EpilepsyPhase 1NCT02283814
A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate
A Phase 1 study testing BIA 2-093 and Topamax in people with Epilepsy, run by Bial - Portela C S.A..
Trial summary
Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy 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 and Topamax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Feb 2007
- 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
- Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
- Male aged of at least 18 years but not older than 45 years with a body mass índex (BMI) greater than or equal to 19 and below 30 kg/m
- Clinical laboratory values within the laboratory's stated normal range; i f not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
- Healthy according to the medical history, laboratory results and physical
- Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker i s defined as someone who completely stopped smoking for at least 1 2 months before day 1 of this study
Who cannot join
- Significant history of hypersensitivity to topiramate, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as wel l as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, l iver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver o r kidney disease, o r surgery that may affect drug bioavailability, including but not limited to cholecystectomy
- Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic d isease
- Presence o f significant heart disease o r disorder according to ECG
- Presence or history of significant central nervous system disorder l ike convulsion or depression
Show all 18Show fewer
- Presence o r history o f significant ocular disease
- Presence or history of severe hepatic impairment
- Presence or history of renal insufficiency (serum creatinine level greater than 135 μmol/L)
- History or presence of acidosis
- Use of valproic acid in the previous 7 days prior to Day 1 of the study.
- Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before Day 1 of this study
- Participation in another clinical trial or donation of 50 mL or more of blood in the previous 28 days before day 1 of this study
- Donation of 500 mL or more of blood (Canadian B lood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
- Positive urine screening of drugs of abuse (drugs listing is presented in section 6.1.1.4).
- Positive results to HIV, HBsAg or anti-HCV tests
About this study
Official title: A Phase-1, Open-label, Drug Interaction Study Between Eslicarbazepine Acetate 1200 mg and Topiramate 200 mg Following Multiple Dose Administrations in Healthy Male
Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers
Read the detailed description
Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of Topamax (TPM) in last phases; Group B: Pre-treatment with TPM, treatment with TPM and ascending doses of ESL in last phases
- Conditions
- Epilepsy
- Being tested
- BIA 2-093, Topamax
- 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 ESL, Eslicarbazepine acetate
TopamaxDrug
Also called TPM
| Study group | Role | What they receive |
|---|---|---|
| Group A BIA 2-093 + Topamax | Experimental | Group A
* Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;
* Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days
* Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days Receives: Drug: BIA 2-093; Drug: Topamax |
| Group B BIA 2-093 + Topamax | Experimental | * Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;
* Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;
* Treatment: 200 mg once daily dose of TPM administered for four consecutive days;
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days Receives: Drug: BIA 2-093; Drug: Topamax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - the Maximum Plasma Concentration
BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate
Measured: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
Tmax - the Time of Occurrence of Cmax
BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate Both Groups A and B described in participant flow recieved BIA 2-093 and Topiramate. The results presented here are related with the different interventions in both groups
Measured: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
Secondary outcomes (1)
AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.
BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate
Measured: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startJan 2007
- Primary completionFeb 2007
- Study completionFeb 2007
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
- None (open label)
- Enrolment
- 32 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
- NCT02283814
- Sponsor's protocol ID
- BIA-2093-120
- Status last verified
- Mar 2025
- First submitted
- 3 Nov 2014
- Last updated
- 11 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-1, Open-label, Drug Interaction Study Between Eslicarbazepine Acetate 1200 mg and Topiramate 200 mg Following Multiple Dose Administrations in Healthy Male
- ClinicalTrials.gov ID
- NCT02283814
- Acronym / sponsor ID
- BIA-2093-120
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Posted 22 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, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers
Detailed description
Single centre, open-label, multiple doses, one-sequence design study in two parallel groups of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of Topamax (TPM) in last phases; Group B: Pre-treatment with TPM, treatment with TPM and ascending doses of ESL in last phases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A BIA 2-093 + Topamax | Experimental | Drug: BIA 2-093, Drug: TopamaxGroup A * Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days; * Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days * Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days * Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days * Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days |
| Group B BIA 2-093 + Topamax | Experimental | Drug: BIA 2-093, Drug: Topamax* Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days; * Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days; * Treatment: 200 mg once daily dose of TPM administered for four consecutive days; * Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days * Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
- Male aged of at least 18 years but not older than 45 years with a body mass índex (BMI) greater than or equal to 19 and below 30 kg/m
- Clinical laboratory values within the laboratory's stated normal range; i f not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
- Healthy according to the medical history, laboratory results and physical
- Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker i s defined as someone who completely stopped smoking for at least 1 2 months before day 1 of this study
Key exclusion criteria (18 listed)
- Significant history of hypersensitivity to topiramate, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as wel l as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, l iver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver o r kidney disease, o r surgery that may affect drug bioavailability, including but not limited to cholecystectomy
- Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic d isease
- Presence o f significant heart disease o r disorder according to ECG
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: ESL, Eslicarbazepine acetate | Drug | Group A BIA 2-093 + Topamax, Group B BIA 2-093 + Topamax |
| TopamaxAlso: TPM | Drug | Group A BIA 2-093 + Topamax, Group B BIA 2-093 + Topamax |
Primary outcome
Cmax - the Maximum Plasma Concentration
Time frame: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate
Tmax - the Time of Occurrence of Cmax
Time frame: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate Both Groups A and B described in participant flow recieved BIA 2-093 and Topiramate. The results presented here are related with the different interventions in both groups
1 secondary outcome
AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.
Time frame: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epilepsy
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
Recruiting
Mapping of Human Cognition
Epilepsy, Brain Tumor
RecruitingPhase 2/3
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
Juvenile Myoclonic Epilepsy
RecruitingPhase 3
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Primary Generalized Tonic-Clonic Seizures
Recruiting
HOBSCOTCH-YOUTH and Young Adults
Epilepsy, Cognitive Dysfunction, Cognitive Disorder
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 1 study testing BIA 2-093 and Topamax 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 18 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 11 Apr 2025. 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 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 22 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?
Cmax - the Maximum Plasma Concentration (time frame: Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h). 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 11 Apr 2025.