EpilepsyPhase 1NCT02281448

Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

A Phase 1 study testing BIA 2-093 and Contraceptives, Oral, Combined in people with Epilepsy, run by Bial - Portela C S.A. at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy
What is being tested?: BIA 2-093 and Contraceptives, Oral, Combined
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 sitePortugal
Study dates: Mar 2005to May 2005
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Pre-menopausal female;
Able and willing to give written informed consent;
Aged 18 to 40 years, inclusive;
Not pregnant or breast-feeding;
Body mass index (BMI) between 19 and 30 kg/m2, inclusive;
Healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ECG;

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Clinical laboratory tests with clinically acceptable results at screening and admission to the first period;
Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening;
Negative test for drugs of abuse at screening;
Non-smoker or smokes less than 10 cigarettes or equivalent per day;
Agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit;
Negative pregnancy test at screening and admission to the first period.

Who cannot join

Had any contra-indication to the use of oral contraceptives;
Had experienced notable adverse events while on any oral contraceptive;
Had a history of alcoholism or drug abuse;
Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
Had acute gastrointestinal symptoms at the time of screening or admission to the first period;
Had a significant infection or inflammatory process at the time of screening or admission to the first period;

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Had a relevant surgical history;
Had a relevant family history;
Had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine);
Had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period;
Consumed more than 14 units of alcohol a week;
Had participated in any clinical trial within 3 months prior to screening;
Had previously received BIA 2-093;
Had donated or received any blood or blood products within 2 months prior to screening;
Was unlikely to co-operate with the requirements of the study.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

BIAL - Portela & Cª, S.A.
S. Mamede Do Coronado, S. Mamede Do Coronado, 4045-457

Other trials in Portugal

About this study

Official title: Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers

Read the detailed description

Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 for 15 days separated by a washout period of at least 3 weeks.

Conditions: Epilepsy
Being tested: BIA 2-093, Contraceptives, Oral, Combined
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
Contraceptives, Oral, CombinedDrug

Study groups in NCT02281448
Study group	Role	What they receive
Treatment sequence A	Other	oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive Receives: Drug: BIA 2-093; Drug: Contraceptives, Oral, Combined
Treatment sequence B	Other	oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days Receives: Drug: BIA 2-093; Drug: Contraceptives, Oral, Combined

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
Measured: Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.

Secondary outcomes (3)

Cmax
Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
Measured: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
Tmax
Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
Measured: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
AUC0-t
AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
Measured: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005May 2005

First posted3 Nov 2014 (estimated)
Study startMar 2005
Primary completionMay 2005
Study completionMay 2005

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: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02281448
Sponsor's protocol ID: BIA-2093-114
Status last verified: Nov 2014
First submitted: 30 Oct 2014
Last updated: 3 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Volunteers
ClinicalTrials.gov ID: NCT02281448
Acronym / sponsor ID: BIA-2093-114
Conditions: Epilepsy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Mar 2005
Primary completion: May 2005 (actual)
Study completion: May 2005 (actual)
First posted: 3 Nov 2014 (estimated)
Results: Posted 3 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment sequence A	Other	Drug: BIA 2-093, Drug: Contraceptives, Oral, Combinedoral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive
Treatment sequence B	Other	Drug: BIA 2-093, Drug: Contraceptives, Oral, Combinedoral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Pre-menopausal female;
Able and willing to give written informed consent;
Aged 18 to 40 years, inclusive;
Not pregnant or breast-feeding;
Body mass index (BMI) between 19 and 30 kg/m2, inclusive;

Key exclusion criteria (15 listed)

Had any contra-indication to the use of oral contraceptives;
Had experienced notable adverse events while on any oral contraceptive;
Had a history of alcoholism or drug abuse;
Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
Had acute gastrointestinal symptoms at the time of screening or admission to the first period;

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	Drug	Treatment sequence A, Treatment sequence B
Contraceptives, Oral, Combined	Drug	Treatment sequence A, Treatment sequence B

Primary outcome

Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Time frame: Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.

3 secondary outcomes

Cmax
Time frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
Tmax
Time frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
AUC0-t
Time frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.

Results and safety

Results posted to the registry on 3 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence A	10	8
Treatment Sequence B	10	9

Primary outcome: Cmax - Maximum Observed Plasma BIA 2-194 Concentration

Time frame: Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.. Mean (Standard Deviation). Unit: ng/mL

Measure	Cmax (BIA 2-194) n = 17
Day 1	0.00 (0.00)
Day 2	8443 (1422)
Day 4	10691 (1736)
Day 6	10961 (1737)
Day 8	10175 (996)
Day 10	10332 (1470)
Day 12	10821 (1806)
Day 14	10670 (1447)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eslicarbazepine Acetate 1200 mg + Microginon®	1 of 20 (5%)	19 of 19 (100%)	Not reported
Microginon®	0 of 20 (0%)	5 of 18 (27.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsy

Not yet recruiting
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RecruitingPhase 3
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Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Active, not recruitingObservational study
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RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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 and Contraceptives, Oral, Combined 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 12 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 3 Dec 2014. 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. 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 3 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 - Maximum Observed Plasma BIA 2-194 Concentration (time frame: Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02281448.

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 3 Dec 2014.