<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/NCT03819413</url>
  </required_header>
  <id_info>
    <org_study_id>NMOSD In Assiut University</org_study_id>
    <nct_id>NCT03819413</nct_id>
  </id_info>
  <brief_title>Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital</brief_title>
  <official_title>Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuromyelitis Optica Spectrum Disorders (NMOSD) are a group of inflammatory demyelinating&#xD;
      disorders of the central nervous system. Although NMOSD occurs much more commonly in nations&#xD;
      with a predominately non-Caucasian population, NMOSD are underestimated in Egypt and&#xD;
      frequently misdiagnosed as multiple sclerosis (MS). In this study, by investigating serum&#xD;
      anti-aquaporin (AQP) 4 and anti-MOG antibody of patients suspected to have NMOSD attending&#xD;
      the Neurology and Psychiatry department of Assiut University Hospital, investigators aim to&#xD;
      determine the relative frequency, clinical and radiological characteristics of NMOSD in upper&#xD;
      Egypt community and compare it with other populations of different races.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neuromyelitis Optica Spectrum Disorders (NMOSD) are a group of inflammatory demyelinating&#xD;
      disorders of the central nervous system characterized by episodes of immune-mediated&#xD;
      demyelination and axonal damage mainly involving optic nerves and spinal cord. The discovery&#xD;
      of a disease-specific serum NMO-immunoglobulin G (IgG) antibody that selectively binds&#xD;
      aquaporin-4 (AQP4) has not only distinguish NMO from MS but also enabled an appreciation for&#xD;
      the wide spectrum of this disorder. Another autoantibody is the Myelin oligodendrocyte&#xD;
      glycoprotein (MOGIgG) antibody that has been increasingly reported in a variety of central&#xD;
      nervous system neuroinflammatory conditions including patients with phenotypes typical for&#xD;
      NMOSD. Overall, NMO occurs much more commonly in nations with a predominately non-Caucasian&#xD;
      population,and estimated to be as high as 10 per 100,000. Differentiation of MS from NMOSD is&#xD;
      critically important because disease modifying treatment for MS, are inefficacious in or may&#xD;
      aggravate NMOSD. However, in Africa and Middle East, publications and studies are rare and&#xD;
      most often focus on isolated cases that clearly do not reflect the epidemiological reality in&#xD;
      this area. Investigators believe that detailed assessment of serum AQP4 antibody as well as&#xD;
      anti-MOG antibody in Egyptian patients with suspected NMOSD or those with idiopathic&#xD;
      inflammatory demyelinating central nervous system diseases (IIDCD) other than typical MS&#xD;
      would be beneficial and Eventually will help to avoid unnecessary investigations and&#xD;
      treatments, recurrent and prolonged hospital course, significant morbidity, and even death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the percentage of increase in NMOSD diagnostic rates by screening for serum anti-AQP4 and anti-MOG antibodies</measure>
    <time_frame>one year period</time_frame>
    <description>To assess the role of screening for Serum anti-AQP4 and anti-MOG antibodies in patients with idiopathic inflammatory central nervous system demyelinating disorders on diagnostic rates of NMOSD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>percentage of patients were misdiagnosed as MS after screening for serum anti-AQP4 and anti-MOG antibodies</measure>
    <time_frame>one year period</time_frame>
    <description>To measure the role of Serum anti-AQP4 and anti-MOG antibodies to differentiate suspicious cases from MS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the percentage of increase of anti-MOG associated diseases after screening for serum anti-MOG antibodies</measure>
    <time_frame>one year period</time_frame>
    <description>To assess the impact of screening for serum anti-MOG antibodies on diagnostic rates of anti-MOG associated diseases</description>
  </secondary_outcome>
