Actively Recruiting
Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia: A Prospective Observational Study
Led by Hospital Universitari de Bellvitge · Updated on 2025-04-29
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intravenous lacosamide as a rescue treatment for sudden worsening of pain in patients with trigeminal neuralgia, a condition marked by severe facial pain that can be difficult to manage with standard treatments. This prospective observational study aims to assess the effectiveness and safety of lacosamide when given in an emergency department setting. The trial is sponsored by Hospital Universitari de Bellvitge and involves about 20 patients over two years. During the study, patients presenting with acute trigeminal neuralgia pain will receive intravenous lacosamide based on their doctor's decision. The medication will be given following standard clinical practice, with continuous monitoring of heart function during and after the infusion. Patients will stay in the emergency department for at least two hours after treatment, with follow-up calls scheduled at 24 hours and seven days to check on their condition. Participants will be assessed using several measures including an 11-point pain rating scale at different times after treatment, changes in attack frequency, impact on daily activities, patient satisfaction, duration of pain relief, and any side effects. Data collection will include patient demographics, pain characteristics, prior treatments, and medication details. The study will provide real-world information on lacosamide's role in managing acute pain episodes in trigeminal neuralgia and may help guide future research and treatment recommendations.
CONDITIONS
Brief Title
Intravenous Lacosamide for the Treatment of Acute Pain in Trigeminal Neuralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of classical or idiopathic trigeminal neuralgia according to International Classification of Headache Disorders (ICHD-3) criteria
- Age over 18 years
- Signed informed consent
You will not qualify if you...
- Contraindication to lacosamide (previous hypersensitivity reaction or known atrioventricular block)
- Mental or psychiatric illness that interferes with understanding or signing informed consent
- Language barrier
- Lack of cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single acute treatment event
Participants receive intravenous lacosamide as a rescue treatment for acute trigeminal neuralgia pain exacerbations during their emergency department visit with continuous monitoring.
1 visit (in-person) including 2 hours of monitoring in the emergency department
Duration - 7 days
Participants are followed up after treatment to assess pain relief, impact on daily activities, patient satisfaction, and any adverse events.
Telephone follow-ups at 24 hours and 7 days post-infusion
Trial Site Locations
Total: 1 location
1
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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