EpilepsyPhase 1NCT02281526
An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093
A Phase 1 study testing BIA 2-093 in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in South Africa.
Trial summary
Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit. All subjects were to be treated with study medication for 8 consecutive days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- BIA 2-093
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2005to Feb 2006
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females at least 18 years of age.
- Female subjects had to be post-menopausal, surgically sterilized or using a reliable non-hormonal method of contraception. Examples of reliable non-hormonal methods of contraception include tubal ligation, hysterectomy, intrauterine device, or a barrier method combined with a spermicide. Hormonal contraceptives were not allowed because the effect of BIA 2-093 on the metabolism of oral contraceptives was not yet known.
- Subjects suffering from a chronic illness, other than hepatic impairment, had to have a stable condition, regarded by the investigator as not able to influence the outcome of the study.
- For subjects to be included in Group 1, a stage of moderate hepatic impairment, the extent of which, as measured by the Child-Pugh classification, resulted in recruitment into the study (Group 1 only). This did not apply to subjects that were recruited into Group 2, whose liver functioning was to be normal.
- Body mass not less than 50 kg.
Who cannot join
- The receipt of any investigational drug within the 30 days prior to this trial.
- Clinically significant abnormal findings (as judged by the investigator) for the following parameters, except those consistent with findings in hepatic impairment: haematology, biochemistry, clotting profile, urinalysis, vital signs or ECG screening tests.
- A history or laboratory evidence of renal impairment and/or disease. Owing to the metabolic pathway of BIA 2-093, any degree of renal impairment would have had a confounding effect on the PK analysis.
- Positive test for Human Immunodeficiency Virus (HIV)-1 or HIV-2 antibodies, Hepatitis B surface antigen and Hepatitis C antibodies. HIV positive patients, and patients with Hepatitis B and C, generally have a below average, and in some cases a markedly decreased, level of health owing to the nature of the respective infections and the natural course of the diseases, both of which are often complicated by an array of opportunistic illnesses. Their ill health would be further worsened by the fact that the patients are hepatically impaired, which has its own, often debilitating, complications. If patients with HIV or Hepatitis B or C were included in the study, this could have led to statistical confusion when assessing the safety and tolerability parameters. This is because events reported by the subjects, which might be a part of the spectrum of complaints in HIV positive patients and Hepatitis B and C patients, would confound the safety and tolerability analysis. In addition, by administering the study medication to these patients, any AEs that might have occurred would add to the discomfort of the patient.
- A history of any illness that, in the opinion of the investigator and/or sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject.
- Any planned procedures and/or devices to be performed/added during the course of the study, which might influence the evaluation of the endpoints of the study.
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- Current addiction to alcohol as determined by the investigator.
- Use of any medication, prescribed or over-the-counter, except drugs indicated for the treatment of concomitant illnesses in subjects with moderate hepatic impairment, or if the drugs would not have affected the outcome of the study in the opinion of the investigator. Vitamin use was allowed, but should have been stable during the course of the study.
- Current treatment with oxcarbazepine.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Subjects with a supine pulse rate at screening, after resting for 5 min, outside the range of 50 - 100 beats per minute (bpm).
- A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions.
- Known or suspected allergy to trial product or related products (e.g carbamazepine or oxcarbazepine).
- Female subjects who were pregnant or lactating.
- Previous participation in (recruitment into) this trial.
- Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before dose administration.
- Any history of a bleeding tendency, or an active bleed in the preceding 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093 in Subjects With Moderate Hepatic Impairment.
Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit. All subjects were to be treated with study medication for 8 consecutive days. Blood and urine were collected for the PK analysis, and safety assessments were performed.
Read the detailed description
The screening visit was performed 2 to 21 days before the first administration of study medication, the treatment phase consisted of 12 days (of which study medication was administered during the first 8 days), and the follow-up visit was performed 15 to 19 days after the first administration of study medication.
- Conditions
- Epilepsy
- Being tested
- 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 2-093Drug
Also called Eslicarbazepine Acetate
| Study group | Role | What they receive |
|---|---|---|
| Subjects with moderate hepatic impairment | Other | This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls Receives: Drug: BIA 2-093 |
| subjects - healthy controls | Other | This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls Receives: Drug: BIA 2-093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).
Day 1 - Area under the plasma concentration versus time curve, AUC(0-tlast).
