Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia

Recruiting

• Conditions: Trigeminal Neuralgia

• Registration Number: NCT06851910
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief Summary

This prospective observational study evaluates the effectiveness and safety of intravenous lacosamide as a rescue treatment for acute pain in patients presenting to the emergency department with trigeminal neuralgia

Detailed Description

This study is a prospective observational investigation evaluating the effectiveness and safety of intravenous lacosamide as a rescue treatment for acute pain exacerbations in trigeminal neuralgia. The trial will be conducted at Hospital Universitari de Bellvitge over a two-year period, enrolling approximately 20 patients who present to the emergency department with acute TN pain and receive intravenous lacosamide based on the treating physician's discretion.

Trigeminal neuralgia is characterized by severe, paroxysmal facial pain, often resistant to conventional therapies. While sodium channel blockers such as carbamazepine and oxcarbazepine are first-line treatments, many patients experience refractory pain or unacceptable side effects. Evidence supporting intravenous options for acute exacerbations remains limited, with studies suggesting potential benefits of phenytoin, lidocaine, and lacosamide. Lacosamide, a voltage-gated sodium channel modulator with a slow inactivation mechanism, has demonstrated efficacy in neuropathic pain and retrospective analyses of TN cases. However, no prospective studies have systematically evaluated its impact in the acute setting.

Data collection will include demographic and clinical variables, TN characteristics, prior treatments, lacosamide infusion parameters, and concurrent medication use. Pain response will be assessed using an 11-point Numerical Pain Rating Scale (NPRS) at baseline, 2 hours post-infusion, at ED discharge, and at 24 hours and 7 days. Additional outcomes include changes in attack frequency, interference with daily activities (Brief Pain Inventory-Facial), patient satisfaction (PGIC), duration of pain relief, and adverse events at multiple time points.

Lacosamide will be administered intravenously per standard clinical practice, with continuous hemodynamic monitoring during and after infusion. Patients will be followed in the ED for at least 2 hours, with structured telephone follow-ups at 24 hours and 7 days post-infusion.

This study aims to generate real-world data on the effectiveness of intravenous lacosamide in acute TN exacerbations. Given the lack of high-quality evidence for emergency pain management in TN, findings may inform future controlled trials and refine clinical recommendations.

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Status Verified: 2025-04
• Study Start: 2025-04-21
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-12
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of classical or idiopathic trigeminal neuralgia according to the criteria of the International Classification of Headache Disorders (ICHD-3).
• Age over 18 years.
• Signed informed consent.

Exclusion Criteria

• Contraindication for treatment with lacosamide (previous hypersensitivity reaction, known atrioventricular block).
• Mental or psychiatric illness that interferes with the ability to understand and sign the informed consent.
• Language barrier.
• Lack of cooperation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain relief	2 hours post-infusion	Measured by the Numerical Pain Rating Scale (NPRS), which ranges from 0 (no pain) to 10 (worst imaginable pain). A decrease of ≥50% from baseline indicates improvement in pain intensity.
Adverse effects	Through study completion, an average of 1 week	Incidence of adverse effects

Secondary Outcome Measures

Name	Time	Method
Sustained pain relief	Through study completion, an average of 1 week	≥30%, ≥50% and 75% changes in the numerical pain rating scale (NPRS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Reduction in the number of paroxysms.
Impact on daily activities	After 7 days	Assessed using the Brief Pain Inventory-Facial (BPI-Facial), a 14-question scale measuring pain interference with daily activities. Each question is rated on an 11-point scale from 0 (no interference) to 10 (complete interference), with higher scores indicating greater impairment.
Patient Global Impression of Change	Through study completion, an average of 1 week	Measured using the 7-point Patient Global Impression of Change (PGIC) scale, which ranges from 1 (very much better) to 7 (very much worse). Lower scores indicate greater perceived improvement.

Trial Locations

Locations (1)

Hospital de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain