ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-10-29

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).

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Detailed Description

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Conditions

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Focal Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

No interventions assigned to this group

Group 2

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

No interventions assigned to this group

Group 3

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

No interventions assigned to this group

Eligibility Criteria

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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.