Adjunctive Gypenosides for Acute Optic Neuritis

Adjunctive Gypenosides for Acute Optic Neuritis: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

Stopped earlyPhase 2Optic neuritisNCT02976766

What it found

Stopped: not working

The trial was stopped early because the treatment was not working.

Reason given: Slow recruitment and an unexpectedly high proportion of AQP4-IgG-positive optic neuritis on masked feasibility review limited feasibility. No interim efficacy analysis was performed.

What was tested

Treatment tested

  • Gypenosides

Placebo

  • Placebo

What it measured

Main measures

  • Mean peripapillary retinal nerve fiber layer thickness

    6 months

    Retina scans (OCT)Vision

Other measures (5)

  • Total macular volume

    6 months

    Retina scans (OCT)

  • Best-corrected visual acuity

    6 months

    Vision

  • Latency and amplitude of visual evoked potentials

    6 months

    Myelin repair

  • Mean visual field defect

    6 months

  • Number of participants with adverse events

    Screening until end of study

    Safety

Who could take part

Optic neuritis · 18 to 60

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This pilot randomized, double-blind, placebo-controlled trial evaluated whether short-course adjunctive gypenosides, added to standard corticosteroid treatment, may preserve retinal structural outcomes in adults with acute optic neuritis.

Papers

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History

    1. Started

      Feb 2017

    2. Main results due

      Jul 2018

    3. Finished

      Jul 2018

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