A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)

Study Overview
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Brief Summary
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This was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients enrolled into the study were not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients were seen at baseline and then during normal clinical visits at intervals. Patients in this study were assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.

Official Title
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An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Prospective Study Evaluating Retention Rate, Seizure Control and Tolerability of Eslicarbazepine Acetate (ESL) as Adjunctive Treatment to One Baseline Antiepileptic Drug in Adult Patients With Partial-Onset Seizures With or Without Secondary Generalisation

Conditions
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Partial Onset Seizures

Intervention / Treatment
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* Drug: Eslicarbazepine Acetate tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The decision to prescribe ESL was made by the physician before and independently of his/her decision to include the patient in the study Patients treated with one drug licensed for monotherapy in partial onset seizures Based on the physician's clinical judgment, the patient seizure activity was not controlled sufficiently with a current monotherapy and it was in the patient's best interest to be prescribed adjunctive ESL Patient was prescribed ESL no longer than 2 weeks before the baseline Treatment with ESL was to be commenced in line with the drug's license and Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC) Aged 18 years or older Signed written informed consent Exclusion Criteria: Patients that had started ESL outside the approved SPC at enrolment Simultaneous participation in an interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eslicarbazepine Acetate tablets<br> | Drug: Eslicarbazepine Acetate tablets<br>* The Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC) recommended a starting dose of 400 mg once-daily (QD) which was increased to 800 mg QD after one or two weeks. Based on individual response, the dose was increased to 1200 mg QD. Treatment decisions were made by clinicians in agreement with the participant, and were independent of participation in the study.<br>* Other names: ESL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Seizure Frequency after 3 and 6 months from Baseline | Change in overall seizure frequency calculated as absolute and percent changes after 3 and 6 months from baseline compared to the seizure frequency 3 months before introduction of ESL. | Baseline, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESL, Partial onset seizures, Retention Rate, Seizure Control, Antiepileptic, Secondary Generalisation