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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05605951
Other study ID # ACON2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2020
Est. completion date December 31, 2025

Study information

Verified date October 2022
Source Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul
Contact Susanna Asseyer, Dr. med.
Phone 030450639727
Email susanna.asseyer@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
non-interventional study
observational study

Locations

Country Name City State
Argentina Hospital Aleman Buenos Aires
Australia Department of Neurology, Concord Hospital, Faculty of Medicine and Health Sydney
Botswana University of Botswana Gaborone
Brazil Federal University of Minas Gerais, Belo Horizonte Minas Gerais
Colombia Del Rosario University Bogotá
Colombia Department of Ophthalmology, Oftlamo-Sanitas Eye Institute, School of Medicine, Fundación Universitaria Sanitas Bogotá
Colombia Pontificia Universidad Javeriana Bogotá
Denmark Department of Neurology, Slagelse, Institute for Health Research, University of Southern Denmark Odense
France (MIRCEM) Lyon Civil Hospices, France Lyon
Germany Experimental and Clinical Research Center, Charite´ - Universita¨tsmedizin Berlin, Germany, Department of Neurology Berlin
Germany Institute for Clinical Neuroimmunology, LMU Clinic of Ludwig-Maximilians Universität in Munich Munich
India Nitte University, Karnataka Mangalore
Israel Hadassah Hebrew University Jerusalem
Israel Sackler School of Medicine and Rabin Medical Center Tel Aviv
Italy University of Bologna Bologna
Italy University of Verona Verona
Japan Fukushima Medical University School of Medicine Fukushima
Korea, Republic of National Cancer Center, Seúl University Seúl
Spain University of Barcelona Barcelona
Spain Vall d'Hebron Barcelona Hospital Campus Barcelona
United Kingdom University Hospitals of Birmingham Birmingham
United Kingdom Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital Oxford
United States University of Colorado School of Medicine Aurora Colorado
United States Harvard Medical School Boston Massachusetts
United States Departments of Neurology and Ophthalmology, Mayo Clinic Rochester Minnesota
Zambia University Teaching Hospital in Lusaka Lusaka

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Zambia,  Argentina,  Australia,  Botswana,  Brazil,  Colombia,  Denmark,  France,  Germany,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Six months follow-up
Secondary Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment. RNFL Six months follow-up
Secondary Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment. MRI lesion score Six months follow-up
Secondary Visual and structural outcomes of acute ON in patients treated with high-dose corticosteroid-therapy versus plasmapheresis as first-line treatment. MRI lesion score 12 months follow-up
Secondary 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 12 months follow-up
Secondary 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) Acute stage (onset)
Secondary 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) Acute stage (onset)
Secondary 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) Six months follow-up
Secondary 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) Six months follow-up
Secondary 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) 12 months follow-up
Secondary 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) 12 months follow-up
Secondary 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 Acute stage (onset)
Secondary 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 Acute stage (onset)
Secondary 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 Six months follow-up
Secondary 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 12 months follow-up
Secondary Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD. pRNFL Acute stage (onset)
Secondary Diagnostic value of OCT markers (e.g. increased pRNFL) for diagnosis of MS, NMOSD, and MOGAD. pRNFL Six months follow-up
Secondary Prognostic value of OCT markers (e.g. increased pRNFL) for the visual outcome at 1-year follow-up. pRNFL 12 months follow-up
Secondary Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS. OCT markers Acute stage (onset)
Secondary Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS. OCT markers Six months follow-up
Secondary Diagnostic value of OCT markers for a conversion from acute ON to clinically definite MS. OCT markers 12 months follow-up
Secondary Diagnostic value of early clinical variables (i.e. visual loss and pain patterns). pain intensity Acute stage (onset)
Secondary Diagnostic value of early clinical variables (i.e. visual loss and pain patterns). pain intensity Six months follow-up
Secondary Diagnostic value of early clinical variables (i.e. visual loss and pain patterns). pain intensity 12 months follow-up
Secondary Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. NEI-VFQ-Score Six months follow-up
Secondary Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. NEI-VFQ-Score 12 months follow-up
Secondary Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. BDI-II Score Six months follow-up
Secondary Characterization of visual function in daily routine, visual QoL scores and incidence of depression at 1-year follow-up. BDI-II Score 12 months follow-up
Secondary 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 Six months follow-up
Secondary 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 12 months follow-up
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