Gypenosides Treatment for Optic Neuritis

Optic Neuritis Clinical Trial

Official title:

Gypenosides Treatment for Optic Neuritis: a Randomised, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02976766
• Other study ID #: GXON-001
• Status: Terminated
• Phase: Phase 2
• Start date: February 4, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: First Affiliated Hospital of Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether gypenosides are neuroprotective in patients with acute optic neuritis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria

1. Male and female Chinese patients aged =18 to =60 years

2. Patients with a first episode of optic neuritis in the eye of interest

3. First symptoms of optic neuritis =28 days prior to the first administration of investigational product

4. Best corrected visual acuity in the eye of interest =0.8 Exclusion criteria

1. Pre-existing multiple sclerosis MS or NMO

2. Refractive media opacity

3. Hyperopia >5 diopters, myopia <-5 diopters, or astigmatism >3 diopters

4. Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial

5. Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)

6. Existing other retina or optic nerve diseases

7. Pregnant or females who plan to be pregnant during study

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

Drug:
• Gypenosides
Participants will receive gypenosides 360 mg/day (120 mg three times a day) for 10 days.
• Placebo
Participants will receive placebo three times a day for 10 days.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean retinal nerve fibre layer thickness		6 months
Secondary	Total macular volume		6 months
Secondary	Best corrected visual acuity		6 months
Secondary	Latency and amplitude of visual evoked potentials		6 months
Secondary	Mean visual field defect		6 months
Secondary	Number of participants with Adverse events		Screening until end of study