EpilepsyPhase 2NCT02170064
Pharmacokinetics, Efficacy and Tolerability of BIA 2-093
A Phase 2 study testing BIA 2-093 (Eslicarbazepine acetate) in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in Romania.
Trial summary
The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- BIA 2-093 (Eslicarbazepine acetate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteRomania
- Study dates
- Jun 2005to Apr 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The following inclusion criteria were applied in selecting patients for participation in the trial.
- Patient was eligible for entry into the baseline phase if he/she fulfilled the following criteria at Visit 1:
- Written informed consent given by the parent(s)/guardian(s), and by the patient when appropriate.
- Male or female patient aged between 2 and 17 years.
- Body weight within the 10th and 90th percentiles, by age and sex.
- A documented diagnosis of partial-onset seizures (simple or complex seizures with or without secondary generalisation), classified according to the International Classification of Epileptic Seizures.
Show all 17Show fewer
- Currently treated with 1 to 3 AEDs (any except OXC or CBZ), in a stable dosage regimen during at least 1 month prior to screening.
- Good general health (apart from epilepsy) based on medical history and physical examination.
- In case of a female patient, she was premenarchal, surgically sterile or presented a urine pregnancy test consistent with a non-gravid state and practiced an effective non-hormonal contraception method.
- At Visit 2, patient was eligible for entry into the Eslicarbazepine acetate treatment phase if he/she fulfilled the following criteria:
- At least 4 partial-onset seizures during the last 4 weeks of the baseline phase.
- Brain CT scan or MRI that excluded rapidly progressive neurological diseases.
- ECG without clinically significant abnormalities.
- Good general health (apart from epilepsy) based on medical history, physical examination and laboratory tests at screening.
- Diaries satisfactorily completed by the patient or his/her caregiver during the baseline phase.
- Satisfactory compliance with the study requirements during the baseline phase.
- In case of a female patient of childbearing potential, she presented a urine pregnancy test consistent with a non-gravid state and practiced an effective non-hormonal contraception method.
Who cannot join
- Patient was not allowed for entry into the screening phase if he/she fulfilled the following criteria at Visit 1:
- Primarily generalised epilepsy.
- Clinically relevant medical condition, other than epilepsy.
- History of status epilepticus in the last 3 months.
- History of suicide attempt.
- History of alcohol or drug abuse.
Show all 19Show fewer
- History of hypersensitivity or intolerance to OXC or CBZ.
- Use of any investigational drug or participated in any clinical trial within the previous 2 months.
- Patient and/or his/her caregiver(s) unlikely to co-operate with the requirements of the study.
- If female, she was sexually active and of child-bearing potential and she did not use reliable contraception.
- Patients with non-epileptic attacks (syncopes, pseudoseizures).
- Previous poor compliance with anti-epileptic therapy.
- Need for rescue benzodiazepines more frequently than twice per week on average.
- Previous use of Eslicarbazepine acetate or participation in a clinical study with Eslicarbazepine acetate.
- Any other condition or circumstance that, in the opinion of the investigator, might compromise the patient's ability to comply with the clinical trial protocol (CTP).
- At Visit 2, patient was not eligible for entry into the Eslicarbazepine acetate treatment phase if he/she fulfilled the following criteria:
- Inadequate compliance to concomitant AEDs during the baseline phase.
- Clinically relevant clinical laboratory test abnormalities at screening.
- Occurrence of any other condition or circumstance that, in the opinion of the investigator, might compromise the patient's ability to comply with the CTP.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Clinica de Neurologie Pediatrica, Spitalul "Alexandru Obregia"
Bucharest, 041914
About this study
Official title: Pharmacokinetics, Efficacy and Tolerability of BIA 2-093 in Children and Adolescents With Refractory Partial Epilepsy
The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.
Read the detailed description
This clinical study was planned to be performed as an open-label, single-centre, multiple-dose study, in 30 paediatric epileptic patients distributed by 3 age groups of 10 patients each: 2-6 years [Group 1], 7-11 years [Group 2], and 12-17 years [Group 3].
The study was constituted by a 4-week baseline phase, followed by 3 consecutive 4-week treatment periods with Eslicarbazepine acetate in which patients received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day (weeks 1-4), 15 mg/kg/day (weeks 5-8) and 30 mg/kg/day or 1800 mg/day, whichever less (weeks 9-12). At the end of each 4-week treatment period, patients were hospitalised and serial blood samples for drug assays were obtained over a dosing interval.
After the last treatment period or in the event of premature discontinuation, the dose had to be down-titrated during a 2-week period. After the last treatment period patient could continue receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s) /patient and his/her physician agreed this was in the best patient's interest. A follow-up visit occurred approximately 4 weeks after the last hospitalisation or early discontinuation.
- Conditions
- Epilepsy
- Being tested
- BIA 2-093 (Eslicarbazepine acetate)
- Keywords
- Epilepsy, BIA 2-093
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 2-093 (Eslicarbazepine acetate)Drug
Eslicarbazepine acetate administered at increasing daily doses of 5 mg/kg, 15 mg/kg, and 30 mg/kg (or 1800 mg, whichever less); once-daily; oral route
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (2-6 yrs) | Experimental | At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest.
