EpilepsyPhase 1NCT02171234
A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects 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 United Kingdom.
Trial summary
The purpose of this study is to investigate the safety and tolerability of multiple dose regimens of BIA 2-093 in healthy young 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2001to Jun 2001
- 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
- Adult males aged 18-45 years, with a body mass index (BMI) of 19-28 kg/m2.
- Subjects who were healthy as determined by pre-study medical history, physical examination, 12-lead ECG and EEG.
- Subjects who had clinical laboratory tests acceptable to the investigator.
- Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
- Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.
- Subjects who were non-smokers or previous smokers who had not smoked for at least 6 months.
- Subjects who were able and willing to give written informed consent.
Who cannot join
- Subjects who did not conform to the above inclusion criteria.
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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 (carbamazepine and
Show all 22Show fewer
- related compounds).
- Subjects who had a history of alcoholism.
- Subjects who had a history of drug abuse.
- Subjects who consumed more than 28 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening and/or admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
- Subjects who had an acute infection such as influenza at the time of screening and/or admission.
- Subjects who had used prescription drugs within 4 weeks of first dosing.
- Subjects who had used over the counter medication, excluding routine vitamins but including mega dose vitamin therapy, within one week of dosing.
- Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of admission to this study.
- Subjects who had donated and/or received any blood or blood products within 3 months prior to screening.
- Subjects who were vegetarians, vegans and/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.
- Subjects who were unwilling or unable to give written informed consent.
- Subjects who had previously received BIA 2-093.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093, in Young Healthy Male Volunteers.
The purpose of this study is to investigate the safety and tolerability of multiple dose regimens of BIA 2-093 in healthy young male volunteers
Read the detailed description
Single centre, Phase I, double-blind, randomised, placebo-controlled study investigating 4 multiple rising oral doses of BIA 2-093 in 4 groups of 8 young healthy male subjects. Within each group, 2 subjects were randomised to receive placebo and the remaining 6 subjects to receive BIA 2-093. No subject was a member of more than one group. The dose regimens investigated were: 200 mg b.i.d.(twice daily), 400 mg o.d.(once daily; this was changed from 400 mg b.i.d. in protocol amendment 1, on the basis of interim pharmacokinetic analysis of Group 1 data), 800 mg o.d, and 1200 mg o.d. BIA 2-093/placebo was administered orally once daily on Days 1-8, or twice a day (at 12-hour intervals) on Days 1-7 with a final dose in the morning of Day 8. The multiple dose regimens were to be investigated in ascending order. Progression to each higher dose level was only to occur if the previous dose level was deemed by the investigator and the sponsor to be safe and well tolerated.
- Conditions
- Epilepsy
- Being tested
- Placebo, BIA 2-093
- Keywords
- Epilepsy, BIA 2-093, Eslicarbazepine acetate
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called PLC, Placebo
BIA 2-093Drug
Also called ESL, Eslicarbazepine acetate
| Study group | Role | What they receive |
|---|---|---|
| Group 1- 200 mg b.i.d. (twice daily) | Experimental | BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. Receives: Drug: Placebo; Drug: BIA 2-093 |
| Group 2 - 400 mg b.i.d. | Experimental | BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. Receives: Drug: Placebo; Drug: BIA 2-093 |
| Group 3- 800 mg o.d. (once daily) | Experimental | BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. Receives: Drug: Placebo; Drug: BIA 2-093 |
| Group 4 - either 800 mg b.i.d or 1200 mg o.d. | Experimental | BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. Receives: Drug: Placebo; Drug: BIA 2-093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Adverse Events
Total Number of Adverse Events.
Measured: up to 20 weeks
Secondary outcomes (2)
Cmax
Cmax - Maximum observed plasma concentration
Measured: Day 1 and Day 8
AUC0-τ
AUC0-τ - Area under the plasma concentration time curve to last measurable time point
Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose
Measured: Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startFeb 2001
- Primary completionJun 2001
- Study completionJun 2001
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
- NCT02171234
- Sponsor's protocol ID
- BIA-2093-102
- Status last verified
- Dec 2014
- First submitted
- 20 Jun 2014
- Last updated
- 7 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 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093, in Young Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT02171234
- Acronym / sponsor ID
- BIA-2093-102
- Conditions
- Epilepsy
- Keywords
- Epilepsy, BIA 2-093, Eslicarbazepine acetate
- 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
- Feb 2001
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Posted 7 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and tolerability of multiple dose regimens of BIA 2-093 in healthy young male volunteers
Detailed description
Single centre, Phase I, double-blind, randomised, placebo-controlled study investigating 4 multiple rising oral doses of BIA 2-093 in 4 groups of 8 young healthy male subjects. Within each group, 2 subjects were randomised to receive placebo and the remaining 6 subjects to receive BIA 2-093. No subject was a member of more than one group. The dose regimens investigated were: 200 mg b.i.d.(twice daily), 400 mg o.d.(once daily; this was changed from 400 mg b.i.d. in protocol amendment 1, on the basis of interim pharmacokinetic analysis of Group 1 data), 800 mg o.d, and 1200 mg o.d. BIA 2-093/placebo was administered orally once daily on Days 1-8, or twice a day (at 12-hour intervals) on Days 1-7 with a final dose in the morning of Day 8. The multiple dose regimens were to be investigated in ascending order. Progression to each higher dose level was only to occur if the previous dose level was deemed by the investigator and the sponsor to be safe and well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1- 200 mg b.i.d. (twice daily) | Experimental | Drug: Placebo, Drug: BIA 2-093BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. |
| Group 2 - 400 mg b.i.d. | Experimental | Drug: Placebo, Drug: BIA 2-093BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. |
| Group 3- 800 mg o.d. (once daily) | Experimental | Drug: Placebo, Drug: BIA 2-093BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. |
| Group 4 - either 800 mg b.i.d or 1200 mg o.d. | Experimental | Drug: Placebo, Drug: BIA 2-093BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult males aged 18-45 years, with a body mass index (BMI) of 19-28 kg/m2.
- Subjects who were healthy as determined by pre-study medical history, physical examination, 12-lead ECG and EEG.
- Subjects who had clinical laboratory tests acceptable to the investigator.
- Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
- Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.
Key exclusion criteria (22 listed)
- Subjects who did not conform to the above inclusion criteria.
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, 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 |
|---|---|---|
| PlaceboAlso: PLC, Placebo | Drug | Group 1- 200 mg b.i.d. (twice daily), Group 2 - 400 mg b.i.d., Group 3- 800 mg o.d. (once daily), Group 4 - either 800 mg b.i.d or 1200 mg o.d. |
| BIA 2-093Also: ESL, Eslicarbazepine acetate | Drug | Group 1- 200 mg b.i.d. (twice daily), Group 2 - 400 mg b.i.d., Group 3- 800 mg o.d. (once daily), Group 4 - either 800 mg b.i.d or 1200 mg o.d. |
Primary outcome
Total Number of Adverse Events
Time frame: up to 20 weeks
Total Number of Adverse Events.
2 secondary outcomes
Cmax
Time frame: Day 1 and Day 8
AUC0-τ
Time frame: Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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 United Kingdom.
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 7 inclusion and 22 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 7 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 United Kingdom. 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 7 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?
Total Number of Adverse Events (time frame: up to 20 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 7 Jan 2015.