Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Phenytoin
Sodium channel alpha subunit blocker
Placebo or sham
- placebo
Results by group
Retinal Ganglion Cell Inner Plexiform Layer Thickness
Measured at baseline and month 1, 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Phenytoin | 36.56 micron | 6.61 (Standard Deviation) | 15 |
| Placebo | 34.65 micron | 8.49 (Standard Deviation) | 47 |
| Phenytoin | 31 micron | 6.61 (Standard Deviation) | 15 |
| Placebo | 29.42 micron | 5.98 (Standard Deviation) | 47 |
| Phenytoin | 30.70 micron | 5.56 (Standard Deviation) | 15 |
| Placebo | 32.12 micron | 9.1 (Standard Deviation) | 47 |
Macular Layer Thickness
Measured at baseline and month 1, 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Phenytoin | 262.73 micron | 22.02 (Standard Deviation) | 15 |
| Placebo | 265.98 micron | 22.5 (Standard Deviation) | 47 |
| Phenytoin | 255 micron | 19.72 (Standard Deviation) | 15 |
| Placebo | 264.39 micron | 22.53 (Standard Deviation) | 47 |
| Phenytoin | 269 micron | 28.29 (Standard Deviation) | 15 |
| Placebo | 268.37 micron | 22.69 (Standard Deviation) | 47 |
Best Corrected Visual Acuity
at baseline and month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Phenytoin | 1.44 log mar | 0.98 (Standard Deviation) | 15 |
| Placebo | 1 log mar | 0.83 (Standard Deviation) | 47 |
| Phenytoin | 0.04 log mar | 0.067 (Standard Deviation) | 15 |
| Placebo | 0.13 log mar | 0.448 (Standard Deviation) | 47 |
Phenytoin
Placebo
Phenytoin
Placebo
Visual Field Mean Deviation in Decibel
Measured at baseline and month 6
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Phenytoin | -17.07 db | 11.41 (Standard Deviation) | 15 |
| Placebo | -17.76 db | 11.81 (Standard Deviation) | 47 |
| Phenytoin | -3.89 db | 4.46 (Standard Deviation) | 15 |
| Placebo | -5.16 db | 7.49 (Standard Deviation) | 47 |
Phenytoin
Placebo
Phenytoin
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Phenytoin | 21 | 1 (4.8%) | 0 |
| Placebo | 50 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Retinal Ganglion Cell Inner Plexiform Layer Thickness
Measured at baseline and month 1, 6
Retina scans (OCT)Macular Layer Thickness
Measured at baseline and month 1, 6
Retina scans (OCT)Best Corrected Visual Acuity
at baseline and month 6
VisionVisual Field Mean Deviation in Decibel
Measured at baseline and month 6
Other measures (1)
Retinal Nerve Fibre Layer Thickness in Micrometer
Measured at baseline and month1 ,6
Retina scans (OCT)
Who could take part
Optic neuritis · 18 to 60
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Mar 2017
Main results due
Nov 2018
Finished
Jan 2019
Results posted
Aug 2019
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