Recruiting

Observational Study

Sponsor:

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

Code:

NCT05605951

Conditions

Demyelinating Diseases

Multiple Sclerosis

Neuromyelitis Optica Spectrum Disorder Attack

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Optic Neuritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

non-interventional study

Study Details

Brief 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

Study ID

NCT05605951

Start date

Aug 15, 2020

Status verified date

Oct, 2022

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • First-ever acute ON
  • Onset of visual symptoms within maximum of 30 days
  • Age ≥ 18 years
  • Ability to give written informed consent
  • Presence of written consent

Exclusion Criteria:

  • MRI contraindication
  • Prior demyelinating diagnosis
  • Diagnosis of other forms of optic neuropathy (hereditary, granulomatous, infectious, infiltrative, toxic)
  • Pregnancy at inclusion
  • Relevant other diseases that conflict with study participation according to protocol
  • Inability to cooperate

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

non-interventional study

observational study

Primary outcome measure

  • to investigate whether MS-ON, AQP4-IgG+ON and MOG-IgG+ON patients treated with early high-dose corticosteroids for visual loss have better visual outcomes and QoL than those with late treatment. [ Time Frame: Six months follow-up ]

Central Contacts and Locations

Central contacts

Susanna Asseyer, Dr. med.

030450639727susanna.asseyer@charite.de

Hadas Stiebel-Kalish, Prof.

kalishhadas@gmail.com

Locations

Departments of Neurology and Ophthalmology, Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Principal Investigator:

Sean Pittock, Prof.

More Information

Sponsor

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

Last update posted

Nov 4, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul on 2022-11-04.