  <enrollment type="Actual">90</enrollment>
  <condition>Neuromyelitis Optica Spectrum Disorder</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum aquaporin 4 antibody (AQP-4-Ab)</intervention_name>
    <description>All patients suspected to have NMOSD according to the recent diagnostic criteria will be examined for serum aquaporin 4 antibody (AQP-4-Ab) and serum myelin oligodendrocyte glycoprotein antibody (anti-MOG)</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum MOG antibody (anti-MOG)</intervention_name>
    <description>All patients suspected to have NMOSD according to the recent diagnostic criteria will be examined for serum myelin oligodendrocyte glycoprotein antibody (anti-MOG) if they tested negative for serum aquaporin 4 antibody (AQP-4-Ab)</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI brain, spine and orbit</intervention_name>
    <description>All patients suspected to have NMOSD according to the recent diagnostic criteria will have MRI brain, spine and orbit with Gadolinium</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients suspected to have NMOSD according to the recent diagnostic criteria attending&#xD;
        or referred to Neurology and Psychiatry department of Assiut University hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All cases that fulfill the international 2015 consensus criteria of NMOSD&#xD;
&#xD;
          -  Any episode suggestive of idiopathic inflammatory demyelinating central nervous system&#xD;
             disease including&#xD;
&#xD;
               -  longitudinally extensive transverse myelitis (LETM) or optic neuritis (ON) plus&#xD;
                  Cerebral or Brainstem syndrome (LETM or ON PLUS)&#xD;
&#xD;
               -  optic neuritis (ON)&#xD;
&#xD;
               -  longitudinally extensive transverse myelitis (LETM),&#xD;
&#xD;
               -  Transverse myelitis with non-extensive lesion (NETM)&#xD;
&#xD;
               -  Acute encephalomyelitis (ADEM).&#xD;
&#xD;
          -  Atypical MS cases (atypical clinical presentation, course, radiological findings or&#xD;
             atypical response to treatment)&#xD;
&#xD;
          -  Age: all patients of both sexes and all age groups will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for suspected NMOSD were not met&#xD;
&#xD;
          -  An alternate diagnosis became apparent&#xD;
&#xD;
          -  if no serum sample was supplied&#xD;
&#xD;
          -  Subject declined to provide written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noha A Abo Elfotoh, prof</last_name>
    <role>Study Director</role>
    <affiliation>Assuit university hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <zip>71511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/centers-programs/center-multiple-sclerosis-autoimmune-neurology/research/neuromyelitis-optica</url>
    <description>Neuromyelitis Spectrum Disorders</description>
  </link>
  <reference>
    <citation>Weinshenker BG, Wingerchuk DM. Neuromyelitis Spectrum Disorders. Mayo Clin Proc. 2017 Apr;92(4):663-679. doi: 10.1016/j.mayocp.2016.12.014.</citation>
    <PMID>28385199</PMID>
  </reference>
  <reference>
    <citation>Pandit L, Asgari N, Apiwattanakul M, Palace J, Paul F, Leite MI, Kleiter I, Chitnis T; GJCF International Clinical Consortium &amp; Biorepository for Neuromyelitis Optica. Demographic and clinical features of neuromyelitis optica: A review. Mult Scler. 2015 Jun;21(7):845-53. doi: 10.1177/1352458515572406. Epub 2015 Apr 28.</citation>
    <PMID>25921037</PMID>
  </reference>
  <reference>
    <citation>Lennon VA, Wingerchuk DM, Kryzer TJ, Pittock SJ, Lucchinetti CF, Fujihara K, Nakashima I, Weinshenker BG. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet. 2004 Dec 11-17;364(9451):2106-12. doi: 10.1016/S0140-6736(04)17551-X.</citation>
    <PMID>15589308</PMID>
  </reference>
  <reference>
    <citation>Di Pauli F, Reindl M, Berger T. New clinical implications of anti-myelin oligodendrocyte glycoprotein antibodies in children with CNS demyelinating diseases. Mult Scler Relat Disord. 2018 May;22:35-37. doi: 10.1016/j.msard.2018.02.023. Epub 2018 Feb 22.</citation>
