Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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

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
Area Under the Curve from 0 to 3 weeks (AUC0-3 weeks) of Sotatercept
Timepoint [1] 0 0
Predose Day 1, Day 7, Day 14, and Predose Day 21
Primary outcome [2] 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 [2] 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

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)

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/study/NCT05605951
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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/study/NCT05605951