Trial Outcomes & Findings for Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic (NCT NCT01519284)
NCT ID: NCT01519284
Last Updated: 2015-08-20
Results Overview
Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
8 days
Results posted on
2015-08-20
Participant Flow
Participant milestones
| Measure |
Group 1
Placebo at all the dosing times
|
Group 2
Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 3
Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 4
Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 5
Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
18
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
16
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic
Baseline characteristics by cohort
| Measure |
Group 1
n=16 Participants
Placebo at all the dosing times
Placebo: placebo (four times a day)
|
Group 2
n=16 Participants
Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
BIA 9-1067 5 mg: BIA 9-1067 OPC, Opicapone 5 mg
Placebo: placebo (four times a day)
levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)
|
Group 3
n=18 Participants
Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
Placebo: placebo (four times a day)
levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)
BIA 9-1067 15 mg: BIA 9-1067 OPC, Opicapone 15 mg
|
Group 4
n=16 Participants
Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose
Placebo: placebo (four times a day)
levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)
BIA 9-1067 30 mg: BIA 9-1067 OPC, Opicapone 30 mg
|
Group 5
n=16 Participants
Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
Entacapone: Entacapone 200 mg
Placebo: placebo (four times a day)
levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)
|
Total
n=82 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
82 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 8 daysCmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
Outcome measures
| Measure |
Group 1
n=16 Participants
Placebo at all the dosing times
|
Group 2
n=16 Participants
Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 3
n=16 Participants
Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 4
n=16 Participants
Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 5
n=16 Participants
Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
|
|---|---|---|---|---|---|
|
Cmax - Maximum Plasma Concentration of Levodopa
|
1076 ng/mL
Standard Deviation 292.7
|
1106 ng/mL
Standard Deviation 420.3
|
943 ng/mL
Standard Deviation 325.3
|
981 ng/mL
Standard Deviation 488.5
|
928 ng/mL
Standard Deviation 245
|
SECONDARY outcome
Timeframe: 8 daysTmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.
Outcome measures
| Measure |
Group 1
n=16 Participants
Placebo at all the dosing times
|
Group 2
n=16 Participants
Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 3
n=16 Participants
Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 4
n=16 Participants
Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 5
n=16 Participants
Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
|
|---|---|---|---|---|---|
|
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa
|
0.75 hours
Interval 0.25 to 1.0
|
0.75 hours
Interval 0.25 to 1.0
|
0.75 hours
Interval 0.25 to 3.0
|
0.75 hours
Interval 0.25 to 1.0
|
0.75 hours
Interval 0.25 to 1.0
|
SECONDARY outcome
Timeframe: 8 daysAUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days
Outcome measures
| Measure |
Group 1
n=16 Participants
Placebo at all the dosing times
|
Group 2
n=16 Participants
Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 3
n=16 Participants
Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 4
n=16 Participants
Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 5
n=16 Participants
Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
|
|---|---|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.
|
1578 ng.h/mL
Standard Deviation 320.3
|
1785 ng.h/mL
Standard Deviation 574.8
|
2102 ng.h/mL
Standard Deviation 569.6
|
2202 ng.h/mL
Standard Deviation 605.6
|
2146 ng.h/mL
Standard Deviation 538.6
|
SECONDARY outcome
Timeframe: 8 daysAUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.
Outcome measures
| Measure |
Group 1
n=16 Participants
Placebo at all the dosing times
|
Group 2
n=16 Participants
Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 3
n=16 Participants
Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 4
n=16 Participants
Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 5
n=16 Participants
Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
|
|---|---|---|---|---|---|
|
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity
|
1649 ng.h/mL
Standard Deviation 313.3
|
1873 ng.h/mL
Standard Deviation 571.3
|
2233 ng.h/mL
Standard Deviation 578.3
|
2381 ng.h/mL
Standard Deviation 623.8
|
2253 ng.h/mL
Standard Deviation 540.7
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 3
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 5
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=16 participants at risk
Placebo at all the dosing times
|
Group 2
n=16 participants at risk
Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 3
n=17 participants at risk
Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 4
n=16 participants at risk
Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 5
n=16 participants at risk
Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
|
|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
spontaneous abortion
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
Other adverse events
| Measure |
Group 1
n=16 participants at risk
Placebo at all the dosing times
|
Group 2
n=16 participants at risk
Day 1 to 7:
BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 3
n=17 participants at risk
Day 1 to 7:
BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 4
n=16 participants at risk
Day 1 to 7:
BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose
Day 8:
BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose
|
Group 5
n=16 participants at risk
Day 1 to 7:
Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose
Day 8:
Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
6.2%
1/16
|
|
Eye disorders
Conjunctivitis
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Eye disorders
Edema eyelid
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
6.2%
1/16
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/17
|
6.2%
1/16
|
6.2%
1/16
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
General disorders
Application site haematoma
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
General disorders
Device breakage
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
|
General disorders
Injection site haematoma
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
6.2%
1/16
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
6.2%
1/16
|
|
Infections and infestations
Tooth infection
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
6.2%
1/16
|
|
Infections and infestations
Upper respiratory tract
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
12.5%
2/16
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
Investigations
CK increased
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
12.5%
2/16
|
0.00%
0/16
|
|
Investigations
Weight increased
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
6.2%
1/16
|
6.2%
1/16
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
6.2%
1/16
|
|
Nervous system disorders
Headache
|
12.5%
2/16
|
0.00%
0/16
|
11.8%
2/17
|
12.5%
2/16
|
6.2%
1/16
|
|
Nervous system disorders
Migraine
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
6.2%
1/16
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
18.8%
3/16
|
0.00%
0/16
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Psychiatric disorders
Acute stress disorder
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
6.2%
1/16
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
6.2%
1/16
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
1/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/17
|
6.2%
1/16
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/17
|
0.00%
0/16
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/16
|
0.00%
0/16
|
5.9%
1/17
|
0.00%
0/16
|
0.00%
0/16
|
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