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Subcutaneous Trigeminal Nerve Field Stimulation for Refractory Facial Pain
Published on: May 10, 2017
IV Fosphenytoin for Acute Trigeminal Neuralgia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Shusaku Noro1, Toru Hatayama2, Yoshiyasu Iwai3
1Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo, Japan.
Neurology
|May 7, 2026
Summary
Intravenous fosphenytoin therapy (IFT) significantly reduced pain in patients experiencing acute trigeminal neuralgia (TN) exacerbations. This rapid-acting treatment was well-tolerated and may offer a viable short-term option for TN pain relief.
Area of Science:
- Neurology
- Pharmacology
- Clinical Trials
Background:
- Trigeminal neuralgia (TN) causes severe facial pain, with limited options for acute exacerbations.
- Oral medications are often insufficient, and surgical interventions are not immediate solutions.
- Intravenous (IV) medications for acute TN exacerbations lack randomized controlled trial (RCT) investigation.
Purpose of the Study:
- To evaluate the efficacy and safety of IV fosphenytoin therapy (IFT) as a rescue treatment for acute TN exacerbations.
- To test the hypothesis that IFT reduces acute TN pain compared to placebo.
Main Methods:
- A multicenter, double-blind, placebo-controlled phase 3 RCT involving patients with TN exacerbation (NRS score ≥5).
- Participants received either IFT or placebo, with pain scores assessed up to 120 minutes post-initial dose.
- Primary endpoint: change in Numerical Rating Scale (NRS) pain scores; secondary endpoints included attack frequency and pain improvement.
Main Results:
- IFT significantly reduced pain scores compared to placebo (NRS change: -6.1 vs -2.4; p=0.008).
- IFT decreased 24-hour attack frequency and increased the proportion of patients achieving ≥50% NRS improvement (90.9% vs 40.0%).
- Adverse events, including somnolence, hypotension, and nausea, were mild and transient.
Conclusions:
- IFT demonstrated rapid and well-tolerated pain relief for acute TN exacerbations.
- Preliminary findings suggest IFT as a potential short-term treatment option for TN.
- Further investigation is warranted due to the study's small sample size.
