<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/NCT02208492</url>
  </required_header>
  <id_info>
    <org_study_id>4-2011-0365</org_study_id>
    <nct_id>NCT02208492</nct_id>
  </id_info>
  <brief_title>The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as&#xD;
      levetiracetam are reported to have less adverse effect in children but not many studies have&#xD;
      systematically reviewed the subject. This study aims to prospectively evaluate the effect of&#xD;
      levetiracetam on neurocognition, behavioral issues and quality of life, as well as its&#xD;
      seizure control efficacy and other adverse events in pediatric epilepsy patients, in&#xD;
      comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed&#xD;
      for both partial and generalized seizures, despite its well known side effects.&#xD;
&#xD;
      This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from&#xD;
      age 4 to 16 woh will be randomized into two groups, which will be prescribed with&#xD;
      levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and&#xD;
      life evaluations of the patients will be performed at baseline period and after the 52 weeks&#xD;
      of study period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine)</measure>
    <time_frame>52 weeks</time_frame>
    <description>changes in a series of follow-up neurocognitive, behavioral, and emotional function tests (Korean Wechsler Intelligence Scale for Children-Third edition (K-WISC-III, for subjects 6-16 years old)19, 20 or the Korean Weschler Preschool and Primary Scale of Intelligence-Third edition (K-WIPSSI-III, for ages 4-6), Korean-Child Behavior Checklist (K-CBCL), Children's Depression Inventory (CDI) 24 and Revised Children's Manifest Anxiety Scale (RCMAS))</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seizure control efficacy</measure>
    <time_frame>52 weeks</time_frame>
    <description>Comparison of baseline frequency to final follow-up frequency during the last 24 weeks of the maintenance period(at last visit at 52 week time point)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Focal Epilepsy</condition>
  <arm_group>
    <arm_group_label>Levetiracetam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Carabamazepine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levetiracetam</intervention_name>
    <description>Levetiracetam is a second-generation antiepileptic drug that has been approved for the treatment of epilepsy in both children and adults. This anticonvulsant works by binding to the synaptic vesicle protein 2A resulting in a possible effect on neurotransmitter release from presynaptic vesicles, while the exact mechanism of action is still unclear. In both adults and children, levetiracetam treatment in has a proven efficacy in both localization-related and generalized epilepsies. In contrast to first generation, levetiracetam reports less side effects of somnolence or lethargy, but behavioral adverse events, such as changed mood state, aggression, and irritability are noted, but only a few studies have reported such effects in a systemic fashion.</description>
    <arm_group_label>Levetiracetam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carabamazepine</intervention_name>
    <description>Carbamazepine, a first-generation antiepileptic medication, stabilizes the inactivated state of voltage-gated sodium channels, making fewer of these channels available to subsequently open, which leaves the affected cells less excitable and less seizure prone. It is approved for both focal seizures and generalized tonic-clonic or combined seizures for adults and children.</description>
    <arm_group_label>Carabamazepine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients from age 4 to 16, who have been diagnosed with focal epilepsy&#xD;
&#xD;
          2. Patients who have experienced minimal two unprovoked seizures, or patients who have&#xD;
             had one unprovoked seizure and have shown focal abnormality in the EEG&#xD;
&#xD;
          3. Patients who have not received any antiepileptic medications prior to the study (Those&#xD;
             who have been treated with rescue medication are eligible)&#xD;
&#xD;
          4. Patients with eligible consent or with legal guardians have given official consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with progressive CNS disease, or systemic illness&#xD;
&#xD;
          2. Patients with level of SGOT/SPGT above the doubled normal level or BUN/Creatinine&#xD;
             above the 3 times of the normal range&#xD;
&#xD;
          3. Patients who had used other anti-epileptic medication during any period of the trial,&#xD;
             including baseline period. (Benzodiazepine used as rescue therapy is acceptable)&#xD;
&#xD;
          4. Patients who show hypersensitive reaction to the study medication.&#xD;
&#xD;
          5. Patients with any psychological problems.&#xD;
&#xD;
          6. Patients deemed inappropriate for the study by the investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>December 8, 2014</last_update_submitted>
  <last_update_submitted_qc>December 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Levetiracetam, Carabamazepine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsies, Partial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levetiracetam</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02208492
org study id: 4-2011-0365
nct id: NCT02208492
lead sponsor: 
has dmc: No
Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as
      levetiracetam are reported to have less adverse effect in children but not many studies have
      systematically reviewed the subject. This study aims to prospectively evaluate the effect of
      levetiracetam on neurocognition, behavioral issues and quality of life, as well as its
      seizure control efficacy and other adverse events in pediatric epilepsy patients, in
      comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed
      for both partial and generalized seizures, despite its well known side effects.

      This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from
      age 4 to 16 woh will be randomized into two groups, which will be prescribed with
      levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and
      life evaluations of the patients will be performed at baseline period and after the 52 weeks
      of study period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine)
time frame: 52 weeks
description: changes in a series of follow-up neurocognitive, behavioral, and emotional function tests (Korean Wechsler Intelligence Scale for Children-Third edition (K-WISC-III, for subjects 6-16 years old)19, 20 or the Korean Weschler Preschool and Primary Scale of Intelligence-Third edition (K-WIPSSI-III, for ages 4-6), Korean-Child Behavior Checklist (K-CBCL), Children's Depression Inventory (CDI) 24 and Revised Children's Manifest Anxiety Scale (RCMAS))
measure: Seizure control efficacy
time frame: 52 weeks
description: Comparison of baseline frequency to final follow-up frequency during the last 24 weeks of the maintenance period(at last visit at 52 week time point)
arm group label: Levetiracetam
arm group type: Experimental
arm group label: Carabamazepine
arm group type: Active Comparator
intervention type: Drug
intervention name: Levetiracetam
description: Levetiracetam is a second-generation antiepileptic drug that has been approved for the treatment of epilepsy in both children and adults. This anticonvulsant works by binding to the synaptic vesicle protein 2A resulting in a possible effect on neurotransmitter release from presynaptic vesicles, while the exact mechanism of action is still unclear. In both adults and children, levetiracetam treatment in has a proven efficacy in both localization-related and generalized epilepsies. In contrast to first generation, levetiracetam reports less side effects of somnolence or lethargy, but behavioral adverse events, such as changed mood state, aggression, and irritability are noted, but only a few studies have reported such effects in a systemic fashion.
arm group label: Levetiracetam
intervention type: Drug
intervention name: Carabamazepine
description: Carbamazepine, a first-generation antiepileptic medication, stabilizes the inactivated state of voltage-gated sodium channels, making fewer of these channels available to subsequently open, which leaves the affected cells less excitable and less seizure prone. It is approved for both focal seizures and generalized tonic-clonic or combined seizures for adults and children.
arm group label: Carabamazepine
criteria: 
gender: All
minimum age: 4 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Epilepsies, Partial
mesh term: Levetiracetam