    <PMID>29524760</PMID>
  </reference>
  <reference>
    <citation>Kim SM, Kim SJ, Lee HJ, Kuroda H, Palace J, Fujihara K. Differential diagnosis of neuromyelitis optica spectrum disorders. Ther Adv Neurol Disord. 2017 Jul;10(7):265-289. doi: 10.1177/1756285617709723. Epub 2017 May 24.</citation>
    <PMID>28670343</PMID>
  </reference>
  <reference>
    <citation>Holroyd KB, Aziz F, Szolics M, Alsaadi T, Levy M, Schiess N. Prevalence and characteristics of transverse myelitis and neuromyelitis optica spectrum disorders in the United Arab Emirates: A multicenter, retrospective study. Clin Exp Neuroimmunol. 2018 Aug;9(3):155-161. doi: 10.1111/cen3.12458. Epub 2018 May 7.</citation>
    <PMID>30090123</PMID>
  </reference>
  <reference>
    <citation>Jarius S, Paul F, Aktas O, Asgari N, Dale RC, de Seze J, Franciotta D, Fujihara K, Jacob A, Kim HJ, Kleiter I, Kumpfel T, Levy M, Palace J, Ruprecht K, Saiz A, Trebst C, Weinshenker BG, Wildemann B. MOG encephalomyelitis: international recommendations on diagnosis and antibody testing. J Neuroinflammation. 2018 May 3;15(1):134. doi: 10.1186/s12974-018-1144-2.</citation>
    <PMID>29724224</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>doaa mokhtar mahmoud</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Neuromyelitis Optica Spectrum Disorder</keyword>
  <keyword>prevalence</keyword>
  <keyword>anti-AQP4</keyword>
  <keyword>anti-MOG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuromyelitis Optica</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03819413
org study id: NMOSD In Assiut University
nct id: NCT03819413
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Neuromyelitis Optica Spectrum Disorders (NMOSD) are a group of inflammatory demyelinating
      disorders of the central nervous system. Although NMOSD occurs much more commonly in nations
      with a predominately non-Caucasian population, NMOSD are underestimated in Egypt and
      frequently misdiagnosed as multiple sclerosis (MS). In this study, by investigating serum
      anti-aquaporin (AQP) 4 and anti-MOG antibody of patients suspected to have NMOSD attending
      the Neurology and Psychiatry department of Assiut University Hospital, investigators aim to
      determine the relative frequency, clinical and radiological characteristics of NMOSD in upper
      Egypt community and compare it with other populations of different races.
Neuromyelitis Optica Spectrum Disorders (NMOSD) are a group of inflammatory demyelinating
      disorders of the central nervous system characterized by episodes of immune-mediated
      demyelination and axonal damage mainly involving optic nerves and spinal cord. The discovery
      of a disease-specific serum NMO-immunoglobulin G (IgG) antibody that selectively binds
      aquaporin-4 (AQP4) has not only distinguish NMO from MS but also enabled an appreciation for
      the wide spectrum of this disorder. Another autoantibody is the Myelin oligodendrocyte
      glycoprotein (MOGIgG) antibody that has been increasingly reported in a variety of central
      nervous system neuroinflammatory conditions including patients with phenotypes typical for
      NMOSD. Overall, NMO occurs much more commonly in nations with a predominately non-Caucasian
      population,and estimated to be as high as 10 per 100,000. Differentiation of MS from NMOSD is
      critically important because disease modifying treatment for MS, are inefficacious in or may
      aggravate NMOSD. However, in Africa and Middle East, publications and studies are rare and
      most often focus on isolated cases that clearly do not reflect the epidemiological reality in
      this area. Investigators believe that detailed assessment of serum AQP4 antibody as well as
      anti-MOG antibody in Egyptian patients with suspected NMOSD or those with idiopathic
      inflammatory demyelinating central nervous system diseases (IIDCD) other than typical MS
      would be beneficial and Eventually will help to avoid unnecessary investigations and
      treatments, recurrent and prolonged hospital course, significant morbidity, and even death.
