Clinical Trials Directory

Trials / Completed

CompletedNCT03819413

Clinical Patterns of Neuromyelitis Optica Spectrum Disorders in Assiut University Hospital

Status
Completed
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
3 Years – 75 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTserum 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_TESTserum 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_TESTMRI brain, spine and orbitAll patients suspected to have NMOSD according to the recent diagnostic criteria will have MRI brain, spine and orbit with Gadolinium

Timeline

Start date
2019-02-15
Primary completion
2020-07-15
Completion
2020-08-30
First posted
2019-01-28
Last updated
2020-11-06

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03819413. Inclusion in this directory is not an endorsement.