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Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital

NCT ID: NCT03819413

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-15

Study Completion Date

2020-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neuromyelitis Optica Spectrum Disorder

Keywords

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Neuromyelitis Optica Spectrum Disorder prevalence anti-AQP4 anti-MOG

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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)

Intervention Type 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)

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

* An alternate diagnosis became apparent
* if no serum sample was supplied
* Subject declined to provide written informed consent.
Minimum Eligible Age

3 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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doaa mokhtar mahmoud

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noha A Abo Elfotoh, prof

Role: STUDY_DIRECTOR

Assuit university hospital

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Weinshenker BG, Wingerchuk DM. Neuromyelitis Spectrum Disorders. Mayo Clin Proc. 2017 Apr;92(4):663-679. doi: 10.1016/j.mayocp.2016.12.014.

Reference Type BACKGROUND
PMID: 28385199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25921037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15589308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29524760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28670343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30090123 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29724224 (View on PubMed)

Other Identifiers

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NMOSD In Assiut University

Identifier Type: -

Identifier Source: org_study_id