Trial Outcomes & Findings for Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization (NCT NCT02283788)
NCT ID: NCT02283788
Last Updated: 2025-04-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
67 participants
Primary outcome timeframe
-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose
Results posted on
2025-04-11
Participant Flow
Participant milestones
| Measure |
Treatment Sequence ABCD
Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
|
Treatment Sequence BDAC
Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
|
Treatment Sequence CADB
Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
|
Treatment Sequence DCBA
Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
17
|
16
|
|
Overall Study
COMPLETED
|
16
|
13
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
5
|
2
|
Reasons for withdrawal
| Measure |
Treatment Sequence ABCD
Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
|
Treatment Sequence BDAC
Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
|
Treatment Sequence CADB
Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
|
Treatment Sequence DCBA
Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization
Baseline characteristics by cohort
| Measure |
Treatment Sequence ABCD
n=17 Participants
A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days
BIA 2-093
Moxifloxacin
Placebo
|
Treatment Sequence BDAC
n=17 Participants
A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days
BIA 2-093
Moxifloxacin
Placebo
|
Treatment Sequence CADB
n=17 Participants
A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days
BIA 2-093
Moxifloxacin
Placebo
|
Treatment Sequence DCBA
n=16 Participants
A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days
BIA 2-093
Moxifloxacin
Placebo
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 7.55 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 6.41 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 7.88 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 7.35 • n=4 Participants
|
34.5 years
STANDARD_DEVIATION 7.31 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: -30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-doseOutcome measures
| Measure |
BIA 2-093 1200 mg
n=61 Participants
ESL, Eslicarbazepine 1200 mg
|
BIA 2-093 2400 mg
n=58 Participants
ESL, Eslicarbazepine 1200 mg
|
Moxifloxacin 400 mg
n=61 Participants
brand names Avelox, Avalox, and Avelon
|
Placebo
n=64 Participants
Placebo, PLC
|
|---|---|---|---|---|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
0.5 hr
|
-8.05 msec
Standard Deviation 12.168
|
-6.15 msec
Standard Deviation 10.891
|
-2.77 msec
Standard Deviation 10.496
|
-4.39 msec
Standard Deviation 9.985
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
1 hour
|
-9.34 msec
Standard Deviation 11.399
|
-7.34 msec
Standard Deviation 11.822
|
3.80 msec
Standard Deviation 11.824
|
-4.14 msec
Standard Deviation 9.515
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
1.5 hours
|
-8.70 msec
Standard Deviation 11.689
|
-8.67 msec
Standard Deviation 10.525
|
5.30 msec
Standard Deviation 11.537
|
-4.22 msec
Standard Deviation 10.432
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
2 hours
|
-9.48 msec
Standard Deviation 10.692
|
-8.31 msec
Standard Deviation 10.738
|
6.87 msec
Standard Deviation 11.477
|
-5.32 msec
Standard Deviation 10.189
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
3 hours
|
-8.04 msec
Standard Deviation 11.188
|
-8.50 msec
Standard Deviation 13.142
|
8.49 msec
Standard Deviation 12.875
|
-3.24 msec
Standard Deviation 11.178
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
4 hours
|
-7.72 msec
Standard Deviation 12.496
|
-6.16 msec
Standard Deviation 13.563
|
10.13 msec
Standard Deviation 11.686
|
-2.10 msec
Standard Deviation 9.899
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
5 hours
|
-3.54 msec
Standard Deviation 11.282
|
-1.71 msec
Standard Deviation 12.567
|
7.07 msec
Standard Deviation 11.309
|
-0.75 msec
Standard Deviation 10.090
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
6 hours
|
-4.59 msec
Standard Deviation 11.792
|
-2.64 msec
Standard Deviation 12.856
|
5.83 msec
Standard Deviation 10.927
|
-3.10 msec
Standard Deviation 10.537
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
8 hours
|
-2.63 msec
Standard Deviation 10.841
|
-1.36 msec
Standard Deviation 11.281
|
5.80 msec
Standard Deviation 12.303
|
-1.77 msec
Standard Deviation 10.586
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
12 hours
|
-0.01 msec
Standard Deviation 9.347
|
0.03 msec
Standard Deviation 13.311
|
5.85 msec
Standard Deviation 9.955
|
-1.44 msec
Standard Deviation 9.150
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
16 hours
|
-3.72 msec
Standard Deviation 10.863
|
-4.65 msec
Standard Deviation 12.930
|
5.21 msec
Standard Deviation 10.900
|
-1.41 msec
Standard Deviation 12.835
|
|
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
23.5 hours
|
-3.36 msec
Standard Deviation 11.514
|
-0.06 msec
Standard Deviation 12.605
|
2.39 msec
Standard Deviation 9.104
|
-1.71 msec
Standard Deviation 9.513
|
SECONDARY outcome
Timeframe: -30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-doseOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: -30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-doseOutcome measures
Outcome data not reported
Adverse Events
Treatment Sequence ABCD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Sequence BDAC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment Sequence CADB
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Sequence DCBA
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 |
Treatment Sequence ABCD
n=17 participants at risk
Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
|
Treatment Sequence BDAC
n=17 participants at risk
Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
|
Treatment Sequence CADB
n=17 participants at risk
Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
|
Treatment Sequence DCBA
n=16 participants at risk
Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17
|
5.9%
1/17
|
0.00%
0/17
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17
|
0.00%
0/17
|
5.9%
1/17
|
6.2%
1/16
|
|
Gastrointestinal disorders
vomiting
|
5.9%
1/17
|
11.8%
2/17
|
11.8%
2/17
|
0.00%
0/16
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17
|
5.9%
1/17
|
11.8%
2/17
|
0.00%
0/16
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/17
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Nervous system disorders
dizziness
|
5.9%
1/17
|
17.6%
3/17
|
29.4%
5/17
|
6.2%
1/16
|
|
Nervous system disorders
Paraesthesia oral
|
0.00%
0/17
|
17.6%
3/17
|
17.6%
3/17
|
6.2%
1/16
|
|
Nervous system disorders
Somnolence
|
0.00%
0/17
|
11.8%
2/17
|
17.6%
3/17
|
6.2%
1/16
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Nervous system disorders
HEADACHE
|
5.9%
1/17
|
17.6%
3/17
|
29.4%
5/17
|
0.00%
0/16
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/17
|
0.00%
0/17
|
5.9%
1/17
|
6.2%
1/16
|
|
General disorders
Fatigue
|
0.00%
0/17
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Investigations
BLOOD PRESSURE INCREASED
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/17
|
0.00%
0/17
|
5.9%
1/17
|
0.00%
0/16
|
|
Vascular disorders
VASODILATATION
|
5.9%
1/17
|
0.00%
0/17
|
0.00%
0/17
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER