EpilepsyPhase 1NCT01879345
A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers
A Phase 1 study testing BIA 2-093 - 1800 mg (Group 1) and BIA 2-093 - 2400 mg (Group 2) in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in Portugal.
Trial summary
Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- BIA 2-093 - 1800 mg (Group 1) and BIA 2-093 - 2400 mg (Group 2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2004to Dec 2004
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
- Subjects who had clinical laboratory tests within normal ranges at screening and admission.
- Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
- Subjects who were negative for drugs of abuse and alcohol at screening and admission.
- Subjects who were non-smokers or smoked less than 10 cigarettes or equivalent per day.
- Subjects who were able and willing to give written informed consent.
Who cannot join
- Subjects who did not conform to the above inclusion criteria, OR
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant atopy.
- Subjects who had a history of relevant drug hypersensitivity.
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- Subjects who had a history of alcoholism or drug abuse.
- Subjects who consumed more than 14 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening or admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
- Subjects who had used prescription or over-the-counter medication within 2 weeks of admission.
- Subjects who had used any investigational drug or participated in any clinical trial within 3 months of admission.
- Subjects who had previously received BIA 2-093.
- Subjects who had donated or received any blood or blood products within the previous 3 months prior to screening.
- Subjects who were vegetarians, vegans or had medical dietary restrictions.
- Subjects who could not communicate reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Human Pharmacology Unit - BIAL - Portela & Ca, S.A.
Trofa, Coronado (S.Romão E S. Mamede), 4745-457
About this study
Official title: A Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 in Healthy Volunteers
Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers
Read the detailed description
Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day multiple-dose period (Phase B). The multiple-dose phase started 96 h post single-dose. Progression to the 2400 mg dose (Group 2) only occurred if the 1800 mg dose (Group 1) was considered to be safe and well tolerated. An appropriate interval separated the investigation of the two groups in order to permit a timely review and evaluation of safety data.
Treatment consisted of a single-dose (Phase A) followed by a once-daily dose for 7 days (Phase B). Doses were prepared as follows: Group 1 = 3 tablets of BIA 2-093 600 mg plus 1 placebo tablet, or 4 placebo tablets; Group 2 = 4 tablets of BIA 2-093 600 mg, or 4 placebo tablets.
- Conditions
- Epilepsy
- Being tested
- BIA 2-093 - 1800 mg (Group 1), BIA 2-093 - 2400 mg (Group 2), Placebo
- Keywords
- Anticonvulsant
- 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 - 1800 mg (Group 1)Drug
Also called Eslicarbazepine acetate
3 tablets of BIA 2-093
BIA 2-093 - 2400 mg (Group 2)Drug
Also called Eslicarbazepine acetate
4 tablets of BIA 2-093 600 mg
PlaceboDrug
Also called sugar pills
placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| BIA 2-093 - 1800 mg (Group 1) | Experimental | 3 tablets of BIA 2-093 600 mg Receives: Drug: BIA 2-093 - 1800 mg (Group 1) |
| BIA 2-093 - 2400 mg (Group 2) | Experimental | 4 tablets of BIA 2-093 600 mg Receives: Drug: BIA 2-093 - 2400 mg (Group 2) |
| Placebo | Placebo comparator | placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events Reported
investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient
Measured: 3 weeks
Secondary outcomes (3)
Cmax - Maximum Observed Plasma Drug Concentration
Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093
Oxcarbazepine is a BIA 2-093 metabolite
Measured: Day 1 and Day 7
Tmax - the Time of Occurrence of Cmax
Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
Measured: Day 1 and Day 7
AUC0-τ
Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startOct 2004
- Primary completionDec 2004
- Study completionDec 2004
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel Vaz da Silva, MD, PhD, Principal investigator, Human Pharmacology Unit / BIAL - Portela & Ca, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879345
- Sponsor's protocol ID
- BIA-2093-113
- Status last verified
- Mar 2025
- First submitted
- 13 Jun 2013
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01879345
- Acronym / sponsor ID
- BIA-2093-113
- Conditions
- Epilepsy
- Keywords
- Anticonvulsant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Posted 30 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers
Detailed description
Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day multiple-dose period (Phase B). The multiple-dose phase started 96 h post single-dose. Progression to the 2400 mg dose (Group 2) only occurred if the 1800 mg dose (Group 1) was considered to be safe and well tolerated. An appropriate interval separated the investigation of the two groups in order to permit a timely review and evaluation of safety data.
Treatment consisted of a single-dose (Phase A) followed by a once-daily dose for 7 days (Phase B). Doses were prepared as follows: Group 1 = 3 tablets of BIA 2-093 600 mg plus 1 placebo tablet, or 4 placebo tablets; Group 2 = 4 tablets of BIA 2-093 600 mg, or 4 placebo tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIA 2-093 - 1800 mg (Group 1) | Experimental | Drug: BIA 2-093 - 1800 mg (Group 1)3 tablets of BIA 2-093 600 mg |
| BIA 2-093 - 2400 mg (Group 2) | Experimental | Drug: BIA 2-093 - 2400 mg (Group 2)4 tablets of BIA 2-093 600 mg |
| Placebo | Placebo comparator | Drug: Placeboplacebo tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male subjects aged between 18 and 45 years, inclusive.
- Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
- Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
- Subjects who had clinical laboratory tests within normal ranges at screening and admission.
- Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
Key exclusion criteria (17 listed)
- Subjects who did not conform to the above inclusion criteria, OR
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant atopy.
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 - 1800 mg (Group 1)Also: Eslicarbazepine acetate3 tablets of BIA 2-093 | Drug | BIA 2-093 - 1800 mg (Group 1) |
| BIA 2-093 - 2400 mg (Group 2)Also: Eslicarbazepine acetate4 tablets of BIA 2-093 600 mg | Drug | BIA 2-093 - 2400 mg (Group 2) |
| PlaceboAlso: sugar pillsplacebo tablets | Drug | Placebo |
Primary outcome
Number of Adverse Events Reported
Time frame: 3 weeks
investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient
3 secondary outcomes
Cmax - Maximum Observed Plasma Drug Concentration
Time frame: Day 1 and Day 7
Tmax - the Time of Occurrence of Cmax
Time frame: Day 1 and Day 7
AUC0-τ
Time frame: Day 1 and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- 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.
Manuel Vaz da Silva, MD, PhD principal investigator
Human Pharmacology Unit / BIAL - Portela & Ca, S.A.
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 - 1800 mg (Group 1) and BIA 2-093 - 2400 mg (Group 2) in people with 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 8 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 8 Apr 2025. 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. Some participants in this study may receive a placebo. 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 30 Dec 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?
Number of Adverse Events Reported (time frame: 3 weeks). 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 8 Apr 2025.