drugset / Trial / NCT00856635

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)

NCT00856635

Phase 3 Completed 44 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.

Timeline

Start
2009-02
Primary completion
2010-12
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Glatiramer Acetate Small molecule 20 mg Subcutaneous

Indications