An observational study in Demyelinating Diseases, Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder Attack, sponsored by Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul. Recruiting at 26 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul · Observational
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:
The Acute Optic Neuritis Network (ACON) is a global cooperation of currently 26 academic centers longitudinally investigating subjects with inaugural acute optic neuritis (ON). ON often occurs at presentation of multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and myelin-oligodendrocyte-glycoprotein (MOG) antibody-associated disease (MOGAD). The recommended treatment of high-dose corticosteroids for ON is based on a North-American study population, which did not address treatment timing, or antibody serostatus. The ACON study is primarily designed to investigate the effect of time to high-dose corticosteroid treatment on 6-month visual outcomes in ON.
All patients presenting within 30 days of inaugural ON will be enrolled. For primary analysis, patients will subsequently be assigned either into the MS-ON, aquaporin-4-IgG positive ON (AQP4-IgG+ON) or MOG-IgG positive ON (MOG-IgG+ON) group and then further sub-stratified according to the number of days from onset of visual loss to high-dose corticosteroids. The primary outcome measure will be high-contrast best-corrected visual acuity (HC-BCVA) at 6 months. Additionally, multimodal data will be collected in subjects with any ON (CIS-ON, MS-ON, AQP4-IgG+ON or MOG-IgG+ON and seronegative non-MS-ON), excluding infectious and granulomatous ON. Secondary outcomes include: optical coherence tomography (OCT) and magnetic resonance imaging (MRI) measurements, serum and cerebrospinal fluid (CSF) biomarkers (AQP4- and MOG-IgG levels; neurofilament; glial fibrillary protein), questionnaires (headache, visual function in daily routine, depression, and quality of life) at presentation, at 6- and 12-months follow-up. Data will be collected from 22 academic hospitals from Africa, Asia, the Middle East, Europe, North America, South America, Australia and Europe. Planned recruitment consists of 100 MS-ON, 50 AQP4-IgG+ON and 50 MOG-IgG+ON.
This prospective, multimodal data collection will assess the potential value of early high-dose corticosteroid treatment, investigate the interrelations between functional impairments and structural changes, and evaluate the diagnostic yield of laboratory biomarkers. This analysis has the ability to substantially improve treatment strategies and accuracy of diagnostic stratification in acute demyelinating ON.
103 studies on the registry are indexed under Demyelinating Diseases; 25 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 30 observational studies indexed under Demyelinating Diseases.
Browse Demyelinating Diseases studies →This is the only study on the registry with Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul as lead sponsor.
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At least 300 patients with acute ON will be screened for study eligibility. We will include only inaugural ON patients. Subjects presenting for the first time with isolated ON or ON with additional demyelinating syndromes, e.g. myelitis or acute disseminated encephalomyelitis (ADEM) occurring within 30 days of the acute ON will be included. Patients with prior soft symptoms which can retrospectively be considered to be a demyelinating manifestation will be included, excluding patients with a prior demyelinating diagnosis. The prevalence of MS-, AQP4-IgG+ON and MOG-IgG+ON differs in each of the participating centers. For primary analysis, we collect data from subjects with MS-ON, AQP4-IgG+ON and MOG-IgG+ON. For secondary analysis, multimodal data will be collected in subjects with any demyelinating ON (CIS-ON, MS-ON, AQP4-IgG+ON or MOG-IgG+ON and seronegative non-MS-ON). We expect between 30-50% will be ineligible due to the rigorous exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
observational study
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.
visual acuity
Time frame: Six months follow-up
Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.
RNFL
Time frame: Six months follow-up
Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.
MRI lesion score
Time frame: Six months follow-up
Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.
MRI lesion score
Time frame: 12 months follow-up
Visual and structural outcomes of MS-ON in patients treated with high-dose corticosteroid-therapy with oral prednisone taper vs. without taper as standard of care.
RNFL
Time frame: 12 months follow-up
Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.
NfL (pg/ml)
Time frame: Acute stage (onset)
Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.
GFAP (pg/ml)
Time frame: Acute stage (onset)
Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.
NfL (pg/ml)
Time frame: Six months follow-up
Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.
GFAP (pg/ml)
Time frame: Six months follow-up
Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.
NfL (pg/ml)
Time frame: 12 months follow-up
Diagnostic and prognostic value of biomarker levels (NfL, GFAP) and associations with visual pathway damage (MRI- and OCT-based) in the acute stage and during follow-up.
GFAP (pg/ml)
Time frame: 12 months follow-up
Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.
MOG-IgG ratio
Time frame: Acute stage (onset)
Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.
AQP4-IgG ratio
Time frame: Acute stage (onset)
Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.
MOG-IgG IgG ratio
Time frame: Six months follow-up
Characterization of MOG-IgG and AQP4-IgG levels and compartmentalisation (serum vs. CSF, using simultaneous paired samples) and associated risks for subsequent relapses in subjects with AQP4-IgG+ON and MOG-IgG+ON.
AQP4-IgG ratio
Time frame: 12 months follow-up
Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD.
pRNFL
Time frame: Acute stage (onset)
Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD.
pRNFL
Time frame: Six months follow-up
Prognostic value of OCT markers (e.g. increased pRNFL) for the visual outcome at 1-year follow-up.
pRNFL
Time frame: 12 months follow-up
Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.
OCT markers
Time frame: Acute stage (onset)
Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.
OCT markers
Time frame: Six months follow-up
Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.
OCT markers
Time frame: 12 months follow-up
Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).
pain intensity
Time frame: Acute stage (onset)
Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).
pain intensity
Time frame: Six months follow-up
Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).
pain intensity
Time frame: 12 months follow-up
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
NEI-VFQ-Score
Time frame: Six months follow-up
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
NEI-VFQ-Score
Time frame: 12 months follow-up
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
BDI-II Score
Time frame: Six months follow-up
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
BDI-II Score
Time frame: 12 months follow-up
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
EuroQol 5-Dimension EQ-5D-index
Time frame: Six months follow-up
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
EuroQol 5-Dimension EQ-5D-index
Time frame: 12 months follow-up
Plan to share: No — The datasets generated and/or analyzed during the current study are not publicly available but are available from the corresponding author upon reasonable request
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