Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder

NCT07304960 | Not Yet Recruiting

• 1 other identifier: MS VS NMO-2026
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this work is to do a detailed comparison between multiple sclerosis and Neuromyelitis Optica Spectrum Disorder due to delicate similarities between both diseases and wide rang of management and follow up of the patients

Conditions

MS (Multiple Sclerosis); NMO Spectrum Disorder (NMOSD)

Outcome Measures

Primary Outcomes (1)

• serum Glial Fibrillary Acidic Protein levels

  Measurement of serum concentrations of Glial Fibrillary Acidic Protein at baseline using a validated immunoassay (e.g., single-molecule array \[Simoa\] assay). difference in serum Glial Fibrillary Acidic Protein levels between treatment-naïve NMOSD and treatment-naïve MS patientsexpressed in picograms per milliliter (pg/mL).

  Baseline

Secondary Outcomes (4)

• Correlation between serum biomarkers (sGFAP and sNfL) and lesion burden on MRI.

  Baseline

• Correlation between serum biomarkers (sGFAP and sNfL) and Expanded Disability Status Scale (EDSS).

  Baseline

• Association between serum biomarkers and optic nerve involvement (length and presence of LETM).

  Baseline

• Diagnostic performance of sGFAP and combined sGFAP + sNfL in differentiating NMOSD from MS.

  Baseline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending toassuit hospitals

You may qualify if:

• An informed consent will be obtained from all the patients; the study will be approved by ethical committee in faculty of Medicine Assiut University
• \_ Presence of other disorder that mimic MS or NMOSD 3\_ Patients failed to commit to the follow up visits and regular MRI scans 4\_ Patients refused to sign the written informed consent

You may not qualify if:

• \_ Presence of other disorder that mimic MS or NMOSD 3\_ Patients failed to commit to the follow up visits and regular MRI scans 4\_ Patients refused to sign the written informed consent

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.

  PMID: 24871874 RESULT

• Wingerchuk DM, Banwell B, Bennett JL, Cabre P, Carroll W, Chitnis T, de Seze J, Fujihara K, Greenberg B, Jacob A, Jarius S, Lana-Peixoto M, Levy M, Simon JH, Tenembaum S, Traboulsee AL, Waters P, Wellik KE, Weinshenker BG; International Panel for NMO Diagnosis. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015 Jul 14;85(2):177-89. doi: 10.1212/WNL.0000000000001729. Epub 2015 Jun 19.

  PMID: 26092914 RESULT

• Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.

  PMID: 29275977 RESULT

• Rae-Grant A, Day GS, Marrie RA, Rabinstein A, Cree BAC, Gronseth GS, Haboubi M, Halper J, Hosey JP, Jones DE, Lisak R, Pelletier D, Potrebic S, Sitcov C, Sommers R, Stachowiak J, Getchius TSD, Merillat SA, Pringsheim T. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Apr 24;90(17):777-788. doi: 10.1212/WNL.0000000000005347.

  PMID: 29686116 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Central Study Contacts

Hussein Abdelrahem Hussein, resident

CONTACT

0201151220581; hussein.17289842@med.aun.eg

Eman Mohamed Hussein, professor

CONTACT

020 10 05850632; emankhedr99@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 22, 2030
• Study Completion (Estimated): December 22, 2030
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share