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✓ Translated by DotMD AI Clinical Council Source: Neurology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #42096672 ↗

Phase III Randomized Trial: IV Fosphenytoin for Acute Trigeminal Neuralgia

Original Paper Title: “IV Fosphenytoin for Acute Trigeminal Neuralgia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Of 31 participants screened, 22 were randomized; 1 placebo-assigned participant did not meet the NRS ≥5 criterion and was excluded, leaving 21 for analysis (IFT: 11; placebo: 10). Participants had a mean age of 65.2 years (range 42-83; 8 men, 13 women).
  • Study Design & Sample: Phase III Randomized Trial published in Neurology (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Neurology (2026), this phase iii randomized trial evaluating human clinical outcomes investigated: Trigeminal neuralgia (TN) is a debilitating condition characterized by sudden, severe facial pain. Key clinical takeaway: Of 31 participants screened, 22 were randomized; 1 placebo-assigned participant did not meet the NRS ≥5 criterion and was excluded, leaving 21 for analysis (IFT: 11; placebo: 10). Participants had a mean age of 65.2 years (range 42-83; 8 men, 13 women).

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Neurology, 2026-06-09; Phase III Randomized Trial; Rigor 88/100): Of 31 participants screened, 22 were randomized; 1 placebo-assigned participant did not meet the NRS ≥5 criterion and was excluded, leaving 21 for analysis (IFT: 11; placebo: 10). Participants had a mean age of 65.2 years (range 42-83; 8 men, 13 women).

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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