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AzTrials

MS (Multiple Sclerosis)NCT07304960

Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder

An observational study of MS (Multiple Sclerosis) and NMO Spectrum Disorder (NMOSD), run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 50 years
How many people
100 participants
Where
No sites listed yet
Study dates
1 Jan 2026to 22 Dec 2030
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Adult

Study population: Patients attending toassuit hospitals

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hussein Abdelrahem Hussein, resident contact

0201151220581

hussein.17289842@med.aun.eg

Eman Mohamed Hussein, professor contact

020 10 05850632

emankhedr99@aun.edu.eg

About this study

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

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

Medical subject headings
Multiple Sclerosis, Neuromyelitis Optica

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline

Secondary outcomes (4)

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

    Correlation (Pearson or Spearman) between biomarker levels and total T2 lesion count at baseline MRI.

    Measured: Baseline

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

    Correlation analysis (Pearson or Spearman depending on distribution) between baseline serum concentrations of sGFAP/sNfL and baseline EDSS scores.

    Measured: Baseline

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

    Correlation between sGFAP/sNfL levels and MRI-measured optic nerve lesion length, including presence of longitudinally extensive transverse myelitis (LETM).

    Measured: Baseline

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

    Assessment of diagnostic accuracy using Area Under the Receiver Operating Characteristic Curve (AUC) for:

    1. sGFAP alone
    2. Combined biomarker model (sGFAP + sNfL)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion22 Dec 2030 (estimated)
  4. Study completion22 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07304960
Sponsor's protocol ID
MS VS NMO-2026
Status last verified
Dec 2025
First submitted
27 Nov 2025
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.

    PubMed 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/WNL.0000000000001729. Epub 2015 Jun 19.

    PubMed 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 of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.

    PubMed 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 Subcommittee of the American Academy of Neurology. Neurology. 2018 Apr 24;90(17):777-788. doi: 10.1212/WNL.0000000000005347.

    PubMed 29686116

Questions about this trial

What is this clinical trial studying?

An observational study of MS (Multiple Sclerosis) and NMO Spectrum Disorder (NMOSD), run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hussein Abdelrahem Hussein, resident (0201151220581, hussein.17289842@med.aun.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

serum Glial Fibrillary Acidic Protein levels (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07304960, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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