Trial Outcomes & Findings for A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers (NCT NCT01879332)
NCT ID: NCT01879332
Last Updated: 2014-12-19
Results Overview
Safety was evaluated through the recording and monitoring of adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
2 days
Results posted on
2014-12-19
Participant Flow
Participant milestones
| Measure |
BIA 2-093 3000 mg Once Daily
Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration
|
BIA 2-093 3600 mg Once Daily
Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration
|
Placebo
Matching placebo tablets for oral administration
Placebo: Matching placebo tablets for oral administration
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Matching placebo tablets for oral administration
Placebo: Matching placebo tablets for oral administration
|
BIA 2-093 3000 mg Once Daily
n=6 Participants
Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration
|
BIA 2-093 3600 mg Once Daily
n=6 Participants
Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 daysSafety was evaluated through the recording and monitoring of adverse events
Outcome measures
| Measure |
BIA 2-093 3000 mg Once Daily
n=6 Participants
Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration
|
BIA 2-093 3600 mg Once Daily
n=6 Participants
Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration
|
Placebo
n=4 Participants
Matching placebo tablets for oral administration
Placebo: Matching placebo tablets for oral administration
|
|---|---|---|---|
|
Number of Adverse Events Reported
Gastrointestinal AE
|
5 Number of adverse events reported
|
4 Number of adverse events reported
|
1 Number of adverse events reported
|
|
Number of Adverse Events Reported
Nervous system AE
|
6 Number of adverse events reported
|
6 Number of adverse events reported
|
1 Number of adverse events reported
|
|
Number of Adverse Events Reported
General and Administration Site Conditions AE
|
4 Number of adverse events reported
|
1 Number of adverse events reported
|
0 Number of adverse events reported
|
|
Number of Adverse Events Reported
Eye AE
|
1 Number of adverse events reported
|
1 Number of adverse events reported
|
0 Number of adverse events reported
|
|
Number of Adverse Events Reported
Skin and Subcutaneous Tissue AE
|
1 Number of adverse events reported
|
0 Number of adverse events reported
|
0 Number of adverse events reported
|
Adverse Events
BIA 2-093 3000 mg Once Daily
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BIA 2-093 3600 mg Once Daily
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 2-093 3000 mg Once Daily
n=6 participants at risk
Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration
|
BIA 2-093 3600 mg Once Daily
n=6 participants at risk
Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration
|
Placebo
n=4 participants at risk
Matching placebo tablets for oral administration
Placebo: Matching placebo tablets for oral administration
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
83.3%
5/6
|
83.3%
5/6
|
25.0%
1/4
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6
|
66.7%
4/6
|
25.0%
1/4
|
|
Nervous system disorders
Headache
|
50.0%
3/6
|
0.00%
0/6
|
0.00%
0/4
|
|
Nervous system disorders
Paraesthesia Oral
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/4
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6
|
50.0%
3/6
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
|
16.7%
1/6
|
25.0%
1/4
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal Distension
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dry Mouth
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/4
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/4
|
|
General disorders
Fatigue
|
66.7%
4/6
|
16.7%
1/6
|
0.00%
0/4
|
|
General disorders
Asthenia
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/4
|
|
Eye disorders
Vision Blurred
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/4
|
Additional Information
Head of Clinical Research
Bial - Portela & Cª, S.A.
Phone: +351 229 866 100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER