ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

Eisai

Status: Completed

Conditions: Focal Epilepsy

Study type: Observational

Funder types: Industry

Identifiers

NCT03082222

E2093-M044-405

Details and patient eligibility

About

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).

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

246 participants in 3 patient groups

Group 1

Description:

Participants with epilepsy, partial onset seizures with or without secondary generalization with one concomitant antiepileptic drug (AED) at baseline

Group 2

Description:

Participants with epilepsy, partial onset seizures with or without secondary generalization with two or more concomitant AEDs at baseline

Group 3

Description:

Participants with epilepsy, partial onset seizures with or without secondary generalization with eslicarbazepine acetate (ESL) as anticonvulsant monotherapy