Acute exacerbations of trigeminal neuralgia Nervous System Diseases
Conditions
Interventions
Participants were randomized in a 1:1 ratio to receive a single intravenous dose of lacosamide or phenytoin. The allocation sequence was implemented using sequentially numbered, sealed envelopes prepa
Sponsors
Instituto Nacional de Neurología y Neurocirugía
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. Diagnosis of classical, secondary, or idiopathic trigeminal neuralgia according to the International Classification of Headache Disorders, third edition (ICHD-3) 3. Acute exacerbation, defined as a sudden increase in pain frequency or intensity that is not controlled with the participant’s usual oral treatment 4. Requirement for intravenous treatment in a hospital or emergency department setting 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to lacosamide or phenytoin 2. Use of lacosamide during the previous two weeks 3. Clinically relevant cardiac arrhythmia, particularly uncontrolled second- or third-degree atrioventricular block 4. Severe hepatic impairment 5. Severe renal impairment 6. Pregnancy or breastfeeding 7. Active epileptic seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant pain reduction, defined as the proportion of participants achieving at least a 50% reduction in pain intensity from baseline, measured using a 0–10 numerical rating scale, at 2 hours after completion of the assigned intravenous infusion | — |
Countries
Mexico
Contacts
Public ContactJavier Andres Galnares-Olalde
Outcome results
None listed