ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

Study Overview
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Brief Summary
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This is a non interventional prospective study. Centers will enroll adult participants with partial onset seizures with or without secondary generalisation for whom the clinician has decided to initiate eslicarbazepine acetate (ESL) as an adjunctive therapy or monotherapy prior to the decision to take part in this study. Participants to be enrolled into the study will receive ESL either as an adjunctive therapy to one baseline antiepileptic drug (AED) or to at least two baseline AEDs or as monotherapy. Participants will be seen at baseline and at a follow-up visit after approximately 6 months to assess retention, efficacy, tolerability, quality of life (optional), and cognitive performances (optional).

Official Title
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An Open, Multicentric, Non-Interventional Observational Study Investigating Retention, Seizure Control and Tolerability in Epilepsy Patients With Partial Onset Seizures Receiving Eslicarbazepine Acetate (ESL) in Different Therapy Situations

Conditions
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Focal Epilepsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Partial onset seizures with or without secondary generalisation in conjunction with a diagnosed epilepsy of symptomatic or unknown course. The decision to prescribe Eslicarbazepine acetate (ESL) was taken independent of and prior to enrollment into this study. Treatment with ESL is in agreement with the valid summary of product characteristics (SmPC) version, particularly with the licensed indication. Age 18 years and older. Participant's written consent. Exclusion Criteria: Known psychogenic non-epileptic attacks. Participation in an interventional study. Previous enrollment in the current study.

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 |
| --- | --- |
| Group 1<br>Participants with epilepsy, partial onset seizures with or without secondary generalization with one concomitant antiepileptic drug (AED) at baseline | |
| Group 2<br>Participants with epilepsy, partial onset seizures with or without secondary generalization with two or more concomitant AEDs at baseline | |
| Group 3<br>Participants with epilepsy, partial onset seizures with or without secondary generalization with eslicarbazepine acetate (ESL) as anticonvulsant monotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL) |  | At follow-up visit (occurring after approximately 6 months of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total seizure frequency |  | Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment) | 
| Change from baseline in seizure frequency by seizure type |  | Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment) | 
| Responder Rate | Percentage of participants achieving a reduction in total seizure frequency by at least 50% within the 3-month period prior to Follow-Up in comparison with Baseline (the 3-month period prior to initiation of treatment with ESL) | Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment) | 
| Percentage of participants achieving seizure free state |  | 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment) | 
| Change from baseline in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) | Only in centers where this questionnaire is part of the clinical routine. | Baseline (the 3 months period prior to initiation of treatment with ESL) and 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment) | 
| Change from baseline in NeuroCog FX subset scores |  | Baseline (the 3 months period prior to initiation of treatment with ESL) and at follow-up visit (occurring after approximately 6 months of treatment) | 
| Percentage of participants with Adverse Events (AEs) |  | From signing of informed consent up to the follow-up visit (occurring after approximately 6 months of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial onset seizures with or without secondary generalization