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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05605951