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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05605951




Registration number
NCT05605951
Ethics application status
Date submitted
23/10/2022
Date registered
4/11/2022
Date last updated
4/11/2022

Titles & IDs
Public title
Acute Optic Neuritis Network: an International Study That Invesitages Subjects With a First-ever Episode of Acute Inflammation of the Optic Nerve
Scientific title
The Acute Optic Neuritis Network (ACON): a Non-interventional Prospective Multicenter Study on Diagnosis and Treatment of Acute Optic Neuritis
Secondary ID [1] 0 0
ACON2022
Universal Trial Number (UTN)
Trial acronym
ACON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Demyelinating Diseases 0 0
Multiple Sclerosis 0 0
Neuromyelitis Optica Spectrum Disorder Attack 0 0
Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease 0 0
Optic Neuritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Neurological 0 0 0 0
Other neurological disorders
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - non-interventional study

Other interventions: non-interventional study
observational study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Six months follow-up
Secondary outcome [1] 0 0
Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.
Timepoint [1] 0 0
Six months follow-up
Secondary outcome [2] 0 0
Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.
Timepoint [2] 0 0
Six months follow-up
Secondary outcome [3] 0 0
Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment.
Timepoint [3] 0 0
12 months follow-up
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
12 months follow-up
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Acute stage (onset)
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Acute stage (onset)
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Six months follow-up
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Six months follow-up
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
12 months follow-up
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
12 months follow-up
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Acute stage (onset)
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Acute stage (onset)
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Six months follow-up
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
12 months follow-up
Secondary outcome [15] 0 0
Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD.
Timepoint [15] 0 0
Acute stage (onset)
Secondary outcome [16] 0 0
Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD.
Timepoint [16] 0 0
Six months follow-up
Secondary outcome [17] 0 0
Prognostic value of OCT markers (e.g. increased pRNFL) for the visual outcome at 1-year follow-up.
Timepoint [17] 0 0
12 months follow-up
Secondary outcome [18] 0 0
Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.
Timepoint [18] 0 0
Acute stage (onset)
Secondary outcome [19] 0 0
Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.
Timepoint [19] 0 0
Six months follow-up
Secondary outcome [20] 0 0
Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS.
Timepoint [20] 0 0
12 months follow-up
Secondary outcome [21] 0 0
Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).
Timepoint [21] 0 0
Acute stage (onset)
Secondary outcome [22] 0 0
Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).
Timepoint [22] 0 0
Six months follow-up
Secondary outcome [23] 0 0
Diagnostic value of early clinical variables (i.e. visual loss and pain patterns).
Timepoint [23] 0 0
12 months follow-up
Secondary outcome [24] 0 0
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
Timepoint [24] 0 0
Six months follow-up
Secondary outcome [25] 0 0
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
Timepoint [25] 0 0
12 months follow-up
Secondary outcome [26] 0 0
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
Timepoint [26] 0 0
Six months follow-up
Secondary outcome [27] 0 0
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
Timepoint [27] 0 0
12 months follow-up
Secondary outcome [28] 0 0
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
Timepoint [28] 0 0
Six months follow-up
Secondary outcome [29] 0 0
Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up.
Timepoint [29] 0 0
12 months follow-up

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Neurology, Concord Hospital, Faculty of Medicine and Health - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Botswana
State/province [5] 0 0
Gaborone
Country [6] 0 0
Brazil
State/province [6] 0 0
Minas Gerais
Country [7] 0 0
Colombia
State/province [7] 0 0
Bogotá
Country [8] 0 0
Denmark
State/province [8] 0 0
Odense
Country [9] 0 0
France
State/province [9] 0 0
Lyon
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Munich
Country [12] 0 0
India
State/province [12] 0 0
Mangalore
Country [13] 0 0
Israel
State/province [13] 0 0
Jerusalem
Country [14] 0 0
Israel
State/province [14] 0 0
Tel Aviv
Country [15] 0 0
Italy
State/province [15] 0 0
Bologna
Country [16] 0 0
Italy
State/province [16] 0 0
Verona
Country [17] 0 0
Japan
State/province [17] 0 0
Fukushima
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seúl
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Birmingham
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Oxford
Country [22] 0 0
Zambia
State/province [22] 0 0
Lusaka

Funding & Sponsors
Primary sponsor type
Other
Name
Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05605951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susanna Asseyer
Address 0 0
Charite University, Berlin, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Susanna Asseyer, Dr. med.
Address 0 0
Country 0 0
Phone 0 0
030450639727
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05605951