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

NCT02939937 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2019-08-12

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2018-11-11
Completion
2019-01-02

Countries

  • Iran

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02939937 on ClinicalTrials.gov