ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 104 for:    PHENYTOIN

Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer and Visual Field in Patients With an Acute 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 : Unknown
Verified August 2016 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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) and Visual Field in Patients With a First Episode of Acute Optic Neuritis
Study Start Date : July 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Retinal ganglion cell inner plexiform layer thickness in micrometer [ Time Frame: Measured at baseline ]
  2. Retinal ganglion cell inner plexiform layer thickness in micrometer [ Time Frame: Measured after 1 month of treatment ]
  3. Retinal ganglion cell inner plexiform layer thickness in micrometer [ Time Frame: Measured after 6 months of treatment ]

Secondary Outcome Measures :
  1. Visual field mean deviation in decibel [ Time Frame: Measured at baseline ]
  2. Visual field mean deviation in decibel [ Time Frame: Measured at 1 month ]
  3. Visual field mean deviation in decibel [ Time Frame: Measured at 6 months ]
  4. Retinal nerve fibre layer thickness in micrometer [ Time Frame: Measured at baseline ]
  5. Retinal nerve fibre layer thickness in micrometer [ Time Frame: Measured at 1 month ]
  6. Retinal nerve fibre layer thickness in micrometer [ Time Frame: Measured at 6 months ]


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.


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

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


Contacts
Contact: masoud aghsai fard, assisstant 09127934689 masood219@gmail.com

Locations
Iran, Islamic Republic of
Eye Research Center Farabi Hosoital Recruiting
Tehran, Iran, Islamic Republic of, 3542168325
Contact: alireza gholizade, resident    989112550646    a.gholizade13@yahoo.com   
Sponsors and Collaborators
Tehran University of Medical Sciences

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02939937     History of Changes
Other Study ID Numbers: 9411257013
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Phenytoin
Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
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