observational model: Case-Only
time perspective: Prospective
measure: the percentage of increase in NMOSD diagnostic rates by screening for serum anti-AQP4 and anti-MOG antibodies
time frame: one year period
description: To assess the role of screening for Serum anti-AQP4 and anti-MOG antibodies in patients with idiopathic inflammatory central nervous system demyelinating disorders on diagnostic rates of NMOSD
measure: percentage of patients were misdiagnosed as MS after screening for serum anti-AQP4 and anti-MOG antibodies
time frame: one year period
description: To measure the role of Serum anti-AQP4 and anti-MOG antibodies to differentiate suspicious cases from MS
measure: the percentage of increase of anti-MOG associated diseases after screening for serum anti-MOG antibodies
time frame: one year period
description: To assess the impact of screening for serum anti-MOG antibodies on diagnostic rates of anti-MOG associated diseases
intervention type: Diagnostic Test
intervention name: serum aquaporin 4 antibody (AQP-4-Ab)
description: All patients suspected to have NMOSD according to the recent diagnostic criteria will be examined for serum aquaporin 4 antibody (AQP-4-Ab) and serum myelin oligodendrocyte glycoprotein antibody (anti-MOG)
intervention type: Diagnostic Test
intervention name: serum MOG antibody (anti-MOG)
description: All patients suspected to have NMOSD according to the recent diagnostic criteria will be examined for serum myelin oligodendrocyte glycoprotein antibody (anti-MOG) if they tested negative for serum aquaporin 4 antibody (AQP-4-Ab)
intervention type: Diagnostic Test
intervention name: MRI brain, spine and orbit
description: All patients suspected to have NMOSD according to the recent diagnostic criteria will have MRI brain, spine and orbit with Gadolinium
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 75 Years
healthy volunteers: No
last name: Noha A Abo Elfotoh, prof
role: Study Director
affiliation: Assuit university hospital
facility: 
country: Egypt
url: https://www.mayo.edu/research/centers-programs/center-multiple-sclerosis-autoimmune-neurology/research/neuromyelitis-optica
description: Neuromyelitis Spectrum Disorders
citation: Weinshenker BG, Wingerchuk DM. Neuromyelitis Spectrum Disorders. Mayo Clin Proc. 2017 Apr;92(4):663-679. doi: 10.1016/j.mayocp.2016.12.014.
PMID: 28385199
citation: Pandit L, Asgari N, Apiwattanakul M, Palace J, Paul F, Leite MI, Kleiter I, Chitnis T; GJCF International Clinical Consortium & Biorepository for Neuromyelitis Optica. Demographic and clinical features of neuromyelitis optica: A review. Mult Scler. 2015 Jun;21(7):845-53. doi: 10.1177/1352458515572406. Epub 2015 Apr 28.
PMID: 25921037
citation: Lennon VA, Wingerchuk DM, Kryzer TJ, Pittock SJ, Lucchinetti CF, Fujihara K, Nakashima I, Weinshenker BG. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet. 2004 Dec 11-17;364(9451):2106-12. doi: 10.1016/S0140-6736(04)17551-X.
PMID: 15589308
citation: Di Pauli F, Reindl M, Berger T. New clinical implications of anti-myelin oligodendrocyte glycoprotein antibodies in children with CNS demyelinating diseases. Mult Scler Relat Disord. 2018 May;22:35-37. doi: 10.1016/j.msard.2018.02.023. Epub 2018 Feb 22.
PMID: 29524760
citation: Kim SM, Kim SJ, Lee HJ, Kuroda H, Palace J, Fujihara K. Differential diagnosis of neuromyelitis optica spectrum disorders. Ther Adv Neurol Disord. 2017 Jul;10(7):265-289. doi: 10.1177/1756285617709723. Epub 2017 May 24.
PMID: 28670343
citation: Holroyd KB, Aziz F, Szolics M, Alsaadi T, Levy M, Schiess N. Prevalence and characteristics of transverse myelitis and neuromyelitis optica spectrum disorders in the United Arab Emirates: A multicenter, retrospective study. Clin Exp Neuroimmunol. 2018 Aug;9(3):155-161. doi: 10.1111/cen3.12458. Epub 2018 May 7.
PMID: 30090123
citation: Jarius S, Paul F, Aktas O, Asgari N, Dale RC, de Seze J, Franciotta D, Fujihara K, Jacob A, Kim HJ, Kleiter I, Kumpfel T, Levy M, Palace J, Ruprecht K, Saiz A, Trebst C, Weinshenker BG, Wildemann B. MOG encephalomyelitis: international recommendations on diagnosis and antibody testing. J Neuroinflammation. 2018 May 3;15(1):134. doi: 10.1186/s12974-018-1144-2.
PMID: 29724224
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: doaa mokhtar mahmoud
investigator title: Principal Investigator
mesh term: Neuromyelitis Optica
mesh term: Antibodies
mesh term: Immunoglobulins
sharing ipd: Undecided