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Acute Optic Neuritis Network: an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve

NCT05605951 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-11-04

No results posted yet for this study

Summary

The goal of this observational study is to longitudinally investigating subjects with inaugural acute optic neuritis (ON).

The main questions it aims to answer are:

* Does the time to corticosteroid treatment affect the visual outcome at 6 months in subjects with acute multiple sclerosis (MS)-, aquaporin 4-IgG positive (AQP4-IgG+) and myelin-oligodendrocyte-glycoprotein-IgG positive (MOG-IgG+) ON?
* How differ clinical, structural, and laboratory biomarkers in subjects with acute ON, including clinical isolated syndrome (CIS), MS-ON, AQP4-IgG+ON, MOG-IgG+ON and seronegative non-MS-ON? Participants will undergo
* clinical examination, including clinical history, neurovisual and neurological tests
* serum and cerebrospinal fluid examination
* optical coherence tomography (OCT)
* magnetic resonance imaging (MRI)
* assessment of depression, pain, quality of life through validated questionnaires Researchers will compare subjects with MS-ON, AQP4-IgG+ON, MOG-IgG+ON and other ON (CIS, seronegative non-MS-ON) to detect diagnostic and predictive markers for the disease course.

Conditions

  • Demyelinating Diseases
  • Multiple Sclerosis
  • Neuromyelitis Optica Spectrum Disorder Attack
  • Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
  • Optic Neuritis

Interventions

OTHER

non-interventional study

observational study

Sponsors & Collaborators

  • Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul

    lead OTHER

Principal Investigators

  • Susanna Asseyer · Charite University, Berlin, Germany

  • Hadas Stiebel-Kalish · Rabin Medical Center, Tel Aviv

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Botswana
  • Brazil
  • Colombia
  • Denmark
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Japan
  • South Korea
  • Spain
  • United Kingdom
  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05605951 on ClinicalTrials.gov