Focal-Onset Seizures
Conditions
Keywords
Eslicarbazepine, Eslicarbazepine acetate, APTIOM, Focal-onset seizures, Partial-onset seizures, Focal epilepsy, Carbamazepine, Oxcarbazepine, Seizure control, Quality of life, QOLIE-10-P, Real-world evidence
Brief summary
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.
Detailed description
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.
Interventions
Eslicarbazepine acetate administered orally once daily as prescribed by the treating physician in routine clinical practice. Newly diagnosed patients will typically initiate treatment at 400 mg/day and increase to 800 mg/day after one week. Patients switching from carbamazepine or oxcarbazepine may initiate treatment at 400-600 mg/day according to clinical judgment. Dose adjustments, including increases up to 1600 mg/day when clinically indicated and tolerated, will be determined by the treating physician.
Sponsors
King Edward Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (aged at least 18 years) with diagnosed partial-onset seizures. * Newly diagnosed (treatment-naïve) or previously treated with Carbamazepine or Oxcarbazepine and inadequately controlled or intolerant. * Patient or Legal Representative is willing and able to provide informed consent, or, in the absence of a legal representative, an Independent Healthcare Professional provides authorization for patient enrolment.
Exclusion criteria
* Any hypersensitivity to Eslicarbazepine. * Female patients who are pregnant or lactating. * Patients who have a contraindication to the medicine or any component of prescribed therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Seizure Frequency | From Baseline to Month 3 |
| Seizure Response Rate | From Baseline to Month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QOLIE-10-P Score | From Baseline to Month 3 | Patient Quality of Life in Epilepsy Score has 10 questions being scored 1 to 5 each with lower score indicating poorer quality of life and higher score indicating better quality of life with total score ranging from 10 to 50. An increase in score indicates improvement in quality of life. |
| Adverse Events and Serious Adverse Events | From Baseline through Month 3 | — |
Countries
Pakistan
Contacts
CONTACTSafia Assistant Professor Neurology, FCPS Neurology, PhD Scholar
Outcome results
None listed