Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia

Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia: A Prospective Observational Study

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

Study Overview

• Status: Recruiting
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Drug: Lacosamide

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital De Bellvitge
      • Contact: Albert Muñoz Vendrell, PhD; Phone Number: +34932607412; Email: unitatcefalea@bellvitgehospital.cat
      • Principal Investigator: Albert Muñoz Vendrell, PhD
      • Sub-Investigator: Mariano Huerta Villanueva, PhD
      • Sub-Investigator: Sergio Campoy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with primary trigeminal neuralgia

Description

All patients diagnosed with trigeminal neuralgia who present to the emergency department of Hospital de Bellvitge for an acute pain exacerbation and are prescribed intravenous lacosamide as symptomatic pain treatment, according to the treating physician's discretion, will be considered for inclusion.

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Incidence of adverse effects	Through study completion, an average of 1 week
Pain relief	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.	2 hours post-infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained pain relief	≥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.	Through study completion, an average of 1 week
Impact on daily activities	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.	After 7 days
Patient Global Impression of Change	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.	Through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Albert Muñoz Vendrell, PhD, Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: lacosamide; trigeminal neuralgia; rescue treatment; acute treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Acute Pain; Neuralgia; Trigeminal Neuralgia; Molecular Mechanisms of Pharmacological Action; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Anticonvulsants; Lacosamide
• Other Study ID Numbers: EOM043/24

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No