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Not yet recruiting NCT07304960

Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: MS (Multiple Sclerosis), NMO Spectrum Disorder (NMOSD). Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Study Between Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder Patients in Assiut Hospitals Clinical and Laboratory Study

Overview

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

Primary outcome measures

  • serum Glial Fibrillary Acidic Protein levels [Time frame: Baseline]
Secondary outcome measures (4)
  • Correlation between serum biomarkers (sGFAP and sNfL) and lesion burden on MRI. [Time frame: Baseline]
  • Correlation between serum biomarkers (sGFAP and sNfL) and Expanded Disability Status Scale (EDSS). [Time frame: Baseline]
  • Association between serum biomarkers and optic nerve involvement (length and presence of LETM). [Time frame: Baseline]
  • Diagnostic performance of sGFAP and combined sGFAP + sNfL in differentiating NMOSD from MS. [Time frame: Baseline]

Eligibility criteria

Inclusion Criteria:1- Both sex 2- Aged between 18 and 50 years. All included patients were in a clinically stable phase and had not experienced a relapse within at least three months before blood sampling. 3- All patients diagnosed as MS patients either naive or on disease modifying therapies according to The new diagnostic criteria MacDonalds 2024 4- DMT-naïve NMOSD patients: Diagnosed with MS based on the 2017 McDonald Criteria (Thompson et al., 2018)

5- An informed consent will be obtained from all the patients; the study will be approved by ethical committee in faculty of Medicine Assiut University

\-

1\_ 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

Exclusion criteria

  • 1\_ 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 mult PMID 24871874
  • 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 PMID 26092914
  • 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 PMID 29275977
  • 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 S PMID 29686116

Identifiers

NCT: NCT07304960 · MS VS NMO-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