Trial Outcomes & Findings for Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine (NCT NCT02284854)
NCT ID: NCT02284854
Last Updated: 2015-01-08
Results Overview
Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
Day 7 to 35
Results posted on
2015-01-08
Participant Flow
Participant milestones
| Measure |
Group A
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
|
Group B
Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine
Baseline characteristics by cohort
| Measure |
Group A
n=23 Participants
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
|
Group B
n=20 Participants
Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + 400 mg twice-daily
|
Total
n=43 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
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7 to 35Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg
Outcome measures
| Measure |
Group A
n=18 Participants
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
|
|---|---|
|
Cmax (BIA 2-093) - the Maximum Plasma Concentration
Cmax ESL (D7 ESL 800mg)
|
18601 ng/mL
Standard Deviation 3164
|
|
Cmax (BIA 2-093) - the Maximum Plasma Concentration
Cmax ESL (D35 ESL 800mg)
|
14591 ng/mL
Standard Deviation 1800
|
PRIMARY outcome
Timeframe: Day 28 to 35Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg
Outcome measures
| Measure |
Group A
n=20 Participants
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
|
|---|---|
|
Cmax (CBZ) - the Maximum Plasma Concentration
Cmax CBZ (D28 CBZ 400 mg twice-daily)
|
10414 ng/mL
Standard Deviation 1896
|
|
Cmax (CBZ) - the Maximum Plasma Concentration
Cmax CBZ (D35 CBZ 400 mg twice-daily)
|
9719 ng/mL
Standard Deviation 2019
|
PRIMARY outcome
Timeframe: Day 28 to 35Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily CBZE - carbamazepine-epoxide is the active metabolite of CBZ
Outcome measures
| Measure |
Group A
n=20 Participants
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
|
|---|---|
|
Cmax (CBZE) - the Maximum Plasma Concentration
Cmax CBZE (D28 CBZ 400 mg twice-daily)
|
1562 ng/mL
Standard Deviation 429
|
|
Cmax (CBZE) - the Maximum Plasma Concentration
Cmax CBZE (D35 CBZ 400 mg twice-daily)
|
1560 ng/mL
Standard Deviation 332
|
PRIMARY outcome
Timeframe: Day 7 to 35Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg
Outcome measures
| Measure |
Group A
n=18 Participants
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
|
|---|---|
|
AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093
AUC0-t ESL (D7 ESL 800mg)
|
276836 ng*h/mL
Standard Deviation 43062
|
|
AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093
AUC0-t ESL (D35 ESL 800mg)
|
188648 ng*h/mL
Standard Deviation 23897
|
PRIMARY outcome
Timeframe: Day 28 to 35Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg
Outcome measures
| Measure |
Group A
n=20 Participants
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
|
|---|---|
|
AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ
AUC0-t CBZ (D28 CBZ 400 mg twice-daily)
|
104494 ng*h/mL
Standard Deviation 16344
|
|
AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ
AUC0-t CBZ (D35 CBZ 400 mg twice-daily)
|
94394 ng*h/mL
Standard Deviation 17230
|
PRIMARY outcome
Timeframe: Day 28 to 35Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg CBZE - carbamazepine-epoxide is the active metabolite of CBZ
Outcome measures
| Measure |
Group A
n=20 Participants
Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
|
|---|---|
|
AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE
AUC0-t CBZE (D28 CBZ 400 mg twice-daily)
|
15322 ng*h/mL
Standard Deviation 3857
|
|
AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE
AUC0-t CBZE (D35 CBZ 400 mg twice-daily)
|
14953 ng*h/mL
Standard Deviation 3121
|
Adverse Events
CBZ 200 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
CBZ 400 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
CBZ 400 mg Twice-daily
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
ESL 800 mg + CBZ 400 mg Twice-daily
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
ESL 800 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
ESL 800 mg + CBZ 200 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
ESL 800 mg + CBZ 400 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Before Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
After Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CBZ 200 mg
n=20 participants at risk
Group B CBZ 200 mg
|
CBZ 400 mg
n=20 participants at risk
Group B CBZ 400 mg
|
CBZ 400 mg Twice-daily
n=20 participants at risk
Group B CBZ 400 mg twice-daily
|
ESL 800 mg + CBZ 400 mg Twice-daily
n=39 participants at risk
Group A + B ESL 800 mg + CBZ 400 mg twice-daily
|
ESL 800 mg
n=23 participants at risk
Group A ESL 800 mg
|
ESL 800 mg + CBZ 200 mg
n=21 participants at risk
Group A ESL 800 mg + CBZ 200 mg
|
ESL 800 mg + CBZ 400 mg
n=19 participants at risk
Group A ESL 800 mg + CBZ 400 mg
|
Before Treatment
n=43 participants at risk
Group A and B Before treatment
|
After Treatment
n=38 participants at risk
Group A and B After treatment
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
15.8%
3/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Eye disorders
Vision blurred
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
7.7%
3/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20
|
0.00%
0/20
|
5.0%
1/20
|
5.1%
2/39
|
0.00%
0/23
|
0.00%
0/21
|
10.5%
2/19
|
0.00%
0/43
|
2.6%
1/38
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
5.1%
2/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
4.3%
1/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
4.8%
1/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20
|
5.0%
1/20
|
5.0%
1/20
|
7.7%
3/39
|
8.7%
2/23
|
0.00%
0/21
|
10.5%
2/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.1%
2/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
General disorders
Asthenia
|
15.0%
3/20
|
20.0%
4/20
|
35.0%
7/20
|
12.8%
5/39
|
30.4%
7/23
|
14.3%
3/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
General disorders
Feeling drunk
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
General disorders
Malaise
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
2.6%
1/38
|
|
General disorders
Oedema peripheral
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
General disorders
Pyrexia
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20
|
5.0%
1/20
|
10.0%
2/20
|
2.6%
1/39
|
0.00%
0/23
|
4.8%
1/21
|
5.3%
1/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Investigations
Inspiratory capacity abnormal
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20
|
0.00%
0/20
|
5.0%
1/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
2.6%
1/38
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20
|
0.00%
0/20
|
20.0%
4/20
|
20.5%
8/39
|
0.00%
0/23
|
19.0%
4/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Nervous system disorders
Dystonia
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
12.8%
5/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Nervous system disorders
Headache
|
25.0%
5/20
|
10.0%
2/20
|
15.0%
3/20
|
23.1%
9/39
|
17.4%
4/23
|
4.8%
1/21
|
10.5%
2/19
|
0.00%
0/43
|
5.3%
2/38
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20
|
0.00%
0/20
|
10.0%
2/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Nervous system disorders
Sciatica
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
2.6%
1/38
|
|
Nervous system disorders
Somnolence
|
20.0%
4/20
|
5.0%
1/20
|
25.0%
5/20
|
12.8%
5/39
|
17.4%
4/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
2.6%
1/38
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
4.8%
1/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Skin and subcutaneous tissue disorders
Sweat gland disorder
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.1%
2/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Vascular disorders
Hot flush
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.1%
2/39
|
0.00%
0/23
|
4.8%
1/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
2.6%
1/39
|
0.00%
0/23
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/43
|
0.00%
0/38
|
|
Nervous system disorders
Tremor
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/39
|
0.00%
0/23
|
0.00%
0/21
|
0.00%
0/19
|
0.00%
0/43
|
0.00%
0/38
|
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