ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

Completed

• Conditions: Focal Epilepsy

• Registration Number: NCT03082222
• Lead Sponsor: Eisai GmbH

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-17
• Primary Completion: 2018-10-29
• Study Completion: 2018-10-29
• Status Verified: 2019-08
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)	At follow-up visit (occurring after approximately 6 months of treatment)

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)	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.
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)