Trial reportNeurology2025
Effects of Phenytoin on the Retinal Ganglion Cell-Inner Plexiform Layer in Acute Optic Neuritis: Analysis of a Phase II Randomized Trial.
Trial report in Neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01451593 (A Phase II Double Blind, Randomized, Placebo Controlled Trial of Neuroprotection With Phenytoin in Acute Optic Neuritis), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Double Blind, Randomized, Placebo Controlled Trial of Neuroprotection With Phenytoin in Acute Optic Neuritis
Who cites it
1 citing paper in PubMed.
- Myelin Repair as a Neuroprotective Strategy for Multiple Sclerosis: From Bench to Bedside.Medicina (Kaunas, Lithuania) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesAcute demyelinating optic neuritis (AON) can lead to irreversible neuroaxonal loss. We investigated the neuroprotective effects of phenytoin on macular ganglion cell-inner plexiform layer (mGCIPL) thickness.
methodsWe reanalyzed Spectralis optical coherence tomography scans from the phenytoin AON trial (NCT01451593), a randomized, placebo-controlled, double-blind phase 2 trial. Participants attended 2 trial centers in London or Sheffield, United Kingdom. Patients with unilateral AON, age 18-60 years, within 2 weeks of onset, with visual acuities 6/9 or worse, were randomly assigned (1:1) to oral phenytoin (4-6 mg/kg/d) or placebo for 3 months, stratified by onset time, center, previous multiple sclerosis diagnosis, disease-modifying treatment, and corticosteroid use. Macular ganglion cell-inner plexiform layer thicknesses were extracted at baseline and 6 months. Linear regression models evaluated treatment effects on 6-month affected eye mGCIPL, adjusting for 6-month full-field visual evoked potential (VEP) latency and amplitude and baseline variables including mGCIPL thicknesses, steroid use, baseline acuity, and time interval to treatment. We also compared neuroprotective effects between peripapillary retinal nerve fiber layer (pRNFL) and mGCIPL outcomes.
resultsEighty patients (39 phenytoin: 41 placebo) with a mean age of 33.59 years, 70% female, participated in this study. At 6 months, significant treatment effects were estimated for phenytoin vs placebo (affected eye mGCIPL thicker by 6.79 μm, DISCUSSION: This study supports superiority of the mGCIPL over the pRNFL as a neuroprotective marker after AON and demonstrates strong associations with myelination, providing additional mechanistic insights. TRIAL REGISTRATION INFORMATION: This trial is registered with ClinicalTrials.gov, number NCT01451593; submitted for registration on October 11, 2011; first patient enrollment was on February 2, 2012. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that compared with placebo, phenytoin is associated with greater preservation of the mGCIPL thickness in patients with acute demyelinating optic neuropathy.
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