EpilepsyPhase 3NCT02484001
Eslicarbazepine Acetate (BIA 2-093) as Monotherapy in Patients With Newly Diagnosed Partial-onset Seizures
A Phase 3 study testing ESL 800 mg, ESL 1200 mg and ESL 1600 mg in people with Epilepsy, run by Bial - Portela C S.A..
Trial summary
This is a Phase III, multinational, open-label, non-controlled study with subjects under treatment in the double-blind BIA-2093-311 study (NCT01162460). Subjects will enter the open-label extension study after the preceding double-blind study was unblinded and they are attending their last Extension Phase Visit (EPV)… 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 800 mg, ESL 1200 mg and ESL 1600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 11 Sep 2018
- Phase
- Phase 3
- 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
Who may be able to join
- For inclusion in the extension study, subjects must fulfill all of the following at Visit 1 (Day 1, start of the open-label extension study):
- Participated in the preceding double-blind study and were still ongoing at the time of unblinding.
- Have signed informed consent before undergoing any activities related to the open-label extension study.
- Demonstrated cooperation and willingness to complete all aspects of the study.
- Female subjects without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative serum ß-human chorionic gonadotropin (hCG) test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the Post-study Visit (PSV).
Who cannot join
- Subjects having any of the following at Visit 1 are to be excluded from the study:
- Excluded from the double-blind study due to seizure in the Maintenance or Extension Phase, or at dose level C (either CBZ-CR or ESL), or discontinued prematurely due to any other reason in the double-blind study.
- Presence of any major protocol violation during the double-blind study which may have an impact on the compliance during this extension study.
- Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide-Severity Rating Scale (C-SSRS).
- Occurrence of an adverse event (AE) indicating a suspected presence of atrioventricular block (2nd degree and above) or of any other AEs during the double-blind study which are judged by the investigator as contraindicative to further participation in the open-label extension study.
- Events of alcohol, drug, or medication abuse during the preceding double-blind study.
Show all 9Show fewer
- Relevant clinical laboratory abnormalities (e.g. sodium <125 mmol/L, alanine or aspartate transaminases >2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (as reported at Visit 1).
- Pregnancy or lactating.
- Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the extension-study protocol.
About this study
Official title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures: a Double-blind, Randomized, Active-controlled, Parallel-group, Multicenter Clinical Study - Open-label ESL Extension
This is a Phase III, multinational, open-label, non-controlled study with subjects under treatment in the double-blind BIA-2093-311 study (NCT01162460).
Subjects will enter the open-label extension study after the preceding double-blind study was unblinded and they are attending their last Extension Phase Visit (EPV) of the double-blind study.
Read more
For all subjects, the day of the last EPV of the double-blind study will also be the day of Visit 1 for the open-label extension study. All subjects will receive Eslicarbazepine acetate (ESL) under open-label conditions at Visit 1.
The complete study duration including treatment with ESL under open-label conditions and follow-up is expected to last approximately 2 years (105 weeks).
In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be discontinued prematurely within 42 days after achievement of MA.
Read the detailed description
For all subjects participating in this open-label extension study, the last Extension Phase Visit (EPV) of the double-blind study will also be the day of Visit 1 for this study. At this visit, the subjects will be asked if they are willing to continue in an open-label extension and to receive treatment with Eslicarbazepine acetate (ESL) for up to additional 2 years. In case marketing authorization (MA) of ESL as monotherapy will be achieved prior to the end of 2017, the study may be discontinued prematurely within 42 days after achievement of MA.
For subjects not willing to enter the extension study, IMP from the double-blind study (CBZ-CR or ESL) is to be discontinued according to the down-titration scheme in the clinical study protocol and commercially available antiepileptic drug (AED) is to be introduced according to investigator's discretion.
In case the subject is willing to enter the extension study, subjects already treated with ESL will continue with their last evaluated dose (ESL 800 mg, 1200 mg or 1600 mg QD).
