Clinical trial

Edaravone in the Treatment of Aquaporin-4 Antibody-positive Optic Neuritis

Name

GXEDAON1.0

Description

Edaravone has demonstrated a beneficial effect in promoting remyelination and protecting axons in animals with NMOSD. The researchers posit that edaravone may enhance visual outcomes in patients with aquaporin-4 antibody-positive optic neuritis.

Trial arms

Trial start

2022-01-15

Estimated PCD

2024-12-31

Trial end

2024-12-31

Status

Recruiting

Treatment

Edaravone

Edaravone injection 30mg three times a day

Arms:

Edaravone

Size

Primary endpoint

Best-corrected visual acuity

18 months

Eligibility criteria

Inclusion Criteria: 1. Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis 2. Patients with a first episode of optic neuritis in either eye 3. First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone Exclusion Criteria: 1. Myopia over 6 diopters 2. Refractive media opacity affecting assessment of retinal layers and/or visual acuity

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}

Updated at

2024-02-23

1 organization

1 product

1 indication

Organization

First Affiliated Hospital of Guangxi Medical University

Product

Edaravone

Indication

optic neuritis