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

NCT ID: NCT02939937

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2019-01-02

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

phenytoin

patients received phenytoin 100mg three time daily up to 3 months

Group Type: EXPERIMENTAL

Phenytoin

Intervention Type: DRUG

100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.

placebo

patients received placebo 100 mg three time daily for 3 months

Group Type: EXPERIMENTAL

placebo

Intervention Type: DRUG

100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.

Interventions

Phenytoin

100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.

Intervention Type: DRUG

placebo

100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.

Intervention Type: DRUG

Other Intervention Names

epanutin

Eligibility Criteria

Inclusion Criteria

• isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist)
• willing to receive a steroidal regimen
• no pathologic finding in first oct
• no pathology and history of optic neuritis in contralateral eye
• <14 days since onset visual loss

Exclusion Criteria

• Contraindication or known allergy to Phenytoin
• Use of a calcium channel or sodium channel blocker in the past 2 months
• Corticosteroid use in the past 2 months
• Pregnancy
• Significant cardiac, renal or liver abnormalities
• Prior clinical episode of optic neuritis in either eye
• Bilateral acute optic neuritis
• Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
• Refractive error of greater than +5 or -5 diopters
• Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eye Research Center Farabi Hosoital

Tehran, , Iran

Countries

Iran

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

9411257013

Identifier Type: -

Identifier Source: org_study_id