EpilepsyNCT01532726
Eslicarbazepine Acetate as Add-On Treatment to One Baseline Antiepileptic Drug (ESLADOBA)
An observational study of Epilepsy, run by Bial - Portela C S.A. at 1 site in Portugal.
Trial summary
This is a multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- ESL
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 1 sitePortugal
- Study dates
- Mar 2012to Sep 2014
- 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: Adults with Partial-Onset Seizures With or Without Secondary Generalization
Who may be able to join
- Male or female outpatient, 18 years or older;
- The patient has an established diagnosis of epilepsy and has experienced at least one partial-onset seizure, with or without secondary generalization, within four weeks prior to initiation of adjunctive ESL;
- The patient is not sufficiently controlled on a current antiepileptic monotherapy and, in the neurologist clinical judgment, it is in the patient's best interest to be prescribed with adjunctive ESL;
- The neurologist's decision to prescribe ESL has been made before and independently of his/her decision to include the patient in this study;
- The patient's treatment is in accordance with the SPC of ESL;
- Written informed consent from the patient (or legally acceptable representative, if the subject is unable to provide informed consent).
Who cannot join
- Known hypersensitivity to the active substance, carboxamide derivatives (e.g. oxcarbazepine or carbamazepine) or to any of its excipients;
- Patient with 2nd or 3rd degree atrioventricular block;
- Patient treated with an experimental drug within four weeks prior to the introduction of ESL;
- Female patient who is pregnant, lactating, or who is planning to become pregnant during the study period;
- Patient starting ESL outside the approved SPC at enrolment.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Hospital Fernando da Fonseca
Lisbon, Lisbon District, 2720-276
About this study
Official title: A Non-Interventional, Prospective Study to Assess Seizure Control and Tolerability of Eslicarbazepine Acetate as Adjunctive Therapy to One Baseline Antiepileptic Drug, in Adults With Partial-Onset Seizures With or Without Secondary Generalization
This is a multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of follow-up even if the final assessment is not performed.
Read the detailed description
To ensure non-interventional status, the neurologist's decision that it is in the patient's best interest to be prescribed with adjunctive ESL has to be made before and independently of his/her decision to include the patient in the study. At all circumstances during the study the patients will be treated and followed according to routine clinical practice. ESL and concomitant medication should be managed by the neurologist according to the respective Summary of Product Characteristics (SPC).In order to reflect real-life practice and to ensure the observational nature of this study, no fixed time-points for study assessment were defined. Intermediate follow-up data will be collected whenever a patient attends to the study's neurologist consultation.
- Conditions
- Epilepsy
- Being tested
- ESL
- Keywords
- Partial-Onset Seizures, Eslicarbazepine Acetate, ESL, BIA 2-093, BIAL
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESLDrug
Also called Zebinix
ESL 400/800/1200 mg tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| Eslicarbazepine Acetate (ESL) | ESL and concomitant medication should be managed by the neurologist according to the respective SPC.Summary of Product Characteristics Receives: Drug: ESL |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESL retention rate
Proportion of patients on ESL treatment at the final assessment
Measured: 9 months
Secondary outcomes (11)
CGI-C score at the final assessment.
Assessment of effectivenes
Measured: 9 monthss
Changes in CGI-S score from baseline to final assessment
Assessment of effectivenes
Measured: 9 months
CGI-Efficacy Index scores at the final assessment
Assessment of effectivenes
Measured: 9 months
Proportion of patients who are responders to ESL (at least 50% reduction in seizure frequency) at the final assessment
Assessment of effectivenes
Measured: 9 months
Proportion of seizure-free patients within the 12 weeks prior to final assessment
Assessment of effectivenes
Measured: 9 months
Proportion of seizure-free patients within the 4 weeks prior to final assessment
Assessment of effectivenes
Measured: 9 months
Changes in seizure frequency for partial seizures with or without secondary generalization, from baseline to final assessment
Assessment of effectivenes
Measured: 9 months
Changes in seizure frequency for partial seizures without secondary generalization, from baseline to final assessment
Assessment of effectivenes
Measured: 9 months
Changes in seizure frequency for partial seizures with secondary generalization, from baseline to final assessment
Assessment of effectivenes
Measured: 9 months
Changes in QOLIE-10-P scores from baseline to final assessment
assessment of Quality of life
Measured: 9 months
Occurrence of AEs during the study (overall and treatment-related)
assessment of Adverse Events
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- João Chaves, MD, Principal investigator, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532726
- Sponsor's protocol ID
- BIA-2093-403
- Status last verified
- Jan 2017
- First submitted
- 10 Feb 2012
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional, Prospective Study to Assess Seizure Control and Tolerability of Eslicarbazepine Acetate as Adjunctive Therapy to One Baseline Antiepileptic Drug, in Adults With Partial-Onset Seizures With or Without Secondary Generalization
- ClinicalTrials.gov ID
- NCT01532726
- Acronym / sponsor ID
- BIA-2093-403
- Conditions
- Epilepsy
- Keywords
- Partial-Onset Seizures, Eslicarbazepine Acetate, ESL, BIA 2-093, BIAL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Feb 2012 (estimated)
- 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 multicenter, non-interventional, prospective study. The observation period comprises at least 6 months, from the initiation of ESL add-on therapy in adult patients with partial-onset epilepsy not sufficiently controlled with one AED, until the first visit that occurs between 6 and 9 months of follow-up. The observation period will end after 9 months of follow-up even if the final assessment is not performed.
