ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

September 11, 2019 updated by: Eisai GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Multiple Locations, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)
Time Frame: At follow-up visit (occurring after approximately 6 months of treatment)
At follow-up visit (occurring after approximately 6 months of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in total seizure frequency
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 3 months period prior to follow-up visit (occurring after approximately 6 months of treatment)
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)
Time Frame: 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.
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
Time Frame: Baseline (the 3 months period prior to initiation of treatment with ESL) and at follow-up visit (occurring after approximately 6 months of treatment)
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)
Time Frame: From signing of informed consent up to the follow-up visit (occurring after approximately 6 months of treatment)
From signing of informed consent up to the follow-up visit (occurring after approximately 6 months of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2093-M044-405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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