EpilepsyPhase 1NCT02284828
Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function
A Phase 1 study testing BIA 2-093 in people with Epilepsy, run by Bial - Portela C S.A..
Trial summary
Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- BIA 2-093
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Nov 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects, 18 to 45 years of age, inclusive
- Having completed at least high school level education (based on personal report)
- Native speakers of the English language or having learned English before 12 years of age
- Understood and provided written informed consent prior to the initiation of any protocol-specific procedures
- Body mass index (BMI) was within the range of 18 to 30 kg/m2, inclusive, with a minimum weight of at least 50 kg
- Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead ECG, and laboratory evaluation at Screening.
Show all 9Show fewer
- Female subjects of childbearing potential practiced abstinence or used and were willing to continue to use a medically acceptable form of birth control for at least 1 month prior to Screening and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception included intrauterine device or double-barrier. Hormone-based contraceptives methods were not acceptable, because ESL may have decreased their effectiveness. Female subjects of non-childbearing potential were amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
- Male subjects were required to use a double-barrier form of contraception
- Subjects who were willing and able to abide by all study requirements and restrictions
Who cannot join
- History or presence of drug or alcohol dependence (excluding nicotine and caffeine), including subjects who had ever been in a drug rehabilitation program, based on medical history
- Clinically significant abnormalities on physical examination, medical history, 12-lead ECG, vital signs, or laboratory values, as judged by the investigator or designee
- Current psychiatric illness, except nicotine and caffeine dependence. Subjects with a past history of psychiatric illness were excluded at the discretion of the investigator or designee
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition, which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results
- Use of a non-prescription drug within 7 days prior to the first study drug administration. Unless in the opinion of the investigator or designee, the medication received did not interfere with the study procedures or data integrity or compromise the safety of the subject
- Use of any prescription medications or natural health products (except acceptable forms of birth control and hormone replacement) within 14 days prior to the first study drug administration or throughout the study, unless in the opinion of the investigator or designee, the product did not interfere with the study procedures or data integrity or compromise the safety of the subject
Show all 15Show fewer
- Positive serum pregnancy screen following Screening or positive urine pregnancy screen at admission and on Days -1, 9, or 16
- Positive urine drug screen (5-panel MedTox kit) at Screening, Day -1, Day 9, or Day 16.
- Positive breath alcohol test at Screening, Days -1, 9, or 16
- Female subjects who were pregnant or lactating or who were planning to become pregnant within 60 days of last study drug administration
- History of allergy or hypersensitivity to ESL, related drugs, or any of the drug excipients or other drug product components
- Positive for Hepatitis B, Hepatitis C, or HIV
- Current or pending legal charges
- Treatment with any investigational drug within 30 days prior to first drug administration
- A subject who, in the opinion of the investigator or designee, was not considered to be suitable and was unlikely to comply with the study protocol for any reason
About this study
Official title: Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function: Single-blind, Single-centre, Single and Multiple Dose, Fixed-order, Placebocontrolled Trial in Healthy Volunteers
Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers.
Read the detailed description
Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers. A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg each given QD. The single dose was chosen to assess the ESL acute response relationship with respect to cognitive and motor skill performance, and the multiple doses were chosen to further characterize the ESL dose response relationship with respect to cognitive and motor skill performance.
- 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 ESL, Eslicarbazepine acetate
| Study group | Role | What they receive |
|---|---|---|
| Group 1 BIA 2-093 | Experimental | A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg. Receives: Drug: BIA 2-093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
Measured: -1, 3, 6, and 10 hours post-dose
Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Measured: -1, 3, 6, and 10 hours post-dose
Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
Measured: -1, 3, 6, and 10 hours post-dose
Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Measured: -1, 3, 6, and 10 hours post-dose
Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Measured: -1, 3, 6, and 10 hours post-dose
Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
Measured: -1, 3, 6, and 10 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 posted6 Nov 2014 (estimated)
- Study startSep 2007
- Primary completionNov 2007
- Study completionNov 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 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
- NCT02284828
- Sponsor's protocol ID
- BIA-2093-123
- Status last verified
- Dec 2014
- First submitted
- 4 Nov 2014
- Last updated
- 10 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function: Single-blind, Single-centre, Single and Multiple Dose, Fixed-order, Placebocontrolled Trial in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02284828
- Acronym / sponsor ID
- BIA-2093-123
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 10 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-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers.
Detailed description
Single-blind, single-centre, fixed-order study to evaluate the PD effects of a single oral dose and multiple oral doses of ESL (BIA 2-093) in healthy volunteers. A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg each given QD. The single dose was chosen to assess the ESL acute response relationship with respect to cognitive and motor skill performance, and the multiple doses were chosen to further characterize the ESL dose response relationship with respect to cognitive and motor skill performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 BIA 2-093 | Experimental | Drug: BIA 2-093A single dose of oral ESL 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female subjects, 18 to 45 years of age, inclusive
- Having completed at least high school level education (based on personal report)
- Native speakers of the English language or having learned English before 12 years of age
- Understood and provided written informed consent prior to the initiation of any protocol-specific procedures
- Body mass index (BMI) was within the range of 18 to 30 kg/m2, inclusive, with a minimum weight of at least 50 kg
Key exclusion criteria (15 listed)
- History or presence of drug or alcohol dependence (excluding nicotine and caffeine), including subjects who had ever been in a drug rehabilitation program, based on medical history
- Clinically significant abnormalities on physical examination, medical history, 12-lead ECG, vital signs, or laboratory values, as judged by the investigator or designee
- Current psychiatric illness, except nicotine and caffeine dependence. Subjects with a past history of psychiatric illness were excluded at the discretion of the investigator or designee
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition, which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results
- Use of a non-prescription drug within 7 days prior to the first study drug administration. Unless in the opinion of the investigator or designee, the medication received did not interfere with the study procedures or data integrity or compromise the safety of 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: ESL, Eslicarbazepine acetate | Drug | Group 1 BIA 2-093 |
Primary outcome
Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
Time frame: -1, 3, 6, and 10 hours post-dose
Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Time frame: -1, 3, 6, and 10 hours post-dose
Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
Time frame: -1, 3, 6, and 10 hours post-dose
Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Time frame: -1, 3, 6, and 10 hours post-dose
Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Time frame: -1, 3, 6, and 10 hours post-dose
Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
Time frame: -1, 3, 6, and 10 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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 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 9 inclusion and 15 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 10 Dec 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?
Yes. Results are posted in the registry (first posted 10 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?
Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase (time frame: -1, 3, 6, and 10 hours post-dose). The study lists 6 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 10 Dec 2014.