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Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital

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ClinicalTrials.gov Identifier: NCT03819413
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
doaa mokhtar mahmoud, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Neuromyelitis Optica Spectrum Disorder Diagnostic Test: serum aquaporin 4 antibody (AQP-4-Ab) Diagnostic Test: serum MOG antibody (anti-MOG) Diagnostic Test: MRI brain, spine and orbit

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020



Intervention Details:
  • Diagnostic Test: serum aquaporin 4 antibody (AQP-4-Ab)
    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)
  • Diagnostic Test: serum MOG antibody (anti-MOG)
    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)
  • Diagnostic Test: MRI brain, spine and orbit
    All patients suspected to have NMOSD according to the recent diagnostic criteria will have MRI brain, spine and orbit with Gadolinium


Primary Outcome Measures :
  1. the percentage of increase in NMOSD diagnostic rates by screening for serum anti-AQP4 and anti-MOG antibodies [ Time Frame: one year period ]
    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


Secondary Outcome Measures :
  1. percentage of patients were misdiagnosed as MS after screening for serum anti-AQP4 and anti-MOG antibodies [ Time Frame: one year period ]
    To measure the role of Serum anti-AQP4 and anti-MOG antibodies to differentiate suspicious cases from MS

  2. the percentage of increase of anti-MOG associated diseases after screening for serum anti-MOG antibodies [ Time Frame: one year period ]
    To assess the impact of screening for serum anti-MOG antibodies on diagnostic rates of anti-MOG associated diseases



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Ages Eligible for Study:   3 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients suspected to have NMOSD according to the recent diagnostic criteria attending or referred to Neurology and Psychiatry department of Assiut University hospital
Criteria

Inclusion Criteria:

  • All cases that fulfill the international 2015 consensus criteria of NMOSD
  • Any episode suggestive of idiopathic inflammatory demyelinating central nervous system disease including

    • longitudinally extensive transverse myelitis (LETM) or optic neuritis (ON) plus Cerebral or Brainstem syndrome (LETM or ON PLUS)
    • optic neuritis (ON)
    • longitudinally extensive transverse myelitis (LETM),
    • Transverse myelitis with non-extensive lesion (NETM)
    • Acute encephalomyelitis (ADEM).
  • Atypical MS cases (atypical clinical presentation, course, radiological findings or atypical response to treatment)
  • Age: all patients of both sexes and all age groups will be included.

Exclusion Criteria:

  • Inclusion criteria for suspected NMOSD were not met
  • An alternate diagnosis became apparent
  • if no serum sample was supplied
  • Subject declined to provide written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819413


Contacts
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Contact: Doaa M Mahmoud, Master's +201005308849 ext +2 doaamokhtarmahmoud@gmail.com
Contact: Ahmed N Mohammed, MD 01009949677 ext +2 d_ahmednasr@yahoo.com

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt, 71511
Contact: doaa m mahmoud    1005308849    doaamokhtarmahmoud@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Noha A Abo Elfotoh, prof Assuit university hospital

Additional Information:
Publications:

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Responsible Party: doaa mokhtar mahmoud, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03819413     History of Changes
Other Study ID Numbers: NMOSD In Assiut University
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by doaa mokhtar mahmoud, Assiut University:
Neuromyelitis Optica Spectrum Disorder
prevalence
anti-AQP4
anti-MOG
Additional relevant MeSH terms:
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Neuromyelitis Optica
Disease
Pathologic Processes
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs