Epilepsy
Conditions
Keywords
Eslicarbazepine acetate, BIA 2-093, Epilepsy
Brief summary
The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.
Detailed description
Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy male adult subjects. Within each group of eight subjects two subjects were randomised to receive placebo and the remaining six subjects were randomised to receive BIA 2-093. No subject was a member of more than one treatment group. Doses of 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg were investigated in ascending order. Progression to each dose occurred only after the previous dose level was deemed to be safe and well tolerated by the investigator and the sponsor.
Interventions
DRUGBIA 2-093
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
DRUGPlacebo
Identical placebo administered as oral tablets with 200 ml potable water.
Sponsors
Bial - Portela C S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
Adult males aged 18-35 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 who smoked less than 10 cigarettes (or equivalent) per day. * Subjects who were able and willing to give written informed consent.
Exclusion criteria
* 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 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Adverse Events | up to 20 weeks | An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo, PLC | 16 |
| Group 1 20 mg BIA 2-093 20mg or placebo. | 6 |
| Group 2 50 mg BIA 2-093 50mg or placebo | 6 |
| Group 3 100 mg BIA 2-093 100mg or placebo | 6 |
| Group 4 200 mg BIA 2-093 200mg or placebo | 6 |
| Group 5 400 mg BIA 2-093 or 400mg or placebo | 6 |
| Group 6 600 mg BIA 2-093 600mg or placebo | 6 |
| Group 7 900 mg BIA 2-093 900mg or placebo | 6 |
| Group 8 1200 mg BIA 2-093 1200mg or placebo | 6 |
| Total | 64 |
Baseline characteristics
| Characteristic | Placebo | Group 1 20 mg | Group 2 50 mg | Group 3 100 mg | Group 4 200 mg | Group 5 400 mg | Group 6 600 mg | Group 7 900 mg | Group 8 1200 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 64 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 16 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 16 | 4 / 6 | 2 / 6 | 3 / 6 | 2 / 6 | 1 / 6 | 1 / 6 | 1 / 6 | 3 / 6 |
| serious Total, serious adverse events | 0 / 16 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Total Number of Adverse Events
An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product
Time frame: up to 20 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Total Number of Adverse Events | AE of Mild Severity | 7 Number of Adverse Events |
| Placebo | Total Number of Adverse Events | AE of Moderate Severity | 0 Number of Adverse Events |
| Placebo | Total Number of Adverse Events | AE Considered Not Related to Treatment | 0 Number of Adverse Events |
| Placebo | Total Number of Adverse Events | AE Considered Possibly Related to Treatment | 7 Number of Adverse Events |
| Placebo | Total Number of Adverse Events | All Adverse Events | 7 Number of Adverse Events |
| Group 1 20 mg | Total Number of Adverse Events | AE of Moderate Severity | 2 Number of Adverse Events |
| Group 1 20 mg | Total Number of Adverse Events | AE of Mild Severity | 5 Number of Adverse Events |
| Group 1 20 mg | Total Number of Adverse Events | AE Considered Not Related to Treatment | 2 Number of Adverse Events |
| Group 1 20 mg | Total Number of Adverse Events | All Adverse Events | 7 Number of Adverse Events |
| Group 1 20 mg | Total Number of Adverse Events | AE Considered Possibly Related to Treatment | 5 Number of Adverse Events |
| Group 2 50 mg | Total Number of Adverse Events | AE of Mild Severity | 3 Number of Adverse Events |
| Group 2 50 mg | Total Number of Adverse Events | All Adverse Events | 3 Number of Adverse Events |
| Group 2 50 mg | Total Number of Adverse Events | AE Considered Not Related to Treatment | 0 Number of Adverse Events |
| Group 2 50 mg | Total Number of Adverse Events | AE of Moderate Severity | 0 Number of Adverse Events |
| Group 2 50 mg | Total Number of Adverse Events | AE Considered Possibly Related to Treatment | 3 Number of Adverse Events |
| Group 3 100 mg | Total Number of Adverse Events | AE Considered Not Related to Treatment | 0 Number of Adverse Events |
| Group 3 100 mg | Total Number of Adverse Events | AE of Mild Severity | 6 Number of Adverse Events |
| Group 3 100 mg | Total Number of Adverse Events | AE Considered Possibly Related to Treatment | 7 Number of Adverse Events |
| Group 3 100 mg | Total Number of Adverse Events | All Adverse Events | 7 Number of Adverse Events |
| Group 3 100 mg | Total Number of Adverse Events | AE of Moderate Severity | 1 Number of Adverse Events |
| Group 4 200 mg | Total Number of Adverse Events | All Adverse Events | 2 Number of Adverse Events |
| Group 4 200 mg | Total Number of Adverse Events | AE Considered Possibly Related to Treatment | 2 Number of Adverse Events |
| Group 4 200 mg | Total Number of Adverse Events | AE of Moderate Severity | 0 Number of Adverse Events |
| Group 4 200 mg | Total Number of Adverse Events | AE of Mild Severity | 2 Number of Adverse Events |
| Group 4 200 mg | Total Number of Adverse Events | AE Considered Not Related to Treatment | 0 Number of Adverse Events |
| Group 5 400 mg | Total Number of Adverse Events | AE of Moderate Severity | 0 Number of Adverse Events |
| Group 5 400 mg | Total Number of Adverse Events | AE of Mild Severity | 1 Number of Adverse Events |
| Group 5 400 mg | Total Number of Adverse Events | AE Considered Possibly Related to Treatment | 1 Number of Adverse Events |
| Group 5 400 mg | Total Number of Adverse Events | AE Considered Not Related to Treatment | 0 Number of Adverse Events |
| Group 5 400 mg | Total Number of Adverse Events | All Adverse Events | 1 Number of Adverse Events |
| Group 6 600 mg | Total Number of Adverse Events | AE of Mild Severity | 1 Number of Adverse Events |
| Group 6 600 mg | Total Number of Adverse Events | All Adverse Events | 1 Number of Adverse Events |
| Group 6 600 mg | Total Number of Adverse Events | AE Considered Not Related to Treatment | 0 Number of Adverse Events |
| Group 6 600 mg | Total Number of Adverse Events | AE Considered Possibly Related to Treatment | 1 Number of Adverse Events |
| Group 6 600 mg | Total Number of Adverse Events | AE of Moderate Severity | 0 Number of Adverse Events |
| Group 7 900 mg | Total Number of Adverse Events | AE Considered Possibly Related to Treatment | 2 Number of Adverse Events |
| Group 7 900 mg | Total Number of Adverse Events | All Adverse Events | 2 Number of Adverse Events |
| Group 7 900 mg | Total Number of Adverse Events | AE Considered Not Related to Treatment | 0 Number of Adverse Events |
| Group 7 900 mg | Total Number of Adverse Events | AE of Moderate Severity | 0 Number of Adverse Events |
| Group 7 900 mg | Total Number of Adverse Events | AE of Mild Severity | 2 Number of Adverse Events |
| Group 8 1200 mg | Total Number of Adverse Events | AE of Moderate Severity | 0 Number of Adverse Events |
| Group 8 1200 mg | Total Number of Adverse Events | AE of Mild Severity | 7 Number of Adverse Events |
| Group 8 1200 mg | Total Number of Adverse Events | AE Considered Possibly Related to Treatment | 3 Number of Adverse Events |
| Group 8 1200 mg | Total Number of Adverse Events | All Adverse Events | 7 Number of Adverse Events |
| Group 8 1200 mg | Total Number of Adverse Events | AE Considered Not Related to Treatment | 4 Number of Adverse Events |