Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02939937
Recruitment Status : Completed
First Posted : October 20, 2016
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Optic Neuritis Drug: Phenytoin Drug: placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: participant , investigator
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 9, 2017
Actual Primary Completion Date : November 11, 2018
Actual Study Completion Date : January 2, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: phenytoin
patients received phenytoin 100mg three time daily up to 3 months
 Drug: Phenytoin
100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
Other Name: epanutin
Experimental: placebo
patients received placebo 100 mg three time daily for 3 months
 Drug: placebo
100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Retinal Ganglion Cell Inner Plexiform Layer Thickness [ Time Frame: Measured at baseline and month 1, 6 ]
    ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography

  2. Macular Layer Thickness [ Time Frame: Measured at baseline and month 1, 6 ]
    macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography

  3. Best Corrected Visual Acuity [ Time Frame: at baseline and month 6 ]
    Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.

  4. Visual Field Mean Deviation in Decibel [ Time Frame: Measured at baseline and month 6 ]
    The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).


Secondary Outcome Measures :
  1. Retinal Nerve Fibre Layer Thickness in Micrometer [ Time Frame: Measured at baseline and month1 ,6 ]
    Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939937


Locations
Layout table for location information
Iran, Islamic Republic of
Eye Research Center Farabi Hosoital
Tehran, Iran, Islamic Republic of, 3542168325
Sponsors and Collaborators
Tehran University of Medical Sciences
  Study Documents (Full-Text)

Documents provided by Tehran University of Medical Sciences:
Study Protocol  [PDF] April 14, 2019
Informed Consent Form  [PDF] April 15, 2019
Statistical Analysis Plan  [PDF] July 5, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02939937    
Other Study ID Numbers: 9411257013
First Posted: October 20, 2016    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
 Phenytoin
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers