drugset / Trial / NCT02976766

Adjunctive Gypenosides for Acute Optic Neuritis

NCT02976766 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2017-02-04
Primary completion
2018-07-30
Completion
2018-07-30

Outcome

Missed primary endpoint

Stopped (Enrollment): “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.”

paper did not meet the pRNFL primary endpoint. PMID 42398278 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gypenosides Unknown 60 mg Oral

Indications