Edaravone in the Treatment of Optic Neuritis | NCT05540262

Studies
Edaravone in the Treatment of Optic Neuritis

NCT05540262

Sponsor

First Affiliated Hospital of Guangxi Medical University

Status

Recruiting

Last Update Posted

Feb 27, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Optic Neuritis

Interventions

Edaravone

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Sep 11, 2022

First Submission Date that Met QC Criteria

Sep 11, 2022

First Posted Date

Sep 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2025

Last Update Posted Date

Feb 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yi Du, Dr., First Affiliated Hospital of Guangxi Medical UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Guangxi Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Edaravone	Experimental		Drug: Edaravone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Edaravone	Drug	Edaravone injection 30mg three times a day	Edaravone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best-corrected visual acuity	Best-corrected visual acuity will be measured by "Illiterate E"chart.	18 months

Secondary Outcomes

Measure	Description	Time Frame
Ganglion cell-inner plexiform layer	Ganglion cell-inner plexiform layer will be measured by optical coherence tomography.	18 months
Peripapillary retinal nerve fiber layer	Peripapillary retinal nerve fiber layer will be measured by optical coherence tomography.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Yi Du	Recruiting	Nanning		530021	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009902	Optic Neuritis

Ancestor Terms

ID	Term
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077553	Edaravone

Ancestor Terms

ID	Term
D000983	Antipyrine
D047069	Pyrazolones
D011720	Pyrazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided