ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

An Open, Multicentric, Non-Interventional Observational Study Investigating Retention, Seizure Control and Tolerability in Epilepsy Patients With Partial Onset Seizures Receiving Eslicarbazepine Acetate (ESL) in Different Therapy Situations

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).

Study Overview

• Status: Completed
• Conditions: Focal Epilepsy

• Study Type: Observational
• Enrollment (Actual): 246

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants appearing to their treating physician or clinic for routine visits will be invited to participate in the study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 1; Participants with epilepsy, partial onset seizures with or without secondary generalization with one concomitant antiepileptic drug (AED) at baseline
Group 2; Participants with epilepsy, partial onset seizures with or without secondary generalization with two or more concomitant AEDs at baseline
Group 3; Participants with epilepsy, partial onset seizures with or without secondary generalization with eslicarbazepine acetate (ESL) as anticonvulsant monotherapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Responder Rate	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)	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)	Only in centers where this questionnaire is part of the clinical routine.	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)

Collaborators and Investigators

• Sponsor: Eisai GmbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): October 29, 2018
• Study Completion (ACTUAL): October 29, 2018

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (ACTUAL): March 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: partial onset seizures with or without secondary generalization
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: E2093-M044-405