Health TrialsbyHealthPanel

Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia

ConditionTrigeminal Neuralgia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult patients diagnosed with primary trigeminal neuralgia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lacosamide

    Drug

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
2 hours post-infusion
2

Adverse effects

Incidence of adverse effects

Time frame
Through study completion, an average of 1 week

Secondary outcomes

1

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.

Time frame
Through study completion, an average of 1 week
2

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.

Time frame
After 7 days
3

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.

Time frame
Through study completion, an average of 1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitari de Bellvitge

Lead sponsor

Source ClinicalTrials.gov
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