Prospective Study of Eslicarbazepine in Adults With Focal-Onset Seizures
ConditionFocal-Onset Seizures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKing Edward Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Eslicarbazepine acetate
DrugEslicarbazepine 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.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: Newly Diagnosed / Treatment-Naïve1 intervention
Group B: Previously Treated With Carbamazepine/Oxcarbazepine1 intervention
Trial outcomes
Primary outcomes
1
Change in Seizure Frequency
Time frame
From Baseline to Month 32
Seizure Response Rate
Time frame
From Baseline to Month 3Secondary outcomes
1
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 32
Adverse Events and Serious Adverse Events
Time frame
From Baseline through Month 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov