At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 44 enrolled
Drug / intervention
Glatiramer Acetate +1 moredrug
Likely dose
Glatiramer Acetate 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Mar 6, 2009·Updated Feb 6, 2018
In Brief
A Phase 3 clinical trial evaluating Glatiramer Acetate and placebo for Optic Neuritis. Completed, enrolled 44 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOptic Neuritis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedMar 2009
Primary CompletionDec 2010
Study CompletionFeb 2011
TodayJul 2026
First PostedMar 6, 2009
Enrollment StartFeb 1, 2009
Primary CompletionDec 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.3 years ago
Interventions
Glatiramer Acetatedrug
20 mg injected daily subcutaneously
placebodrug
injected daily subcutaneously