Gypenosides Treatment for Optic Neuritis

NCT02976766 | Terminated Phase 2

• 1 other identifier: GXON-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Optic Neuritis

Keywords

Neuroprotection; Clinical trial; Traditional Chinese medicine; Axonal loss; Jiaogulan; Gynostemma pentaphyllum; Optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Mean retinal nerve fibre layer thickness

  6 months

Secondary Outcomes (5)

• Total macular volume

  6 months

• Best corrected visual acuity

  6 months

• Latency and amplitude of visual evoked potentials

  6 months

• Mean visual field defect

  6 months

• Number of participants with Adverse events

  Screening until end of study

Study Arms (2)

Gypenosides

EXPERIMENTAL

Drug: Gypenosides

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Gypenosides DRUG

Participants will receive gypenosides 180 mg/day (60 mg three times a day) for 10 days.

Also known as: Jiaogulan Zongdai

Gypenosides

Placebo DRUG

Participants will receive placebo three times a day for 10 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female Chinese patients aged ≥18 to ≤60 years
• Patients with a first episode of optic neuritis in the eye of interest
• First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product
• Best corrected visual acuity in the eye of interest ≤0.8

You may not qualify if:

• Pre-existing multiple sclerosis MS or NMO
• Refractive media opacity
• Hyperopia \>5 diopters, myopia \<-5 diopters, or astigmatism \>3 diopters
• Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial
• Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)
• Existing other retina or optic nerve diseases
• Pregnant or females who plan to be pregnant during study

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Optic Neuritis

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Yi Du, MD

  The First Affiliated Hospital of Guangxi Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: November 29, 2016
• Study Start: February 4, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CN (1)