Trial Outcomes & Findings for Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067 (NCT NCT02071810)
NCT ID: NCT02071810
Last Updated: 2015-12-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Results posted on
2015-12-24
Participant Flow
Participant milestones
| Measure |
BIA 9-1067 5 mg
BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067
|
BIA 9-1067 10 mg
BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067
|
BIA 9-1067 20 mg
BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067
|
BIA 9-1067 30 mg
BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067
|
Placebo
Placebo, PLC
Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
7
|
9
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067
Baseline characteristics by cohort
| Measure |
BIA 9-1067 5 mg
n=6 Participants
BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067
|
BIA 9-1067 10 mg
n=6 Participants
BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067
|
BIA 9-1067 20 mg
n=6 Participants
BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067
|
BIA 9-1067 30 mg
n=7 Participants
BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067
|
Placebo
n=9 Participants
Placebo, PLC
Placebo
|
Total
n=34 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
34 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
|
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
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: participants will be followed for the duration of hospital stay, an expected average of 6 weeksOutcome measures
| Measure |
BIA 9-1067 5 mg
n=6 Participants
BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067
|
BIA 9-1067 10 mg
n=6 Participants
BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067
|
BIA 9-1067 20 mg
n=6 Participants
BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067
|
BIA 9-1067 30 mg
n=7 Participants
BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067
|
Placebo
n=9 Participants
Placebo, PLC
Placebo
|
|---|---|---|---|---|---|
|
Number of Patients With at Least One Adverse Event
|
3 Number of patients
|
1 Number of patients
|
1 Number of patients
|
2 Number of patients
|
1 Number of patients
|
Adverse Events
BIA 9-1067 5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BIA 9-1067 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BIA 9-1067 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BIA 9-1067 30 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIA 9-1067 5 mg
n=6 participants at risk
BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067
|
BIA 9-1067 10 mg
n=6 participants at risk
BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067
|
BIA 9-1067 20 mg
n=6 participants at risk
BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067
|
BIA 9-1067 30 mg
n=7 participants at risk
BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067
|
Placebo
n=9 participants at risk
Placebo, PLC
Placebo
|
|---|---|---|---|---|---|
|
Nervous system disorders
Left hemiparesia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
11.1%
1/9
|
Other adverse events
| Measure |
BIA 9-1067 5 mg
n=6 participants at risk
BIA 9-1067 (OPC, Opicapone) 5 mg
BIA 9-1067
|
BIA 9-1067 10 mg
n=6 participants at risk
BIA 9-1067 (OPC, Opicapone) 10 mg
BIA 9-1067
|
BIA 9-1067 20 mg
n=6 participants at risk
BIA 9-1067 (OPC, Opicapone) 20 mg
BIA 9-1067
|
BIA 9-1067 30 mg
n=7 participants at risk
BIA 9-1067 (OPC, Opicapone) 30 mg
BIA 9-1067
|
Placebo
n=9 participants at risk
Placebo, PLC
Placebo
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
50.0%
3/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/9
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/9
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/9
|
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