Trial Outcomes & Findings for Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function (NCT NCT02284828)
NCT ID: NCT02284828
Last Updated: 2014-12-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
-1, 3, 6, and 10 hours post-dose
Results posted on
2014-12-10
Participant Flow
Participant milestones
| Measure |
Group 1 BIA 2-093
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function
Baseline characteristics by cohort
| Measure |
Group 1 BIA 2-093
n=26 Participants
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: -1, 3, 6, and 10 hours post-doseOutcome measures
| Measure |
Group 1 BIA 2-093
n=22 Participants
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
|
|---|---|
|
Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
3 hours
|
4.1 miliseconds
Standard Deviation 69.22
|
|
Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
6 hours
|
0.7 miliseconds
Standard Deviation 66.37
|
|
Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
10 hours
|
-10.8 miliseconds
Standard Deviation 52.96
|
PRIMARY outcome
Timeframe: -1, 3, 6, and 10 hours post-doseOutcome measures
| Measure |
Group 1 BIA 2-093
n=22 Participants
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
|
|---|---|
|
Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Pre-dose
|
587.0 miliseconds
Standard Deviation 118.51
|
|
Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
3 hours
|
590.3 miliseconds
Standard Deviation 89.91
|
|
Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
6 hours
|
588.2 miliseconds
Standard Deviation 94.12
|
|
Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
10 hours
|
576.5 miliseconds
Standard Deviation 106.46
|
PRIMARY outcome
Timeframe: -1, 3, 6, and 10 hours post-doseOutcome measures
| Measure |
Group 1 BIA 2-093
n=22 Participants
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
|
|---|---|
|
Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
3 hours
|
-11.1 miliseconds
Standard Deviation 55.23
|
|
Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
6 hours
|
-9.2 miliseconds
Standard Deviation 54.67
|
|
Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
10 hours
|
-19.3 miliseconds
Standard Deviation 51.05
|
PRIMARY outcome
Timeframe: -1, 3, 6, and 10 hours post-doseOutcome measures
| Measure |
Group 1 BIA 2-093
n=22 Participants
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
|
|---|---|
|
Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Pre-dose
|
425.0 miliseconds
Standard Deviation 81.88
|
|
Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
3 hours
|
414.0 miliseconds
Standard Deviation 53.55
|
|
Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
6 hours
|
419.3 miliseconds
Standard Deviation 58.70
|
|
Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
10 hours
|
408.0 miliseconds
Standard Deviation 56.40
|
PRIMARY outcome
Timeframe: -1, 3, 6, and 10 hours post-doseOutcome measures
| Measure |
Group 1 BIA 2-093
n=22 Participants
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
|
|---|---|
|
Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
Pre-dose
|
1011.9 miliseconds
Standard Deviation 195.12
|
|
Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
3 hours
|
1004.3 miliseconds
Standard Deviation 134.68
|
|
Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
6 hours
|
1007.5 miliseconds
Standard Deviation 145.70
|
|
Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase
10 hours
|
984.5 miliseconds
Standard Deviation 157.72
|
PRIMARY outcome
Timeframe: -1, 3, 6, and 10 hours post-doseOutcome measures
| Measure |
Group 1 BIA 2-093
n=22 Participants
A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
|
|---|---|
|
Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
3 hours
|
-7.0 miliseconds
Standard Deviation 119.95
|
|
Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
6 hours
|
-8.4 miliseconds
Standard Deviation 117.00
|
|
Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase
10 hours
|
-30.0 miliseconds
Standard Deviation 99.67
|
Adverse Events
BIA 2-093 900 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
BIA 2-093 800 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BIA 2-093 1200 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 2-093 900 mg
n=26 participants at risk
BIA 2-093 - ESL, Eslicarbazepine acetate
|
Placebo
n=26 participants at risk
Placebo, PLC
|
BIA 2-093 800 mg
n=26 participants at risk
BIA 2-093 - ESL, Eslicarbazepine acetate
|
BIA 2-093 1200 mg
n=26 participants at risk
BIA 2-093 - ESL, Eslicarbazepine acetate
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/26
|
7.7%
2/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26
|
19.2%
5/26
|
11.5%
3/26
|
0.00%
0/26
|
|
Nervous system disorders
Headache
|
3.8%
1/26
|
3.8%
1/26
|
7.7%
2/26
|
7.7%
2/26
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
7.7%
2/26
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
7.7%
2/26
|
|
Nervous system disorders
Somnolence
|
7.7%
2/26
|
11.5%
3/26
|
0.00%
0/26
|
7.7%
2/26
|
|
Eye disorders
Erythema of eyelid
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Eye disorders
Vision blurred
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
1/26
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Stomach discomfort
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
|
General disorders
Asthenia
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
|
General disorders
Chest discomfort
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
|
General disorders
Fatigue
|
3.8%
1/26
|
3.8%
1/26
|
0.00%
0/26
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
|
Nervous system disorders
Dizziness
|
0.00%
0/26
|
3.8%
1/26
|
7.7%
2/26
|
3.8%
1/26
|
|
Nervous system disorders
Dysgeusia
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Nervous system disorders
Tremor
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/26
|
3.8%
1/26
|
3.8%
1/26
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
3.8%
1/26
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/26
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
0.00%
0/26
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26
|
0.00%
0/26
|
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