For Group 1 (2-6 years), oral suspension 50 mg/mL was used. The dose was to be rounded to the nearest 25 mg unit. Receives: Drug: BIA 2-093 (Eslicarbazepine acetate) |
| Group 2 (7-11 years) | Experimental | At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest.
For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored). Receives: Drug: BIA 2-093 (Eslicarbazepine acetate) |
| Group 3 (12-17 years) | Experimental | At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest.
For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored). Receives: Drug: BIA 2-093 (Eslicarbazepine acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Drug Concentration (Cmax) Post-dose
Measured: pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose
Time of Occurrence of Cmax (Tmax).
Measured: pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose
Secondary outcomes (1)
Percentage Change in Seizure Frequency During Each 4-week Treatment Period Compared to the Baseline Phase
The efficacy variables were the percentage change in seizure frequency during each 4-week treatment period compared to the baseline phase.
Seizures were recorded in the patient's diary during the baseline phase and during the following 4-week treatment periods.
Seizure frequency for each patient was standardised to a frequency per 28 days period (i.e., mean daily frequency multiplied by 28). Changes in seizure frequency were analysed for each age group separately.
Measured: Baseline, end of 5 mg/kg/day treatment period (4 weeks), 15 mg/kg/day treatment period (4 weeks) and 30 mg/kg/day treatment period (4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT02170064
- Sponsor's protocol ID
- BIA-2093-202
- Status last verified
- Aug 2017
- First submitted
- 20 Jun 2014
- Last updated
- 20 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Efficacy and Tolerability of BIA 2-093 in Children and Adolescents With Refractory Partial Epilepsy
- ClinicalTrials.gov ID
- NCT02170064
- Acronym / sponsor ID
- BIA-2093-202
- Conditions
- Epilepsy
- Keywords
- Epilepsy, BIA 2-093
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 1 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.
Detailed description
This clinical study was planned to be performed as an open-label, single-centre, multiple-dose study, in 30 paediatric epileptic patients distributed by 3 age groups of 10 patients each: 2-6 years [Group 1], 7-11 years [Group 2], and 12-17 years [Group 3].
The study was constituted by a 4-week baseline phase, followed by 3 consecutive 4-week treatment periods with Eslicarbazepine acetate in which patients received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day (weeks 1-4), 15 mg/kg/day (weeks 5-8) and 30 mg/kg/day or 1800 mg/day, whichever less (weeks 9-12). At the end of each 4-week treatment period, patients were hospitalised and serial blood samples for drug assays were obtained over a dosing interval.
After the last treatment period or in the event of premature discontinuation, the dose had to be down-titrated during a 2-week period. After the last treatment period patient could continue receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s) /patient and his/her physician agreed this was in the best patient's interest. A follow-up visit occurred approximately 4 weeks after the last hospitalisation or early discontinuation.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (2-6 yrs) | Experimental | Drug: BIA 2-093 (Eslicarbazepine acetate)At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest. For Group 1 (2-6 years), oral suspension 50 mg/mL was used. The dose was to be rounded to the nearest 25 mg unit. |
| Group 2 (7-11 years) | Experimental | Drug: BIA 2-093 (Eslicarbazepine acetate)At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest. For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored). |
| Group 3 (12-17 years) | Experimental | Drug: BIA 2-093 (Eslicarbazepine acetate)At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9-12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate ("compassionate use") if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient's interest. For Group 2 (7-11 years) and Group 3 (12-17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored). |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- The following inclusion criteria were applied in selecting patients for participation in the trial.
- Patient was eligible for entry into the baseline phase if he/she fulfilled the following criteria at Visit 1:
- Written informed consent given by the parent(s)/guardian(s), and by the patient when appropriate.
- Male or female patient aged between 2 and 17 years.
- Body weight within the 10th and 90th percentiles, by age and sex.
Key exclusion criteria (19 listed)
- Patient was not allowed for entry into the screening phase if he/she fulfilled the following criteria at Visit 1:
- Primarily generalised epilepsy.
- Clinically relevant medical condition, other than epilepsy.
- History of status epilepticus in the last 3 months.
- History of suicide attempt.
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 |
|---|---|---|
| BIA 2-093 (Eslicarbazepine acetate)Eslicarbazepine acetate administered at increasing daily doses of 5 mg/kg, 15 mg/kg, and 30 mg/kg (or 1800 mg, whichever less); once-daily; oral route | Drug | Group 1 (2-6 yrs), Group 2 (7-11 years), Group 3 (12-17 years) |
Primary outcome
Maximum Observed Plasma Drug Concentration (Cmax) Post-dose
Time frame: pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose
Time of Occurrence of Cmax (Tmax).
Time frame: pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose
1 secondary outcome
Percentage Change in Seizure Frequency During Each 4-week Treatment Period Compared to the Baseline Phase
Time frame: Baseline, end of 5 mg/kg/day treatment period (4 weeks), 15 mg/kg/day treatment period (4 weeks) and 30 mg/kg/day treatment period (4 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A Phase 2 study testing BIA 2-093 (Eslicarbazepine acetate) in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in Romania.
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 17 inclusion and 19 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 20 Sep 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 Romania. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Observed Plasma Drug Concentration (Cmax) Post-dose (time frame: pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose). The study lists 2 primary outcomes in all. 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 20 Sep 2017.