NCT05540262

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

September 11, 2022

Last Update Submit

February 25, 2025

Conditions

Optic Neuritis

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity

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

    18 months

Secondary Outcomes (2)

  • Ganglion cell-inner plexiform layer

    18 months

  • Peripapillary retinal nerve fiber layer

    18 months

Study Arms (1)

Edaravone

EXPERIMENTAL
Drug: Edaravone

Interventions

EdaravoneDRUG

Edaravone injection 30mg three times a day

Edaravone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Myopia over 6 diopters
  • Refractive media opacity affecting assessment of retinal layers and/or visual acuity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yi Du

Nanning, 530021, China

RECRUITING

MeSH Terms

Conditions

Optic Neuritis

Interventions

Edaravone

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

AntipyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 11, 2022

First Posted

September 14, 2022

Study Start

January 15, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations

CN(1)