Subjects previously treated with CBZ-CR will start with ESL 400 mg QD for one week followed by up-titration to the ESL target dose which is equivalent to the last evaluated CBZ-CR dose level (i.e. CBZ-CR 200 mg BID -> ESL 800 mg QD; CBZ-CR 400 mg BID -> ESL 1200 mg QD; CBZ-CR 600 mg BID -> ESL 1600 mg QD) in steps of 400 mg dose increase per week.
All subjects previously treated with CBZ-CR, regardless of their last evaluated dose level, will start CBZ-CR down-titration two weeks after first receipt of ESL treatment as part of the double-blind study and as outlined in the BIA-2093-311 study protocol.
In case of new seizures, the ESL dose can be increased to a maximum dose of ESL 1600 mg QD [dose level C], depending on the investigator's decision. Any up-titration should be performed in weekly steps of 400 mg.
If according to the investigator's opinion the subject may benefit from a combination treatment, an additional commercially available AED as add-on can be introduced at the investigator's discretion.
If deemed necessary by the investigator, e.g. due to occurrence of adverse events, the dose of ESL can be reduced according to investigator's discretion, as long as the dose remains in the range of 800 mg QD to 1600mg QD.
In case the subject started with the extension study but is not willing to continue at any time, the subject has to be switched to commercially available AEDs to receive the best standard of care according to the investigator's discretion. Down-titration of ESL as required should be performed in steps of 400 mg decrease per week
- Conditions
- Epilepsy
- Being tested
- ESL 800 mg, ESL 1200 mg, ESL 1600 mg, ESL 400 mg
- Keywords
- Eslicarbazepine acetate, BIA 2-093, Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESL 800 mgDrug
Also called BIA 2-093
one (1) tablet of 800 mg (QD).
ESL 1200 mgDrug
Also called BIA 2-093
one (1) and a half tablets of 800 mg (QD). ESL tablets are scored and can be divided in two equal halves (each one containing 400 mg ESL)
ESL 1600 mgDrug
Also called BIA 2-093
two (2) tablets of 800 mg (QD).
ESL 400 mgDrug
Also called BIA 2-093
half tablet of 800 mg (QD). ESL tablets are scored and can be divided in two equal halves (each one containing 400 mg ESL)
| Study group | Role | What they receive |
|---|---|---|
| ESL 800 mg | Experimental | ESL will be administered orally once daily (QD) Receives: Drug: ESL 800 mg |
| ESL 1200 mg | Experimental | ESL will be administered orally once daily (QD) Receives: Drug: ESL 1200 mg |
| ESL 1600 mg | Experimental | ESL will be administered orally once daily (QD) Receives: Drug: ESL 1600 mg |
| ESL 400 mg | Experimental | ESL will be administered orally once daily (QD) Receives: Drug: ESL 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure
Time to treatment failure, defined as time from start of open-label ESL treatment at Visit 1 until withdrawal due to AE or due to lack of efficacy (i.e. inadequate seizure control), is the primary endpoint of this study. Open-label ESL treatment will be provided for approximately 2 years. Regular Treatment Visits (TVs) will be performed every 3 months after start of treatment.
Measured: up to 2 years
Secondary outcomes (1)
Number of Adverse Events (AEs) reported by patient
The investigator will monitor AEs at each visit, from signing of informed consent throughout the study, including at Early Discontinuation Visit (EDV), End-of-study (EOS) Visit, and Post-study Visit (PSV), using an unstructured interview and by review of the subject diaries. The investigator will inquire generally about the subject's well-being since the last visit. Details of any reported AEs will be recorded at all scheduled and unscheduled visits as well as those reported during any telephone contact. In addition, comments in the subject diaries will be reviewed by the investigator and any events considered by the investigator to be an AE will be recorded as such.
