An observational study in Focal-Onset Seizures, sponsored by King Edward Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by King Edward Medical University · Observational
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.
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 140 across 216 observational studies indexed under Seizures.
Browse Seizures studies →King Edward Medical University is the lead sponsor of 82 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of approximately 1,500 adult male and female patients with diagnosed focal-onset (partial-onset) seizures across multiple institutes/hospitals in Pakistan. Participants will include newly diagnosed, treatment-naïve patients and patients previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects. Eslicarbazepine treatment will be initiated or switched at the discretion of the treating physician in accordance with routine clinical practice and applicable prescribing information.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with diagnosed focal-onset seizures who are newly diagnosed/treatment-naïve and receive eslicarbazepine as part of routine clinical care.
Drug: Eslicarbazepine acetate
Adults with focal-onset seizures previously treated with carbamazepine or oxcarbazepine who have inadequate seizure control or intolerable adverse effects and receive eslicarbazepine as part of routine clinical care.
Drug: Eslicarbazepine acetate
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.
Change in Seizure Frequency
Time frame: From Baseline to Month 3
Seizure Response Rate
Time frame: From Baseline to Month 3
Change in QOLIE-10-P Score
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.
Time frame: From Baseline to Month 3
Adverse Events and Serious Adverse Events
Time frame: From Baseline through Month 3
Plan to share: No
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
Of 53 non-industry observational studies under Seizures, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 18. This study's planned 12 months is below that.
Counting every sponsor, half of 80 studies reached it within 38 months; a quarter within 18 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
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King Edward Medical University