NCT02939937

Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Optic Neuritis

Interventions

Type	Name	Description
DRUG	Phenytoin	100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
DRUG	placebo	100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.

Timeline

• Start date: 2017-03-09
• Primary completion: 2018-11-11
• Completion: 2019-01-02
• First posted: 2016-10-20
• Last updated: 2019-08-12
• Results posted: 2019-08-12

Locations

1 site across 1 country: Iran