Trial Outcomes & Findings for Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients (NCT NCT01568047)
NCT ID: NCT01568047
Last Updated: 2015-12-24
Results Overview
Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses. Test Period - After the baseline period during the 21 to 28 days
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
28 days
Results posted on
2015-12-24
Participant Flow
Participant milestones
| Measure |
Placebo
PLC, Placebo
|
BIA 9-1067 (5 mg)
OPC, Opicapone
|
BIA 9-1067 (15 mg)
OPC, Opicapone
|
BIA 9-1067 (30 mg)
OPC, Opicapone
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
PLC, Placebo
|
BIA 9-1067 (5 mg)
OPC, Opicapone
|
BIA 9-1067 (15 mg)
OPC, Opicapone
|
BIA 9-1067 (30 mg)
OPC, Opicapone
|
|---|---|---|---|---|
|
Overall Study
Ineligibility
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
PLC, Placebo
|
BIA 9-1067 (5 mg)
n=10 Participants
5 mg BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 (15 mg)
n=10 Participants
15 mg BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 (30 mg)
n=10 Participants
30 mg BIA 9-1067 - OPC, Opicapone
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
≤ 49 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
|
|
Age, Customized
Between 49 and 88 years
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
40 participants
n=21 Participants
|
|
Age, Customized
≥ 88 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
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 daysBaseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses. Test Period - After the baseline period during the 21 to 28 days
Outcome measures
| Measure |
Placebo
n=9 Participants
PLC, Placebo
|
BIA 9-1067 5 mg
n=9 Participants
5 mg BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 15 mg
n=9 Participants
15 mg BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 30 mg
n=9 Participants
30 mg BIA 9-1067 - OPC, Opicapone
|
|---|---|---|---|---|
|
Cmax - Observed Maximum Concentration
Cmax (levodopa) Baseline
|
1484 ng/mL
Standard Deviation 26.0
|
1446 ng/mL
Standard Deviation 37.6
|
1753 ng/mL
Standard Deviation 43.4
|
1832 ng/mL
Standard Deviation 49.1
|
|
Cmax - Observed Maximum Concentration
Cmax (levodopa) Test
|
1203 ng/mL
Standard Deviation 29.4
|
1868 ng/mL
Standard Deviation 31.8
|
1806 ng/mL
Standard Deviation 28.4
|
2584 ng/mL
Standard Deviation 33.7
|
|
Cmax - Observed Maximum Concentration
Cmax (3-OMD) Baseline
|
4701 ng/mL
Standard Deviation 46.7
|
4631 ng/mL
Standard Deviation 31.6
|
3529 ng/mL
Standard Deviation 50.7
|
6222 ng/mL
Standard Deviation 63.6
|
|
Cmax - Observed Maximum Concentration
Cmax (3-OMD) Test
|
3770 ng/mL
Standard Deviation 45.0
|
2633 ng/mL
Standard Deviation 21.2
|
1197 ng/mL
Standard Deviation 71.8
|
1603 ng/mL
Standard Deviation 36.2
|
|
Cmax - Observed Maximum Concentration
Cmax (BIA 9-067) Test
|
NA ng/mL
Standard Deviation NA
BIA 9-067 was not administered
|
240 ng/mL
Standard Deviation 186
|
233 ng/mL
Standard Deviation 71.8
|
480 ng/mL
Standard Deviation 64.4
|
PRIMARY outcome
Timeframe: 28 daysBaseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses. Test Period - After the baseline period during the 21 to 28 days
Outcome measures
| Measure |
Placebo
n=9 Participants
PLC, Placebo
|
BIA 9-1067 5 mg
n=9 Participants
5 mg BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 15 mg
n=9 Participants
15 mg BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 30 mg
n=9 Participants
30 mg BIA 9-1067 - OPC, Opicapone
|
|---|---|---|---|---|
|
Tmax - Time to Observed Maximum Concentration
Cmax (levodopa) Baseline
|
1.0 ng/mL
Interval 0.5 to 4.0
|
1.0 ng/mL
Interval 0.5 to 4.0
|
0.5 ng/mL
Interval 0.5 to 1.0
|
1.0 ng/mL
Interval 0.5 to 2.0
|
|
Tmax - Time to Observed Maximum Concentration
Cmax (levodopa) Test
|
1.0 ng/mL
Interval 0.5 to 2.0
|
1.0 ng/mL
Interval 0.5 to 2.0
|
0.75 ng/mL
Interval 0.5 to 2.0
|
0.5 ng/mL
Interval 0.5 to 3.0
|
|
Tmax - Time to Observed Maximum Concentration
Cmax (3-OMD) Baseline
|
2.0 ng/mL
Interval 0.0 to 4.0
|
3.0 ng/mL
Interval 1.0 to 6.0
|
2.25 ng/mL
Interval 0.0 to 3.0
|
3.0 ng/mL
