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RecruitingNCT05540262Updated Feb 27, 2025

Edaravone in the Treatment of Optic Neuritis

An interventional study of Edaravone in Optic Neuritis, sponsored by First Affiliated Hospital of Guangxi Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by First Affiliated Hospital of Guangxi Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Jan 2022, registered Sep 2022).
  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Optic Neuritis

Browse trials for

03

In context

Optic Neuritis

88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 58 interventional studies indexed under Optic Neuritis.

Browse Optic Neuritis studies →

Lead sponsor

First Affiliated Hospital of Guangxi Medical University is the lead sponsor of 41 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Myopia over 6 diopters
  2. Refractive media opacity affecting assessment of retinal layers and/or visual acuity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Edaravone

    Drug: Edaravone

Interventions

  • DrugEdaravone

    Edaravone injection 30mg three times a day

06

What researchers measure

Primary outcomes

  1. Best-corrected visual acuity

    Best-corrected visual acuity will be measured by "Illiterate E"chart.

    Time frame: 18 months

Secondary outcomes

  1. Ganglion cell-inner plexiform layer

    Ganglion cell-inner plexiform layer will be measured by optical coherence tomography.

    Time frame: 18 months

  2. Peripapillary retinal nerve fiber layer

    Peripapillary retinal nerve fiber layer will be measured by optical coherence tomography.

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • Yi Du
    Nanning, 530021, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2022 (actual). Primary completion is estimated for Dec 2025, 47 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2022
First posted
Sep 14, 2022
StartActual
Jan 15, 2022
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Feb 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05540262
Lead sponsor
First Affiliated Hospital of Guangxi Medical University
Responsible party
Yi Du (Dr., First Affiliated Hospital of Guangxi Medical University) — Principal investigator
First posted
Sep 14, 2022
Start date
Jan 15, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Feb 27, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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