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

• Sponsor: First Affiliated Hospital of Guangxi Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05540262
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 27.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Edaravone showed a good effect on promoting remyelination and protecting axons in NMOSD animals. The investigators hypothesize that edaravone can inhibit axonal damage in patients with aquaporin-4 antibody-positive optic neuritis.

Condition or Disease	Intervention/Treatment	Phase
Optic Neuritis	Drug: Edaravone	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Edaravone in the Treatment of Aquaporin-4 Antibody-positive Optic Neuritis
• Anticipated Study Start Date: Sep 15, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Edaravone	Drug: Edaravone; Edaravone injection 30mg three times a day

Outcome Measures

Primary Outcome Measures

1. Best-corrected visual acuity [18 months]

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

Secondary Outcome Measures

1. Ganglion cell-inner plexiform layer [18 months]

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

2. Peripapillary retinal nerve fiber layer [18 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yi Du	Nanning		China	530021

Sponsors and Collaborators

• First Affiliated Hospital of Guangxi Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yi Du, Dr., First Affiliated Hospital of Guangxi Medical University
• ClinicalTrials.gov Identifier: NCT05540262
• Other Study ID Numbers: GXEDAON1.0
• First Posted: Sep 14, 2022
• Last Update Posted: Sep 15, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuritis; Optic Neuritis; Edaravone

Study Results

No Results Posted as of Sep 15, 2022