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

NCT02939937 | Completed Phase 2 Results DMC

• 1 other identifier: 9411257013
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Retinal Ganglion Cell Inner Plexiform Layer Thickness

  ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography

  Measured at baseline and month 1, 6

• Macular Layer Thickness

  macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography

  Measured at baseline and month 1, 6

• Best Corrected Visual Acuity

  Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.

  at baseline and month 6

• Visual Field Mean Deviation in Decibel

  The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).

  Measured at baseline and month 6

Secondary Outcomes (1)

• Retinal Nerve Fibre Layer Thickness in Micrometer

  Measured at baseline and month1 ,6

Study Arms (2)

phenytoin

EXPERIMENTAL

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

Drug: Phenytoin

placebo

EXPERIMENTAL

patients received placebo 100 mg three time daily for 3 months

Drug: placebo

Interventions

Phenytoin DRUG

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

Also known as: epanutin

phenytoin

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Eye Research Center Farabi Hosoital

Tehran, 3542168325, Iran

Location

MeSH Terms

Conditions

Optic Neuritis

Interventions

Phenytoin

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

1. Shorter follow up 2. Poor compliance for oral drug intake

Results Point of Contact

• Title: dr.alireza gholizade
• Organization: assistant

a.gholizade13@yahoo.com

989112550646

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participant , investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: October 20, 2016
• Study Start: March 9, 2017
• Primary Completion: November 11, 2018
• Study Completion: January 2, 2019
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IR (1)