Interval 0.0 to 6.0
|
|
Tmax - Time to Observed Maximum Concentration
Cmax (3-OMD) Test
|
2.0 ng/mL
Interval 0.0 to 6.0
|
1.5 ng/mL
Interval 0.0 to 3.0
|
3.0 ng/mL
Interval 2.0 to 4.0
|
3.0 ng/mL
Interval 1.0 to 4.0
|
|
Tmax - Time to Observed Maximum Concentration
Cmax (BIA 9-067) Test
|
NA ng/mL
BIA 9-067 was not administered
|
2.0 ng/mL
Interval 1.0 to 4.0
|
2.0 ng/mL
Interval 1.0 to 4.0
|
2.0 ng/mL
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: 28 daysBaseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses. Test Period - After the baseline period during the 21 to 28 days
Outcome measures
| Measure |
Placebo
n=9 Participants
PLC, Placebo
|
BIA 9-1067 5 mg
n=9 Participants
5 mg BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 15 mg
n=9 Participants
15 mg BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 30 mg
n=9 Participants
30 mg BIA 9-1067 - OPC, Opicapone
|
|---|---|---|---|---|
|
AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])
AUC0-6 (levodopa) Baseline
|
2841 ng.h/mL
Standard Deviation 30.6
|
3451 ng.h/mL
Standard Deviation 45.2
|
2734 ng.h/mL
Standard Deviation 50.4
|
3862 ng.h/mL
Standard Deviation 35.1
|
|
AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])
AUC0-6 (levodopa) Test
|
2510 ng.h/mL
Standard Deviation 27.7
|
4041 ng.h/mL
Standard Deviation 18.3
|
4044 ng.h/mL
Standard Deviation 38.7
|
6297 ng.h/mL
Standard Deviation 25.5
|
|
AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])
AUC0-6 (3-OMD) Baseline
|
23301 ng.h/mL
Standard Deviation 39.7
|
23934 ng.h/mL
Standard Deviation 28.3
|
18748 ng.h/mL
Standard Deviation 58.8
|
34177 ng.h/mL
Standard Deviation 61.9
|
|
AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])
AUC0-6 (3-OMD) Test
|
21228 ng.h/mL
Standard Deviation 45.4
|
14883 ng.h/mL
Standard Deviation 22.2
|
6685 ng.h/mL
Standard Deviation 73.1
|
9059 ng.h/mL
Standard Deviation 36.5
|
|
AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])
AUC0-6 (BIA 9-067) Test
|
NA ng.h/mL
Standard Deviation NA
BIA 9-067 was not administered
|
627 ng.h/mL
Standard Deviation 202
|
698 ng.h/mL
Standard Deviation 73.1
|
1188 ng.h/mL
Standard Deviation 54.8
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BIA 9-1067 (5 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BIA 9-1067 (15 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: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Placebo, PLC
|
BIA 9-1067 (5 mg)
n=10 participants at risk
5 mg BIA 9-1067, OPC, Opicapone
|
BIA 9-1067 (15 mg)
n=10 participants at risk
15 mg BIA 9-1067, OPC, Opicapone
|
BIA 9-1067 (30 mg)
n=10 participants at risk
30 mg BIA 9-1067, OPC, Opicapone
|
|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
10.0%
1/10 • 16 months
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
|
General disorders
DRUG EFFECT DECREASED
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
General disorders
FATIGUE
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Investigations
BLOOD CREATINE
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Investigations
PHOSPHOKINASE INCREASED BLOOD LACTATE
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Investigations
DEHYDROGENASE INCREASED BLOOD PRESSURE INCREASED
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Nervous system disorders
DIZZINESS
|
10.0%
1/10 • 16 months
|
10.0%
1/10 • 16 months
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Nervous system disorders
DYSKINESIA
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
|
Nervous system disorders
PARKINSON'S DISEASE
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Nervous system disorders
TREMOR
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Psychiatric disorders
BRADYPHRENIA
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Psychiatric disorders
INSOMNIA
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
10.0%
1/10 • 16 months
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
|
Vascular disorders
HYPERTENSION
|
10.0%
1/10 • 16 months
|
10.0%
1/10 • 16 months
|
0.00%
0/10 • 16 months
|
0.00%
0/10 • 16 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER