At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
a Phase II Double Blind, Randomized, Placebo Controlled Trial of Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer (GCIPL) Thickness and Visual Field in Patients With a First Episode of Acute Optic Neuritis
In Brief
A Phase 2 clinical trial evaluating Phenytoin and placebo for Optic Neuritis. Completed, enrolled 71 participants across 1 site.
Detailed Summary
Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days. As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision. There are a number of factors that contribute to nerve fibre damage including increased level of sodium, so blocking sodium entry could help to protect them against damage. The main objective of the study is determine whether phenytoin (which blocks sodium entry) can protect nerve fibre and improve final visual function after optic neuritis.
Study Details
Timeline
Interventions
100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.