EpilepsyPhase 1NCT02305329

Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation

A Phase 1 study testing BIA 9-1067 in people with Epilepsy, run by Bial - Portela C S.A..

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 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Epilepsy
What is being tested?: BIA 9-1067
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: No sites listed yet
Study dates: Feb 2014to Apr 2014
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

Male or female subjects aged 18 to 45 years, inclusive;
Body mass index (BMI) between 19 and 30 kg/m²;
Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG; - Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C vírus (anti-HCV) antibodies, and anti-human immunodeficiency virus (HIV)-1/-2 antibodies at screening;
Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
Non-smokers or ex-smokers for at least 3 months;
Able and willing to give written informed consent;
If female: She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject) for all the duration of the study; and she had a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period.

Who cannot join

A clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
A clinically relevant surgical history;
Any clinically relevant abnormality in the coagulation tests;
Any clinically relevant abnormality in the liver function tests. If the subject had a borderline clinically relevant abnormality that was not considered clinically significant, a retest could be done after discussion with the sponsor's medical monitor;
A history of relevant atopy or drug hypersensitivity;
A history of alcoholism or drug abuse;

Show all 18Show fewer

Consume more than 14 units of alcohol a week;
A significant infection or known inflammatory process on screening or admission to each treatment period;
Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
Used medicines within 2 weeks of admission to first period that could have affected the subject's safety or other study assessments in the investigator's opinion;
Previously received OPC. Previous use of OPC was documented by questioning the subjects;
Used any investigational drug or participated in any clinical trial within 90 days prior to screening
Participated in more than 2 clinical trials within the 12 months prior to screening;
Donated or received any blood or blood products within the 3 months prior to screening;
Vegetarians, vegans or have medical dietary restrictions;
Not able to communicate reliably with the investigator;
Unlikely to co-operate with the requirements of the study; unwilling or unable to give written informed consent;
If female: she was pregnant or breast-feeding; she had a positive serum pregnancy test; she was of childbearing potential and did not use an accepted effective contraceptive method or she used oral contraceptives.

About this study

Official title: Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation in Healthy Subjects

Read the detailed description

Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more. In Group 1 the volunteers received a single oral dose of 25 mg OPC. In Group 2 the volunteers received a single oral dose of 50 mg OPC

Conditions: Epilepsy
Being tested: BIA 9-1067
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIA 9-1067Drug
Also called OPC, Opicapone

Study groups in NCT02305329
Study group	Role	What they receive
Group 1 BIA 9-1067 25 mg	Experimental	Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC Receives: Drug: BIA 9-1067
Group 2 BIA 9-1067 25 mg	Experimental	Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC Receives: Drug: BIA 9-1067
Group 1 BIA 9-1067 50 mg	Experimental	Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC Receives: Drug: BIA 9-1067
Group 2 BIA 9-1067 50 mg	Experimental	Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC Receives: Drug: BIA 9-1067

What is being measured

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

Cmax - Maximum Observed Plasma Concentration of 9-1067
Cmax - maximum observed plasma concentration of 9-1067.
Measured: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose

Secondary outcomes (3)

Tmax - Time of Occurrence of Cmax of 9-1067
tmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067
Measured: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t
Measured: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity.
Measured: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose

Timeline

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

Feb 2014Apr 2014

First posted2 Dec 2014 (estimated)
Study startFeb 2014
Primary completionApr 2014
Study completionApr 2014

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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02305329
Sponsor's protocol ID: BIA-91067-121
Status last verified: Jul 2015
First submitted: 28 Nov 2014
Last updated: 21 Aug 2015
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?

Official record

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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation in Healthy Subjects
ClinicalTrials.gov ID: NCT02305329
Acronym / sponsor ID: BIA-91067-121
Conditions: Epilepsy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 2 Dec 2014 (estimated)
Results: Posted 21 Aug 2015

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: 4

Arm	Type	Receives
Group 1 BIA 9-1067 25 mg	Experimental	Drug: BIA 9-1067Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC
Group 2 BIA 9-1067 25 mg	Experimental	Drug: BIA 9-1067Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC
Group 1 BIA 9-1067 50 mg	Experimental	Drug: BIA 9-1067Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC
Group 2 BIA 9-1067 50 mg	Experimental	Drug: BIA 9-1067Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Male or female subjects aged 18 to 45 years, inclusive;
Body mass index (BMI) between 19 and 30 kg/m²;
Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG; - Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C vírus (anti-HCV) antibodies, and anti-human immunodeficiency virus (HIV)-1/-2 antibodies at screening;
Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;

Key exclusion criteria (18 listed)

A clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
A clinically relevant surgical history;
Any clinically relevant abnormality in the coagulation tests;
Any clinically relevant abnormality in the liver function tests. If the subject had a borderline clinically relevant abnormality that was not considered clinically significant, a retest could be done after discussion with the sponsor's medical monitor;
A history of relevant atopy or drug hypersensitivity;

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 9-1067Also: OPC, Opicapone	Drug	Group 1 BIA 9-1067 25 mg, Group 1 BIA 9-1067 50 mg, Group 2 BIA 9-1067 25 mg, Group 2 BIA 9-1067 50 mg

Primary outcome

Cmax - Maximum Observed Plasma Concentration of 9-1067
Time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
Cmax - maximum observed plasma concentration of 9-1067.

3 secondary outcomes

Tmax - Time of Occurrence of Cmax of 9-1067
Time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t
Time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
Time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose

Results and safety

Results posted to the registry on 21 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 BIA 9-1067 25 mg	14	14
Group 2 BIA 9-1067 25 mg	14	13
Group 1 BIA 9-1067 50 mg	14	14
Group 2 BIA 9-1067 50 mg	14	14

Primary outcome: Cmax - Maximum Observed Plasma Concentration of 9-1067

Time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose. Mean (Standard Deviation). Unit: ng/mL

Measure	5x5mg BIA 9-1067 n = 27	1x25 mg BIA 9-1067 n = 28	2x25 mg BIA 9-1067 n = 28	1x50 mg BIA 9-1067 n = 28
Value	600 (221)	567 (222)	955 (297)	917 (426)

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
5x5mg BIA 9-1067	0 of 27 (0%)	7 of 27 (25.9%)	Not reported
1x25 mg BIA 9-1067	0 of 28 (0%)	11 of 28 (39.3%)	Not reported
2x25 mg BIA 9-1067	0 of 28 (0%)	12 of 28 (42.9%)	Not reported
1x50 mg BIA 9-1067	0 of 28 (0%)	15 of 28 (53.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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
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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 9-1067 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 8 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 21 Aug 2015. 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 21 Aug 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?

Cmax - Maximum Observed Plasma Concentration of 9-1067 (time frame: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose). 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 NCT02305329.

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 21 Aug 2015.