Trial Outcomes & Findings for A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093 (NCT NCT02171195)
NCT ID: NCT02171195
Last Updated: 2016-07-20
Results Overview
An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
up to 20 weeks
Results posted on
2016-07-20
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo, PLC
|
Group 1 20 mg
BIA 2-093 20mg or placebo.
|
Group 2 50 mg
BIA 2-093 50mg or placebo
|
Group 3 100 mg
BIA 2-093 100mg or placebo
|
Group 4 200 mg
BIA 2-093 200mg or placebo
|
Group 5 400 mg
BIA 2-093 or 400mg or placebo
|
Group 6 600 mg
BIA 2-093 600mg or placebo
|
Group 7 900 mg
BIA 2-093 900mg or placebo
|
Group 8 1200 mg
BIA 2-093 1200mg or placebo
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
16
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Placebo, PLC
|
Group 1 20 mg
n=6 Participants
BIA 2-093 20mg or placebo.
|
Group 2 50 mg
n=6 Participants
BIA 2-093 50mg or placebo
|
Group 3 100 mg
n=6 Participants
BIA 2-093 100mg or placebo
|
Group 4 200 mg
n=6 Participants
BIA 2-093 200mg or placebo
|
Group 5 400 mg
n=6 Participants
BIA 2-093 or 400mg or placebo
|
Group 6 600 mg
n=6 Participants
BIA 2-093 600mg or placebo
|
Group 7 900 mg
n=6 Participants
BIA 2-093 900mg or placebo
|
Group 8 1200 mg
n=6 Participants
BIA 2-093 1200mg or placebo
|
Total
n=64 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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
64 Participants
n=42 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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
64 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: up to 20 weeksAn adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo, PLC
|
Group 1 20 mg
n=6 Participants
BIA 2-093 20mg or placebo.
|
Group 2 50 mg
n=6 Participants
BIA 2-093 50mg or placebo
|
Group 3 100 mg
n=6 Participants
BIA 2-093 100mg or placebo
|
Group 4 200 mg
n=6 Participants
BIA 2-093 200mg or placebo
|
Group 5 400 mg
n=6 Participants
BIA 2-093 or 400mg or placebo
|
Group 6 600 mg
n=6 Participants
BIA 2-093 600mg or placebo
|
Group 7 900 mg
n=6 Participants
BIA 2-093 900mg or placebo
|
Group 8 1200 mg
n=6 Participants
BIA 2-093 1200mg or placebo
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Number of Adverse Events
AE of Mild Severity
|
7 Number of Adverse Events
|
5 Number of Adverse Events
|
3 Number of Adverse Events
|
6 Number of Adverse Events
|
2 Number of Adverse Events
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
2 Number of Adverse Events
|
7 Number of Adverse Events
|
|
Total Number of Adverse Events
All Adverse Events
|
7 Number of Adverse Events
|
7 Number of Adverse Events
|
3 Number of Adverse Events
|
7 Number of Adverse Events
|
2 Number of Adverse Events
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
2 Number of Adverse Events
|
7 Number of Adverse Events
|
|
Total Number of Adverse Events
AE Considered Not Related to Treatment
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
4 Number of Adverse Events
|
|
Total Number of Adverse Events
AE Considered Possibly Related to Treatment
|
7 Number of Adverse Events
|
5 Number of Adverse Events
|
3 Number of Adverse Events
|
7 Number of Adverse Events
|
2 Number of Adverse Events
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
2 Number of Adverse Events
|
3 Number of Adverse Events
|
|
Total Number of Adverse Events
AE of Moderate Severity
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 1 20 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 3 100 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4 200 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 5 400 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 6 600 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 7 900 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 8 1200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Placebo, PLC
|
Group 1 20 mg
n=6 participants at risk
BIA 2-093 20mg or placebo.
|
Group 2 50 mg
n=6 participants at risk
BIA 2-093 50mg or placebo
|
Group 3 100 mg
n=6 participants at risk
BIA 2-093 100mg or placebo
|
Group 4 200 mg
n=6 participants at risk
BIA 2-093 200mg or placebo
|
Group 5 400 mg
n=6 participants at risk
BIA 2-093 or 400mg or placebo
|
Group 6 600 mg
n=6 participants at risk
BIA 2-093 600mg or placebo
|
Group 7 900 mg
n=6 participants at risk
BIA 2-093 900mg or placebo
|
Group 8 1200 mg
n=6 participants at risk
BIA 2-093 1200mg or placebo
|
|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/16
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Psychiatric disorders
Somnolence
|
12.5%
2/16
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Upper resp tract infection
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Eye pain
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Mouth dry
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
18.8%
3/16
|
33.3%
2/6
|
33.3%
2/6
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER