Optic NeuritisNCT05540262
Edaravone in the Treatment of Optic Neuritis
A study testing Edaravone in people with Optic Neuritis, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Edaravone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis
- Patients with a first episode of optic neuritis in either eye
- First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone
Who cannot join
- Myopia over 6 diopters
- Refractive media opacity affecting assessment of retinal layers and/or visual acuity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yi Du
Nanning, 530021
Yi Du, MD, +86 771 5356507, duyinapoleon@gmail.com
About this study
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.
- Conditions
- Optic Neuritis
- Being tested
- Edaravone
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdaravoneDrug
Edaravone injection 30mg three times a day
| Study group | Role | What they receive |
|---|---|---|
| Edaravone | Experimental | Not described Receives: Drug: Edaravone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
Best-corrected visual acuity will be measured by "Illiterate E"chart.
Measured: 18 months
Secondary outcomes (2)
Ganglion cell-inner plexiform layer
Ganglion cell-inner plexiform layer will be measured by optical coherence tomography.
Measured: 18 months
Peripapillary retinal nerve fiber layer
Peripapillary retinal nerve fiber layer will be measured by optical coherence tomography.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start15 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Du, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540262
- Sponsor's protocol ID
- GXEDAON1.0
- Status last verified
- Feb 2025
- First submitted
- 11 Sep 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edaravone in the Treatment of Optic Neuritis
- ClinicalTrials.gov ID
- NCT05540262
- Acronym / sponsor ID
- GXEDAON1.0
- Conditions
- Optic Neuritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edaravone | Experimental | Drug: Edaravone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis
- Patients with a first episode of optic neuritis in either eye
- First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone
Key exclusion criteria (2 listed)
- Myopia over 6 diopters
- Refractive media opacity affecting assessment of retinal layers and/or visual acuity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdaravoneEdaravone injection 30mg three times a day | Drug | Edaravone |
Primary outcome
Best-corrected visual acuity
Time frame: 18 months
Best-corrected visual acuity will be measured by "Illiterate E"chart.
2 secondary outcomes
Ganglion cell-inner plexiform layer
Time frame: 18 months
Peripapillary retinal nerve fiber layer
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edaravone in people with Optic Neuritis, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.