Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia

NCT06851910 | Recruiting

• 1 other identifier: EOM043/24
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Trigeminal Neuralgia

Keywords

trigeminal neuralgia; lacosamide; acute treatment; rescue treatment

Outcome Measures

Primary Outcomes (2)

• 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

• Adverse effects

  Incidence of adverse effects

  Through study completion, an average of 1 week

Secondary Outcomes (3)

• Sustained pain relief

  Through study completion, an average of 1 week

• Impact on daily activities

  After 7 days

• Patient Global Impression of Change

  Through study completion, an average of 1 week

Interventions

Lacosamide DRUG

Patients will be included if they are prescribed intravenous lacosamide for their trigeminal neuralgia exacerbation

Also known as: Vimpat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with primary trigeminal neuralgia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Albert Muñoz Vendrell, PhD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

ES (1)