          <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>The study was terminated</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>At the time of study termination, one patient had had been treated</population>
      <group_list>
        <group group_id="B1">
          <title>Clobazam</title>
          <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13" lower_limit="13" upper_limit="13"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</title>
        <time_frame>Up to Day 390</time_frame>
        <population>At the time of study termination, only one patient had received IMP. No adverse events were observed in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Clobazam</title>
            <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</title>
          <population>At the time of study termination, only one patient had received IMP. No adverse events were observed in the study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose</title>
        <time_frame>Up to Day 390</time_frame>
        <population>At the time of study termination, only one patient had received IMP. No adverse events were observed in the study</population>
        <group_list>
          <group group_id="O1">
            <title>Clobazam</title>
            <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose</title>
          <population>At the time of study termination, only one patient had received IMP. No adverse events were observed in the study</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years</title>
        <time_frame>Baseline and from Day 0 to Day 360</time_frame>
        <population>At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient.</population>
        <group_list>
          <group group_id="O1">
            <title>Clobazam</title>
            <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</description>
          </group>
        </group_list>
        <measure>
          <title>Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years</title>
          <population>At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)</title>
        <time_frame>Baseline and from Day 0 to Day 360</time_frame>
        <population>At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient.</population>
        <group_list>
          <group group_id="O1">
            <title>Clobazam</title>
            <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)</title>
          <population>At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures</title>
        <time_frame>Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal</time_frame>
        <population>At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.</population>
        <group_list>
          <group group_id="O1">
            <title>Clobazam</title>
            <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures</title>
          <population>At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)</title>
        <time_frame>Baseline and from Day 0 to Day 360</time_frame>
        <population>At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.</population>
        <group_list>
          <group group_id="O1">
            <title>Clobazam</title>
            <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)</title>
          <population>At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)</title>
        <time_frame>Baseline and from Day 0 to Day 360</time_frame>
        <population>At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.</population>
        <group_list>
          <group group_id="O1">
            <title>Clobazam</title>
            <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)</title>
          <population>At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One patient was treated for 33 days before study termination</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Clobazam</title>
          <description>A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally&#xD;
Clobazam</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="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </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>
    <limitations_and_caveats>Early termination leading to small numbers of subjects treated and no analysis. One patient was treated for 33 days.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>H. Lundbeck</name_or_title>
      <organization>H. Lundbeck A/S</organization>
      <email>LundbeckClinicalTrials@Lundbeck.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02187809
org study id: 14362B
nct id: NCT02187809
lead sponsor: 
has dmc: Yes
To investigate the long-term safety and tolerability of clobazam when administered for 1 year
      as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: Up to Day 390
measure: Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose
time frame: Up to Day 390
measure: Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years
time frame: Baseline and from Day 0 to Day 360
measure: Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)
time frame: Baseline and from Day 0 to Day 360
measure: Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures
time frame: Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal
measure: Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)
time frame: Baseline and from Day 0 to Day 360
measure: Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)
time frame: Baseline and from Day 0 to Day 360
arm group label: Clobazam
arm group type: Experimental
description: A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally
intervention type: Drug
intervention name: Clobazam
arm group label: Clobazam
other name: Onfi®
criteria: 
gender: All
minimum age: 1 Year
maximum age: 16 Years
healthy volunteers: No
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@lundbeck.com
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Mexico
country: United States
responsible party type: Sponsor
mesh term: Epilepsies, Myoclonic
mesh term: Syndrome
mesh term: Clobazam
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of subjects treated and no analysis. One patient was treated for 33 days.
point of contact: 