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Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01520987
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Drug: BIA 9-1067
Drug: Placebo
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Caucasian Placebo Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC Japanese Placebo
Hide Arm/Group Description OPC, opicapone, BIA 9-1067 (once-daily). OPC, opicapone, BIA 9-1067 (once-daily). OPC, opicapone, BIA 9-1067 (once-daily).

Placebo, PLC

Placebo: once-daily

OPC, opicapone, BIA 9-1067 (once-daily). OPC, opicapone, BIA 9-1067 (once-daily). OPC, opicapone, BIA 9-1067 (once-daily).

Placebo, PLC

Placebo: once-daily

Period Title: Overall Study
Started 13 12 11 15 14 14 12 14
Dosed 13 12 11 15 14 14 12 14
Completed 12 12 11 15 14 13 12 14
Not Completed 1 0 0 0 0 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0             1             0             0
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Caucasian Placebo Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC Japanese Placebo Total
Hide Arm/Group Description

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Placebo, PLC

Placebo: once-daily

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Placebo, PLC

Placebo: once-daily

Total of all reporting groups
Overall Number of Baseline Participants 13 12 11 15 14 14 12 14 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 11 participants 15 participants 14 participants 14 participants 12 participants 14 participants 105 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
12
 100.0%
11
 100.0%
15
 100.0%
14
 100.0%
14
 100.0%
12
 100.0%
14
 100.0%
105
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 11 participants 15 participants 14 participants 14 participants 12 participants 14 participants 105 participants
Female
7
  53.8%
7
  58.3%
6
  54.5%
9
  60.0%
7
  50.0%
10
  71.4%
6
  50.0%
8
  57.1%
60
  57.1%
Male
6
  46.2%
5
  41.7%
5
  45.5%
6
  40.0%
7
  50.0%
4
  28.6%
6
  50.0%
6
  42.9%
45
  42.9%
1.Primary Outcome
Title Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
Hide Description Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC
Hide Arm/Group Description:

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Overall Number of Participants Analyzed 13 11 11 14 14 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
182  (64.5) 794  (392) 1540  (493) 176  (93.6) 797  (323) 1736  (381)
2.Primary Outcome
Title Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
Hide Description

Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.

Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose

Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC
Hide Arm/Group Description:

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Overall Number of Participants Analyzed 13 12 11 14 13 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
226  (110) 774  (361) 1550  (655) 276  (130) 959  (273) 1785  (431)
3.Primary Outcome
Title AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1)
Hide Description

AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.

Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC
Hide Arm/Group Description:

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Overall Number of Participants Analyzed 13 11 11 14 14 12
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
267  (113) 2013  (800) 3727  (1726) 319  (154) 1886  (692) 4438  (1151)
4.Primary Outcome
Title AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10)
Hide Description

AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.

Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose

Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC
Hide Arm/Group Description:

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Overall Number of Participants Analyzed 13 12 11 14 13 12
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
349  (169) 2024  (820) 3999  (1770) 441  (139) 2222  (407) 4464  (932)
5.Primary Outcome
Title AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)
Hide Description AUC0-∞ - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC
Hide Arm/Group Description:

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Overall Number of Participants Analyzed 10 11 11 11 13 12
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
338  (48.6) 2039  (798) 3756  (1734) 357  (163) 1976  (673) 4470  (1147)
6.Primary Outcome
Title AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)
Hide Description

AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.

Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose

Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC
Hide Arm/Group Description:

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Overall Number of Participants Analyzed 13 12 11 14 13 12
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
409  (147) 2056  (817) 4028  (1786) 465  (145) 2240  (406) 4510  (938)
7.Primary Outcome
Title Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
Hide Description

Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.

Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose

Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC
Hide Arm/Group Description:

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Overall Number of Participants Analyzed 13 11 11 14 14 12
Median (Full Range)
Unit of Measure: hours
2.0
(0.75 to 5.0)
2.0
(1.5 to 4.0)
3.0
(1.5 to 3.0)
2.0
(1.0 to 5.0)
2.0
(1.0 to 8.0)
2.0
(0.75 to 5.0)
8.Primary Outcome
Title Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
Hide Description

Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.

Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose

Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC
Hide Arm/Group Description:

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Overall Number of Participants Analyzed 13 12 11 14 13 12
Median (Full Range)
Unit of Measure: hours
1.00
(0.50 to 5.00)
2.00
(1.00 to 4.00)
1.50
(0.50 to 3.00)
2.00
(0.75 to 5.00)
2.00
(0.50 to 4.00)
2.00
(1.00 to 4.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Caucasian Placebo Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC Japanese Placebo
Hide Arm/Group Description

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Placebo, PLC

Placebo: once-daily

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

OPC, opicapone, BIA 9-1067

BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

Placebo, PLC

Placebo: once-daily

All-Cause Mortality
Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Caucasian Placebo Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC Japanese Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Caucasian Placebo Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC Japanese Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%)   0/11 (0.00%)   0/15 (0.00%)   0/14 (0.00%)   0/14 (0.00%)   0/12 (0.00%)   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Caucasian 5 mg OPC Caucasian 25 mg OPC Caucasian 50 mg OPC Caucasian Placebo Japanese 5 mg OPC Japanese 25 mg OPC Japanese 50 mg OPC Japanese Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/13 (53.85%)   5/12 (41.67%)   6/11 (54.55%)   8/15 (53.33%)   3/14 (21.43%)   6/14 (42.86%)   6/12 (50.00%)   5/14 (35.71%) 
Cardiac disorders                 
Palpitations  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%) 
Ear and labyrinth disorders                 
Tinnitus  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%) 
Eye disorders                 
Eyelid irritation  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/15 (6.67%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Visual impairment  1  1/13 (7.69%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Eye irritation  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%) 
Gastrointestinal disorders                 
Nausea  1  3/13 (23.08%)  0/12 (0.00%)  0/11 (0.00%)  1/15 (6.67%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%) 
Dyspepsia  1  1/13 (7.69%)  0/12 (0.00%)  1/11 (9.09%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
General disorders                 
Vessel puncture site haematoma  1  4/13 (30.77%)  3/12 (25.00%)  0/11 (0.00%)  2/15 (13.33%)  1/14 (7.14%)  2/14 (14.29%)  3/12 (25.00%)  2/14 (14.29%) 
Vessel puncture site pain  1  1/13 (7.69%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/12 (8.33%)  0/14 (0.00%) 
Fatigue  1  1/13 (7.69%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Irritability  1  0/13 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Energy increased  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%) 
Tenderness  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%) 
Infections and infestations                 
Hordeolum  1  0/13 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/15 (6.67%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Upper respiratory tract infection  1  0/13 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Upper respiratory tract infection  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  1/14 (7.14%)  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%) 
Viral infection  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%) 
Injury, poisoning and procedural complications                 
Arthropod bite  1  0/13 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/15 (6.67%)  1/14 (7.14%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Joint injury  1  0/13 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Sunburn  1  1/13 (7.69%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Contusion  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Excoriation  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%) 
Injury  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Laceratioin  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders                 
Back pain  1  0/13 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%) 
Limb discomfort  1  1/13 (7.69%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Musculoskeletal pain  1  0/13 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Musculoskeletal stifness  1  1/13 (7.69%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Myalgia  1  0/13 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Nervous system disorders                 
Dizziness  1  1/13 (7.69%)  0/12 (0.00%)  1/11 (9.09%)  1/15 (6.67%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%) 
Headache  1  0/13 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/15 (6.67%)  2/14 (14.29%)  1/14 (7.14%)  1/12 (8.33%)  2/14 (14.29%) 
Dizziness postural  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%) 
Somnolence  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%) 
Tension headache  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  2/12 (16.67%)  0/14 (0.00%) 
Presyncope  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%) 
Syncope  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/14 (0.00%) 
Renal and urinary disorders                 
Pollakiuria  1  0/13 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/14 (7.14%) 
Skin and subcutaneous tissue disorders                 
Nail discolouration  1  1/13 (7.69%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Pruritus  1  0/13 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Skin irritation  1  0/13 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/14 (0.00%) 
Vascular disorders                 
Hot flush  1  1/13 (7.69%)  0/12 (0.00%)  0/11 (0.00%)  0/15 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Research
Organization: Bial – Portela & Cª, S.A.
Phone: +351 229 866 100
EMail: jose.rocha@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01520987    
Other Study ID Numbers: BIA-91067-126
First Submitted: January 26, 2012
First Posted: January 30, 2012
Results First Submitted: July 22, 2015
Results First Posted: June 20, 2016
Last Update Posted: June 20, 2016