Prospective Study of Eslicarbazepine in Adults With Focal-Onset Seizures

Overview

This prospective multicenter observational study will evaluate the effectiveness, safety, tolerability, and impact on quality of life of eslicarbazepine in adults with focal-onset seizures in routine clinical practice. Participants will include newly diagnosed patients and patients previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects. Treatment with eslicarbazepine will be initiated or changed at the discretion of the treating physician in accordance with routine clinical practice. Participants will be followed for 3 months.

This prospective, multicenter observational study will assess the effectiveness, safety, and tolerability of eslicarbazepine in adults with focal-onset epilepsy, including newly diagnosed patients and patients previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects. Treatment decisions, including the decision to initiate eslicarbazepine or switch from another antiseizure medication, will be made by the treating physician according to routine clinical practice and the approved product information. The study will therefore observe outcomes associated with eslicarbazepine use without assigning participants to treatment. Eslicarbazepine will be administered orally once daily. Newly diagnosed patients will typically start at 400 mg/day and increase to 800 mg/day after one week. Patients switching from carbamazepine or oxcarbazepine may start at 400-600 mg/day according to clinical judgment and may undergo an overnight switch or cross-titration. If clinically indicated and tolerated, the dose may be increased to a maximum of 1600 mg/day. Dose adjustments will be guided by tolerability, seizure control, and adverse-event monitoring. Participants will be assessed at baseline, Day 7, and Month 3. Data collected will include demographic and clinical information, concomitant medications, seizure occurrence and frequency, quality of life using the Patient Quality of Life in Epilepsy (QOLIE-10-P) questionnaire, treatment compliance, and adverse events and serious adverse events. The study will include approximately 1500 participants from multiple institutes/hospitals across Pakistan.