Detailed description
To ensure non-interventional status, the neurologist's decision that it is in the patient's best interest to be prescribed with adjunctive ESL has to be made before and independently of his/her decision to include the patient in the study. At all circumstances during the study the patients will be treated and followed according to routine clinical practice. ESL and concomitant medication should be managed by the neurologist according to the respective Summary of Product Characteristics (SPC).In order to reflect real-life practice and to ensure the observational nature of this study, no fixed time-points for study assessment were defined. Intermediate follow-up data will be collected whenever a patient attends to the study's neurologist consultation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eslicarbazepine Acetate (ESL) | – | Drug: ESLESL and concomitant medication should be managed by the neurologist according to the respective SPC.Summary of Product Characteristics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Partial-Onset Seizures With or Without Secondary Generalization
Key inclusion criteria (6 listed)
- Male or female outpatient, 18 years or older;
- The patient has an established diagnosis of epilepsy and has experienced at least one partial-onset seizure, with or without secondary generalization, within four weeks prior to initiation of adjunctive ESL;
- The patient is not sufficiently controlled on a current antiepileptic monotherapy and, in the neurologist clinical judgment, it is in the patient's best interest to be prescribed with adjunctive ESL;
- The neurologist's decision to prescribe ESL has been made before and independently of his/her decision to include the patient in this study;
- The patient's treatment is in accordance with the SPC of ESL;
Key exclusion criteria (5 listed)
- Known hypersensitivity to the active substance, carboxamide derivatives (e.g. oxcarbazepine or carbamazepine) or to any of its excipients;
- Patient with 2nd or 3rd degree atrioventricular block;
- Patient treated with an experimental drug within four weeks prior to the introduction of ESL;
- Female patient who is pregnant, lactating, or who is planning to become pregnant during the study period;
- Patient starting ESL outside the approved SPC at enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESLAlso: ZebinixESL 400/800/1200 mg tablets once daily | Drug | Eslicarbazepine Acetate (ESL) |
Primary outcome
ESL retention rate
Time frame: 9 months
Proportion of patients on ESL treatment at the final assessment
11 secondary outcomes
CGI-C score at the final assessment.
Time frame: 9 monthss
Changes in CGI-S score from baseline to final assessment
Time frame: 9 months
CGI-Efficacy Index scores at the final assessment
Time frame: 9 months
Proportion of patients who are responders to ESL (at least 50% reduction in seizure frequency) at the final assessment
Time frame: 9 months
Proportion of seizure-free patients within the 12 weeks prior to final assessment
Time frame: 9 months
Proportion of seizure-free patients within the 4 weeks prior to final assessment
Time frame: 9 months
Changes in seizure frequency for partial seizures with or without secondary generalization, from baseline to final assessment
Time frame: 9 months
Changes in seizure frequency for partial seizures without secondary generalization, from baseline to final assessment
Time frame: 9 months
Changes in seizure frequency for partial seizures with secondary generalization, from baseline to final assessment
Time frame: 9 months
Changes in QOLIE-10-P scores from baseline to final assessment
Time frame: 9 months
Occurrence of AEs during the study (overall and treatment-related)
Time frame: 9 months
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 6 Jan 2017.
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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.
João Chaves, MD principal investigator
Centro Hospitalar do Porto
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 Epilepsy, run by Bial - Portela C S.A. at 1 site in Portugal.
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 6 inclusion and 5 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 6 Jan 2017. 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 Portugal. 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?
ESL retention rate (time frame: 9 months). 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 6 Jan 2017.