Focal Epilepsy
Conditions
Keywords
partial onset seizures with or without secondary generalization
Brief summary
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).
Interventions
None listed
Sponsors
Eisai GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Partial onset seizures with or without secondary generalisation in conjunction with a diagnosed epilepsy of symptomatic or unknown course. 2. The decision to prescribe Eslicarbazepine acetate (ESL) was taken independent of and prior to enrollment into this study. 3. Treatment with ESL is in agreement with the valid summary of product characteristics (SmPC) version, particularly with the licensed indication. 4. Age 18 years and older. 5. Participant's written consent.
Exclusion criteria
1. Known psychogenic non-epileptic attacks. 2. Participation in an interventional study. 3. Previous enrollment in the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL) | At follow-up visit (occurring after approximately 6 months of treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 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) |
| 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 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 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) | — |
| Change from baseline in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) | 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) | Only in centers where this questionnaire is part of the clinical routine. |
Countries
Germany
Outcome results
None listed