Measured: participants will be followed for the duration of the clinical trial, an expected average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start1 Mar 2016
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484001
- Sponsor's protocol ID
- BIA-2093-311/EXT
- Status last verified
- Oct 2018
- First submitted
- 23 Jun 2015
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Trinka E, Rocamora R, Chaves J, Koepp MJ, Ruegg S, Holtkamp M, Moreira J, Fonseca MM, Castilla-Fernandez G, Ikedo F. Lipid profile with eslicarbazepine acetate and carbamazepine monotherapy in adult patients with newly diagnosed focal seizures: post hoc analysis of a phase III trial and open-label extension study. Ther Adv Neurol Disord. 2023 Sep 4;16:17562864231193530. doi: 10.1177/17562864231193530. eCollection 2023.
PubMed 37675038
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures: a Double-blind, Randomized, Active-controlled, Parallel-group, Multicenter Clinical Study - Open-label ESL Extension
- ClinicalTrials.gov ID
- NCT02484001
- Acronym / sponsor ID
- BIA-2093-311/EXT
- Conditions
- Epilepsy
- Keywords
- Eslicarbazepine acetate, BIA 2-093, Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 29 Jun 2015 (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 Phase III, multinational, open-label, non-controlled study with subjects under treatment in the double-blind BIA-2093-311 study (NCT01162460).
Subjects will enter the open-label extension study after the preceding double-blind study was unblinded and they are attending their last Extension Phase Visit (EPV) of the double-blind study.
For all subjects, the day of the last EPV of the double-blind study will also be the day of Visit 1 for the open-label extension study. All subjects will receive Eslicarbazepine acetate (ESL) under open-label conditions at Visit 1.
The complete study duration including treatment with ESL under open-label conditions and follow-up is expected to last approximately 2 years (105 weeks).
In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be discontinued prematurely within 42 days after achievement of MA.
Detailed description
For all subjects participating in this open-label extension study, the last Extension Phase Visit (EPV) of the double-blind study will also be the day of Visit 1 for this study. At this visit, the subjects will be asked if they are willing to continue in an open-label extension and to receive treatment with Eslicarbazepine acetate (ESL) for up to additional 2 years. In case marketing authorization (MA) of ESL as monotherapy will be achieved prior to the end of 2017, the study may be discontinued prematurely within 42 days after achievement of MA.
For subjects not willing to enter the extension study, IMP from the double-blind study (CBZ-CR or ESL) is to be discontinued according to the down-titration scheme in the clinical study protocol and commercially available antiepileptic drug (AED) is to be introduced according to investigator's discretion.
In case the subject is willing to enter the extension study, subjects already treated with ESL will continue with their last evaluated dose (ESL 800 mg, 1200 mg or 1600 mg QD).
Subjects previously treated with CBZ-CR will start with ESL 400 mg QD for one week followed by up-titration to the ESL target dose which is equivalent to the last evaluated CBZ-CR dose level (i.e. CBZ-CR 200 mg BID -> ESL 800 mg QD; CBZ-CR 400 mg BID -> ESL 1200 mg QD; CBZ-CR 600 mg BID -> ESL 1600 mg QD) in steps of 400 mg dose increase per week.
All subjects previously treated with CBZ-CR, regardless of their last evaluated dose level, will start CBZ-CR down-titration two weeks after first receipt of ESL treatment as part of the double-blind study and as outlined in the BIA-2093-311 study protocol.
In case of new seizures, the ESL dose can be increased to a maximum dose of ESL 1600 mg QD [dose level C], depending on the investigator's decision. Any up-titration should be performed in weekly steps of 400 mg.
If according to the investigator's opinion the subject may benefit from a combination treatment, an additional commercially available AED as add-on can be introduced at the investigator's discretion.
If deemed necessary by the investigator, e.g. due to occurrence of adverse events, the dose of ESL can be reduced according to investigator's discretion, as long as the dose remains in the range of 800 mg QD to 1600mg QD.
