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This is a multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of follow-up even if the final assessment is not performed.
To ensure non-interventional status, the neurologist's decision that it is in the patient's best interest to be prescribed with adjunctive ESL has to be made before and independently of his/her decision to include the patient in the study. At all circumstances during the study the patients will be treated and followed according to routine clinical practice. ESL and concomitant medication should be managed by the neurologist according to the respective Summary of Product Characteristics (SPC).In order to reflect real-life practice and to ensure the observational nature of this study, no fixed time-points for study assessment were defined. Intermediate follow-up data will be collected whenever a patient attends to the study's neurologist consultation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eslicarbazepine Acetate (ESL) | ESL and concomitant medication should be managed by the neurologist according to the respective SPC.Summary of Product Characteristics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESL | Drug | ESL 400/800/1200 mg tablets once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| ESL retention rate | Proportion of patients on ESL treatment at the final assessment | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| CGI-C score at the final assessment. | Assessment of effectivenes | 9 monthss |
| Changes in CGI-S score from baseline to final assessment | Assessment of effectivenes |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with Partial-Onset Seizures With or Without Secondary Generalization
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| Name | Affiliation | Role |
|---|---|---|
| João Chaves, MD | Centro Hospitalar do Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Fernando da Fonseca | Lisbon | Lisbon District | 2720-276 | Portugal |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C416835 | eslicarbazepine acetate |
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| 9 months |
| CGI-Efficacy Index scores at the final assessment | Assessment of effectivenes | 9 months |
| Proportion of patients who are responders to ESL (at least 50% reduction in seizure frequency) at the final assessment | Assessment of effectivenes | 9 months |
| Proportion of seizure-free patients within the 12 weeks prior to final assessment | Assessment of effectivenes | 9 months |
| Proportion of seizure-free patients within the 4 weeks prior to final assessment | Assessment of effectivenes | 9 months |
| Changes in seizure frequency for partial seizures with or without secondary generalization, from baseline to final assessment | Assessment of effectivenes | 9 months |
| Changes in seizure frequency for partial seizures without secondary generalization, from baseline to final assessment | Assessment of effectivenes | 9 months |
| Changes in seizure frequency for partial seizures with secondary generalization, from baseline to final assessment | Assessment of effectivenes | 9 months |
| Changes in QOLIE-10-P scores from baseline to final assessment | assessment of Quality of life | 9 months |
| Occurrence of AEs during the study (overall and treatment-related) | assessment of Adverse Events | 9 months |