BIA 2-194, 2-195 Glucoronide, Oxcarbazepine, BIA 2-093 Glucoronide, 2-194 Glucoronide are BIA 2-093 metabolites.
Measured: pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.
Secondary outcomes (1)
Cmax - Peak Plasma Concentration
Day 1 - Cmax Peak plasma concentration
Measured: pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startMay 2005
- Primary completionFeb 2006
- Study completionFeb 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 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT02281526
- Sponsor's protocol ID
- BIA-2093-111
- Status last verified
- Jan 2015
- First submitted
- 30 Oct 2014
- Last updated
- 12 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093 in Subjects With Moderate Hepatic Impairment.
- ClinicalTrials.gov ID
- NCT02281526
- Acronym / sponsor ID
- BIA-2093-111
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Posted 12 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit. All subjects were to be treated with study medication for 8 consecutive days. Blood and urine were collected for the PK analysis, and safety assessments were performed.
Detailed description
The screening visit was performed 2 to 21 days before the first administration of study medication, the treatment phase consisted of 12 days (of which study medication was administered during the first 8 days), and the follow-up visit was performed 15 to 19 days after the first administration of study medication.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with moderate hepatic impairment | Other | Drug: BIA 2-093This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls |
| subjects - healthy controls | Other | Drug: BIA 2-093This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females at least 18 years of age.
- Female subjects had to be post-menopausal, surgically sterilized or using a reliable non-hormonal method of contraception. Examples of reliable non-hormonal methods of contraception include tubal ligation, hysterectomy, intrauterine device, or a barrier method combined with a spermicide. Hormonal contraceptives were not allowed because the effect of BIA 2-093 on the metabolism of oral contraceptives was not yet known.
- Subjects suffering from a chronic illness, other than hepatic impairment, had to have a stable condition, regarded by the investigator as not able to influence the outcome of the study.
- For subjects to be included in Group 1, a stage of moderate hepatic impairment, the extent of which, as measured by the Child-Pugh classification, resulted in recruitment into the study (Group 1 only). This did not apply to subjects that were recruited into Group 2, whose liver functioning was to be normal.
- Body mass not less than 50 kg.
Key exclusion criteria (17 listed)
- The receipt of any investigational drug within the 30 days prior to this trial.
- Clinically significant abnormal findings (as judged by the investigator) for the following parameters, except those consistent with findings in hepatic impairment: haematology, biochemistry, clotting profile, urinalysis, vital signs or ECG screening tests.
- A history or laboratory evidence of renal impairment and/or disease. Owing to the metabolic pathway of BIA 2-093, any degree of renal impairment would have had a confounding effect on the PK analysis.
- Positive test for Human Immunodeficiency Virus (HIV)-1 or HIV-2 antibodies, Hepatitis B surface antigen and Hepatitis C antibodies. HIV positive patients, and patients with Hepatitis B and C, generally have a below average, and in some cases a markedly decreased, level of health owing to the nature of the respective infections and the natural course of the diseases, both of which are often complicated by an array of opportunistic illnesses. Their ill health would be further worsened by the fact that the patients are hepatically impaired, which has its own, often debilitating, complications. If patients with HIV or Hepatitis B or C were included in the study, this could have led to statistical confusion when assessing the safety and tolerability parameters. This is because events reported by the subjects, which might be a part of the spectrum of complaints in HIV positive patients and Hepatitis B and C patients, would confound the safety and tolerability analysis. In addition, by administering the study medication to these patients, any AEs that might have occurred would add to the discomfort of the patient.
- A history of any illness that, in the opinion of the investigator and/or sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject.
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 2-093Also: Eslicarbazepine Acetate | Drug | Subjects with moderate hepatic impairment, subjects - healthy controls |
Primary outcome
Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).
Time frame: pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.
Day 1 - Area under the plasma concentration versus time curve, AUC(0-tlast). BIA 2-194, 2-195 Glucoronide, Oxcarbazepine, BIA 2-093 Glucoronide, 2-194 Glucoronide are BIA 2-093 metabolites.
1 secondary outcome
Cmax - Peak Plasma Concentration
Time frame: pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
- 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 1 study testing BIA 2-093 in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in South Africa.
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 17 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 Jan 2015. 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 South Africa. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 12 Jan 2015). 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?
Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast). (time frame: pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.). 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 Jan 2015; AzTrials last refreshed its copy on 26 Oct 2026.