<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/NCT04417543</url>
  </required_header>
  <id_info>
    <org_study_id>Memantine in epilepsy</org_study_id>
    <nct_id>NCT04417543</nct_id>
  </id_info>
  <brief_title>Effect of Memantine on Cognitive Impairment in Patients With Epilepsy</brief_title>
  <official_title>Effect of Memantine on Cognitive Impairment in Patients With Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the efficacy of memantine on improving the cognitive impairment in patient with&#xD;
      epilepsy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epilepsy is a complex disorder, which involves much more than seizures, encompassing a range&#xD;
      of associated comorbid health conditions that can have significant health and quality-of-life&#xD;
      implications. Of these comorbidities, cognitive impairment is one of the most common and&#xD;
      distressing aspects of epilepsy.&#xD;
&#xD;
      Excito-toxicity, mediated by glutamate acting on N-methyl-D-aspartate (NMDA) receptors in the&#xD;
      hippocampus, can cause memory dysfunction in epilepsy .&#xD;
&#xD;
      Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type&#xD;
      glutamate receptor . It also has antioxidant property and increases production of brain&#xD;
      derived neurotropic factor (BDNF)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>100 patients divided into two groups each group 50patients</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Memory Assessment Scale (MAS)</measure>
    <time_frame>1.5years</time_frame>
    <description>This comprehensive battery assesses short-term, verbal and visual memory functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wechsler Adult Intelligence Scale (WAIS)</measure>
    <time_frame>1.5years</time_frame>
    <description>Intelligence quotient (IQ) tests are the primary clinical instruments used to measure adult and adolescent intellience.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Visuospatial Memory Test-Revised (BVMT-R)</measure>
    <time_frame>1.5years</time_frame>
    <description>The current revised version of the BVMT, a visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Memantine hydrochloride group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>included 50 patients who received memantine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>included 50 patients who received placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Memantine Hydrochloride</intervention_name>
    <description>Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor .Memantine hydrochloride tablet was started at the dose of 5 mg once daily orally, and the same dose was given for 3months and dose is titrated to 10 mg once daily orally for the remaining 3months. Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.</description>
    <arm_group_label>Memantine hydrochloride group</arm_group_label>
    <other_name>Memantine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with idiopathic epilepsy.&#xD;
&#xD;
          -  Normal brain imaging (CT brain).&#xD;
&#xD;
          -  Patients on anti epileptic drugs more than 6 months.&#xD;
&#xD;
          -  No more than two fits per month.&#xD;
&#xD;
          -  Score of Mini mental state examination (10-24), mild and moderate cognitive&#xD;
             impairment.&#xD;
&#xD;
          -  No other medical disorders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Progressive neurological diseases.&#xD;
&#xD;
          -  Abnormal brain imaging (CT brain).&#xD;
&#xD;
          -  More than two fits per month.&#xD;
&#xD;
          -  Patients with severe cognitive impairment, score of MMSE less than10.&#xD;
&#xD;
          -  Patients with severe medical disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Salma Mohmed Fahmy</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Bell B, Lin JJ, Seidenberg M, Hermann B. The neurobiology of cognitive disorders in temporal lobe epilepsy. Nat Rev Neurol. 2011 Mar;7(3):154-64. doi: 10.1038/nrneurol.2011.3. Epub 2011 Feb 8.</citation>
    <PMID>21304484</PMID>
  </reference>
  <reference>
    <citation>Aggleton JP. Multiple anatomical systems embedded within the primate medial temporal lobe: implications for hippocampal function. Neurosci Biobehav Rev. 2012 Aug;36(7):1579-96. doi: 10.1016/j.neubiorev.2011.09.005. Epub 2011 Sep 24.</citation>
    <PMID>21964564</PMID>
  </reference>
  <reference>
    <citation>Alvarez PS, Simao F, Hemb M, Xavier LL, Nunes ML. Effects of undernourishment, recurrent seizures and enriched environment during early life in hippocampal morphology. Int J Dev Neurosci. 2014 Apr;33:81-7. doi: 10.1016/j.ijdevneu.2013.12.004. Epub 2013 Dec 21.</citation>
    <PMID>24365760</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Salma Mohmed</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Memantine</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/NCT04417543
org study id: Memantine in epilepsy
nct id: NCT04417543
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Evaluate the efficacy of memantine on improving the cognitive impairment in patient with
      epilepsy
Epilepsy is a complex disorder, which involves much more than seizures, encompassing a range
      of associated comorbid health conditions that can have significant health and quality-of-life
      implications. Of these comorbidities, cognitive impairment is one of the most common and
      distressing aspects of epilepsy.

      Excito-toxicity, mediated by glutamate acting on N-methyl-D-aspartate (NMDA) receptors in the
      hippocampus, can cause memory dysfunction in epilepsy .

      Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type
      glutamate receptor . It also has antioxidant property and increases production of brain
      derived neurotropic factor (BDNF)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 100 patients divided into two groups each group 50patients
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Memory Assessment Scale (MAS)
time frame: 1.5years
description: This comprehensive battery assesses short-term, verbal and visual memory functioning.
measure: Wechsler Adult Intelligence Scale (WAIS)
time frame: 1.5years
description: Intelligence quotient (IQ) tests are the primary clinical instruments used to measure adult and adolescent intellience.
measure: Brief Visuospatial Memory Test-Revised (BVMT-R)
time frame: 1.5years
description: The current revised version of the BVMT, a visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials.
arm group label: Memantine hydrochloride group
arm group type: Active Comparator
description: included 50 patients who received memantine
arm group label: Placebo group
arm group type: Placebo Comparator
description: included 50 patients who received placebo
intervention type: Drug
intervention name: Memantine Hydrochloride
description: Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor .Memantine hydrochloride tablet was started at the dose of 5 mg once daily orally, and the same dose was given for 3months and dose is titrated to 10 mg once daily orally for the remaining 3months. Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.
arm group label: Memantine hydrochloride group
other name: Memantine
intervention type: Drug
intervention name: Placebo
description: Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Bell B, Lin JJ, Seidenberg M, Hermann B. The neurobiology of cognitive disorders in temporal lobe epilepsy. Nat Rev Neurol. 2011 Mar;7(3):154-64. doi: 10.1038/nrneurol.2011.3. Epub 2011 Feb 8.
PMID: 21304484
citation: Aggleton JP. Multiple anatomical systems embedded within the primate medial temporal lobe: implications for hippocampal function. Neurosci Biobehav Rev. 2012 Aug;36(7):1579-96. doi: 10.1016/j.neubiorev.2011.09.005. Epub 2011 Sep 24.
PMID: 21964564
citation: Alvarez PS, Simao F, Hemb M, Xavier LL, Nunes ML. Effects of undernourishment, recurrent seizures and enriched environment during early life in hippocampal morphology. Int J Dev Neurosci. 2014 Apr;33:81-7. doi: 10.1016/j.ijdevneu.2013.12.004. Epub 2013 Dec 21.
PMID: 24365760
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Salma Mohmed
investigator title: Doctor
mesh term: Epilepsy
mesh term: Cognitive Dysfunction
mesh term: Memantine