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Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07304960
Enrollment
100
Registered
2025-12-26
Start date
2026-01-01
Completion date
2030-12-22
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years

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

Design outcomes

Primary

MeasureTime frameDescription
serum Glial Fibrillary Acidic Protein levelsBaselineMeasurement 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

MeasureTime frameDescription
Correlation between serum biomarkers (sGFAP and sNfL) and lesion burden on MRI.BaselineCorrelation (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).BaselineCorrelation 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).BaselineCorrelation 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.BaselineAssessment of diagnostic accuracy using Area Under the Receiver Operating Characteristic Curve (AUC) for: 1. sGFAP alone 2. Combined biomarker model (sGFAP + sNfL)

Contacts

Primary ContactHussein Abdelrahem Hussein, resident
hussein.17289842@med.aun.eg0201151220581
Backup ContactEman Mohamed Hussein, professor
emankhedr99@aun.edu.eg020 10 05850632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026