<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/NCT03245099</url>
  </required_header>
  <id_info>
    <org_study_id>MONCSE</org_study_id>
    <nct_id>NCT03245099</nct_id>
  </id_info>
  <brief_title>Management of Non Convulsive Status Epilepticus</brief_title>
  <official_title>Management of Non Convulsive Status Epilepticus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non convulsive status epilepticus is a persistent change in behavioural and or mental process&#xD;
      from baseline associated with continuous epileptiform activity in electroencephalograph,it&#xD;
      occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in&#xD;
      intensive care unit patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early recognition and treatment of non convulsive status epilepticus are essential to&#xD;
      optimize response to treatment and to prevent neurological sequelae, over diagnosis and&#xD;
      aggressive use of anticonvulsants can contribute to morbidity and mortality.It displays great&#xD;
      diversity in response to anticonvulsants,therefore treatment in intensive care units is&#xD;
      required for selected cases .The aetiology and clinical forms are strong predictors for the&#xD;
      overall prognosis.Treatment is poorly understood and follows the standard regimen for&#xD;
      convulsive status epilepticus&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cured patients</measure>
    <time_frame>An average of 1 year</time_frame>
    <description>Number of cured patients</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Status Epilepticus</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cross sectional</intervention_name>
    <description>Electroencephalograph will be done to all patients who fulfill the inclusion criteria to detect presence of electrical discharge with in the brain.Complete blood count ,liver function test ,kidney function test ,blood glucose level and serum electrolytes will be done to selected cases according to the clinical presentation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Patients 1-18 years&#xD;
&#xD;
          -  Generalized tonic clonic convulsions and prolonged post ictal period more than 30&#xD;
             minutes&#xD;
&#xD;
          -  Un explained coma ,stupor,confusion and psychic or speech disorder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who have generalized tonic colonic convulsions and prolonged post ictal state&#xD;
             more than 30 minutes&#xD;
&#xD;
          -  patients presented with un explained psychic or speech disorder&#xD;
&#xD;
          -  patients presented with stupor or confusion&#xD;
&#xD;
          -  Patients presented with un explained coma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with progressive neurological disease&#xD;
&#xD;
          -  Patients with severe cerebral anoxia&#xD;
&#xD;
          -  Patients with liver or hepatic impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rewaa Mohammed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gamal Askar, MD</last_name>
    <phone>01111686162</phone>
    <email>Gamal.askar@med.au.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eman Fathallah, MD</last_name>
    <phone>01115191158</phone>
    <email>Mean.mohamed@med.au.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AssiutU</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Rewaa</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Rewaa Mohammed</investigator_full_name>
    <investigator_title>Principlal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Status Epilepticus</mesh_term>
  </condition_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/NCT03245099
org study id: MONCSE
nct id: NCT03245099
lead sponsor: 
has dmc: Yes
Non convulsive status epilepticus is a persistent change in behavioural and or mental process
      from baseline associated with continuous epileptiform activity in electroencephalograph,it
      occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in
      intensive care unit patients
Early recognition and treatment of non convulsive status epilepticus are essential to
      optimize response to treatment and to prevent neurological sequelae, over diagnosis and
      aggressive use of anticonvulsants can contribute to morbidity and mortality.It displays great
      diversity in response to anticonvulsants,therefore treatment in intensive care units is
      required for selected cases .The aetiology and clinical forms are strong predictors for the
      overall prognosis.Treatment is poorly understood and follows the standard regimen for
      convulsive status epilepticus
observational model: Other
time perspective: Cross-Sectional
measure: Number of cured patients
time frame: An average of 1 year
description: Number of cured patients
intervention type: Other
intervention name: cross sectional
description: Electroencephalograph will be done to all patients who fulfill the inclusion criteria to detect presence of electrical discharge with in the brain.Complete blood count ,liver function test ,kidney function test ,blood glucose level and serum electrolytes will be done to selected cases according to the clinical presentation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: 18 Years
healthy volunteers: No
last name: Rewaa Mohammed, MD
role: Principal Investigator
affiliation: Assiut University
last name: Gamal Askar, MD
phone: 01111686162
email: Gamal.askar@med.au.edu.eg
last name: Eman Fathallah, MD
phone: 01115191158
email: Mean.mohamed@med.au.edu.eg
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Rewaa Mohammed
investigator title: Principlal investigator
mesh term: Status Epilepticus