Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder

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

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Key information

Conditions

MS (Multiple Sclerosis) Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Multiple Sclerosis Myelitis, Transverse NMO Spectrum Disorder (NMOSD) Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

serum Glial Fibrillary Acidic Protein levels

Time frame: Baseline

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).

Secondary outcomes

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

Time frame: Baseline

Correlation (Pearson or Spearman) between biomarker levels and total T2 lesion count at baseline MRI.
Correlation between serum biomarkers (sGFAP and sNfL) and Expanded Disability Status Scale (EDSS).

Time frame: Baseline

Correlation analysis (Pearson or Spearman depending on distribution) between baseline serum concentrations of sGFAP/sNfL and baseline EDSS scores.
Association between serum biomarkers and optic nerve involvement (length and presence of LETM).

Time frame: Baseline

Correlation between sGFAP/sNfL levels and MRI-measured optic nerve lesion length, including presence of longitudinally extensive transverse myelitis (LETM).
Diagnostic performance of sGFAP and combined sGFAP + sNfL in differentiating NMOSD from MS.

Time frame: Baseline
Assessment of diagnostic accuracy using Area Under the Receiver Operating Characteristic Curve (AUC) for:
- sGFAP alone
- Combined biomarker model (sGFAP + sNfL)

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Mohamed Hussein, professor

CONTACT

[email protected]

020 10 05850632

Hussein Abdelrahem Hussein, resident

CONTACT

[email protected]

0201151220581

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Dec 26, 2025
Registry last updated: Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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