In case the subject started with the extension study but is not willing to continue at any time, the subject has to be switched to commercially available AEDs to receive the best standard of care according to the investigator's discretion. Down-titration of ESL as required should be performed in steps of 400 mg decrease per week
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ESL 800 mg | Experimental | Drug: ESL 800 mgESL will be administered orally once daily (QD) |
| ESL 1200 mg | Experimental | Drug: ESL 1200 mgESL will be administered orally once daily (QD) |
| ESL 1600 mg | Experimental | Drug: ESL 1600 mgESL will be administered orally once daily (QD) |
| ESL 400 mg | Experimental | Drug: ESL 400 mgESL will be administered orally once daily (QD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For inclusion in the extension study, subjects must fulfill all of the following at Visit 1 (Day 1, start of the open-label extension study):
- Participated in the preceding double-blind study and were still ongoing at the time of unblinding.
- Have signed informed consent before undergoing any activities related to the open-label extension study.
- Demonstrated cooperation and willingness to complete all aspects of the study.
- Female subjects without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative serum ß-human chorionic gonadotropin (hCG) test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the Post-study Visit (PSV).
Key exclusion criteria (9 listed)
- Excluded from the double-blind study due to seizure in the Maintenance or Extension Phase, or at dose level C (either CBZ-CR or ESL), or discontinued prematurely due to any other reason in the double-blind study.
- Presence of any major protocol violation during the double-blind study which may have an impact on the compliance during this extension study.
- Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide-Severity Rating Scale (C-SSRS).
- Occurrence of an adverse event (AE) indicating a suspected presence of atrioventricular block (2nd degree and above) or of any other AEs during the double-blind study which are judged by the investigator as contraindicative to further participation in the open-label extension study.
- Events of alcohol, drug, or medication abuse during the preceding double-blind study.
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 |
|---|---|---|
| ESL 800 mgAlso: BIA 2-093one (1) tablet of 800 mg (QD). | Drug | ESL 800 mg |
| ESL 1200 mgAlso: BIA 2-093one (1) and a half tablets of 800 mg (QD). ESL tablets are scored and can be divided in two equal halves (each one containing 400 mg ESL) | Drug | ESL 1200 mg |
| ESL 1600 mgAlso: BIA 2-093two (2) tablets of 800 mg (QD). | Drug | ESL 1600 mg |
| ESL 400 mgAlso: BIA 2-093half tablet of 800 mg (QD). ESL tablets are scored and can be divided in two equal halves (each one containing 400 mg ESL) | Drug | ESL 400 mg |
Primary outcome
Time to treatment failure
Time frame: up to 2 years
Time to treatment failure, defined as time from start of open-label ESL treatment at Visit 1 until withdrawal due to AE or due to lack of efficacy (i.e. inadequate seizure control), is the primary endpoint of this study. Open-label ESL treatment will be provided for approximately 2 years. Regular Treatment Visits (TVs) will be performed every 3 months after start of treatment.
1 secondary outcome
Number of Adverse Events (AEs) reported by patient
Time frame: participants will be followed for the duration of the clinical trial, an expected average of 2 years
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 16 Oct 2018.
- Derived from this study: PubMed 37675038Trinka E, Rocamora R, Chaves J, Koepp MJ, Ruegg S, Holtkamp M, Moreira J, Fonseca MM, Castilla-Fernandez G, Ikedo F. Lipid profile with eslicarbazepine acetate and carbamazepine monotherapy in adult patients with newly diagnosed focal seizures: post hoc analysis of a phase III trial and open-label extension study. Ther Adv Neurol Disord. 2023 Sep 4;16:17562864231193530. doi: 10.1177/17562864231193530. eCollection 2023.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ESL 800 mg, ESL 1200 mg and ESL 1600 mg in people with Epilepsy, run by Bial - Portela C S.A..
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 9 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to treatment failure (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484001, which also lists 1 linked publication.
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 16 Oct 2018.