EpilepsyPhase 1NCT02283801
Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine.
A Phase 1 study testing Eslicarbazepine acetate and Lamotrigine 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?
- Eslicarbazepine acetate and Lamotrigine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jan 2007
- Phase
- Phase 1
- 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 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 rears 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; if 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 examination
- Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day I of thi s study The informed consent form must be signed by all volunteers, prior to their participation in the study.
Who cannot join
- Significant history of hypersensitivity to lamotrigine, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver 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 or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
- Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
- Presence of significant heart disease or disorder according to ECG
- Presence or history of significant central nervous system disorder like convulsion or depression
- Presence or history of significant ocular disease
- 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).
About this study
Official title: A Phase 1, Open-label Drug Interaction Study Between Eslicarbazepine Acetate 1200mg and Lamotrigine 150mg Following Multiple Doses Administrations in Healthy Male Volunteers
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 Lamotrigine (LMT) in last phases; Group B: Pre-treatment with LMT, treatment with LMT and ascending doses of ESL in last phases
- Conditions
- Epilepsy
- Being tested
- Eslicarbazepine acetate, Lamotrigine
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eslicarbazepine acetateDrug
Also called ESL
LamotrigineDrug
Also called LMT
| Study group | Role | What they receive |
|---|---|---|
| Group A | 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 lamotrigine 50 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and lamotrigine 150 mg for seventeen consecutive days Receives: Drug: Eslicarbazepine acetate; Drug: Lamotrigine |
| Group B | Experimental | Group B
* Pre-treatment: 50 mg once daily dose of lamotrige (LMT) administered for two consecutive days;
* Treatment: 150 mg once daily dose of lamotrige (LMT) administered for six consecutive days;
* Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1600 mg and lamotrigine 150 mg for two consecutive days
* Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and lamotrigine 150 mg for seventeen consecutive days Receives: Drug: Eslicarbazepine acetate; Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - the maximum plasma concentration
Measured: 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
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time
Measured: 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)
tmax - the time of occurrence of Cmax
Measured: 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 startNov 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- NCT02283801
- Sponsor's protocol ID
- BIA-2093-119
- Status last verified
- Nov 2014
- First submitted
- 3 Nov 2014
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. 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 1200mg and Lamotrigine 150mg Following Multiple Doses Administrations in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02283801
- Acronym / sponsor ID
- BIA-2093-119
- 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
- Nov 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 5 Nov 2014 (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.
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 Lamotrigine (LMT) in last phases; Group B: Pre-treatment with LMT, treatment with LMT 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 | Experimental | Drug: Eslicarbazepine acetate, Drug: LamotrigineGroup 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 lamotrigine 50 mg for two consecutive days * Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and lamotrigine 150 mg for seventeen consecutive days |
| Group B | Experimental | Drug: Eslicarbazepine acetate, Drug: LamotrigineGroup B * Pre-treatment: 50 mg once daily dose of lamotrige (LMT) administered for two consecutive days; * Treatment: 150 mg once daily dose of lamotrige (LMT) administered for six consecutive days; * Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1600 mg and lamotrigine 150 mg for two consecutive days * Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and lamotrigine 150 mg 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 rears 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; if 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 examination
- Light-, non- or ex-smokers. A light smoker is defined as someone smoking 1 0 cigarettes or less per day, and an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day I of thi s study The informed consent form must be signed by all volunteers, prior to their participation in the study.
Key exclusion criteria (8 listed)
- Significant history of hypersensitivity to lamotrigine, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver 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 or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
- Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
- Presence of significant heart disease or 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 |
|---|---|---|
| Eslicarbazepine acetateAlso: ESL | Drug | Group A, Group B |
| LamotrigineAlso: LMT | Drug | Group A, Group B |
Primary outcome
Cmax - the maximum plasma concentration
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
AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time
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
1 secondary outcome
tmax - the time of occurrence of Cmax
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
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 5 Nov 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eslicarbazepine acetate and Lamotrigine 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 8 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 5 Nov 2014. 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?
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?
Cmax - the maximum plasma concentration (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 5 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.