Focal EpilepsyNCT03082222
ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions
An observational study of Focal Epilepsy, run by Eisai GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy
- How many people
- 246 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to 29 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants appearing to their treating physician or clinic for routine visits will be invited to participate in the study
Who may be able to join
- Partial onset seizures with or without secondary generalisation in conjunction with a diagnosed epilepsy of symptomatic or unknown course.
- The decision to prescribe Eslicarbazepine acetate (ESL) was taken independent of and prior to enrollment into this study.
- Treatment with ESL is in agreement with the valid summary of product characteristics (SmPC) version, particularly with the licensed indication.
- Age 18 years and older.
- Participant's written consent.
Who cannot join
- Known psychogenic non-epileptic attacks.
- Participation in an interventional study.
- Previous enrollment in the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Focal Epilepsy
- Keywords
- partial onset seizures with or without secondary generalization
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)
Measured: At follow-up visit (occurring after approximately 6 months of treatment)
Secondary outcomes (7)
Change from baseline in total seizure frequency
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: From signing of informed consent up to the follow-up visit (occurring after approximately 6 months of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study startJul 2015
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082222
- Sponsor's protocol ID
- E2093-M044-405
- Status last verified
- Aug 2019
- First submitted
- 21 Feb 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03082222
- Acronym / sponsor ID
- E2093-M044-405
- Conditions
- Focal Epilepsy
- Keywords
- partial onset seizures with or without secondary generalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Eisai GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants appearing to their treating physician or clinic for routine visits will be invited to participate in the study
Key inclusion criteria (5 listed)
- Partial onset seizures with or without secondary generalisation in conjunction with a diagnosed epilepsy of symptomatic or unknown course.
- The decision to prescribe Eslicarbazepine acetate (ESL) was taken independent of and prior to enrollment into this study.
- Treatment with ESL is in agreement with the valid summary of product characteristics (SmPC) version, particularly with the licensed indication.
- Age 18 years and older.
- Participant's written consent.
Key exclusion criteria (3 listed)
- Known psychogenic non-epileptic attacks.
- Participation in an interventional study.
- Previous enrollment in the current study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL)
Time frame: At follow-up visit (occurring after approximately 6 months of treatment)
7 secondary outcomes
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)
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)
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 seizure free state
Time frame: 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Epilepsy, run by Eisai GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants continuing treatment with Eslicarbazepine Acetate (ESL) (time frame: At follow-up visit (occurring after approximately 6 months of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.