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Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation

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: NCT02305329
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: BIA 9-1067
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 BIA 9-1067 25 mg Group 2 BIA 9-1067 25 mg Group 1 BIA 9-1067 50 mg Group 2 BIA 9-1067 50 mg
Hide Arm/Group Description

Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC

BIA 9-1067

Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC

BIA 9-1067

Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC

BIA 9-1067

Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC

BIA 9-1067

Period Title: Overall Study
Started 14 14 14 14
Period 1 14 14 14 14
Period 2 14 13 14 14
Completed 14 13 14 14
Not Completed 0 1 0 0
Arm/Group Title Group 1 BIA 9-1067 25 mg Group 2 BIA 9-1067 25 mg Group 1 BIA 9-1067 50 mg Group 2 BIA 9-1067 50 mg Total
Hide Arm/Group Description

Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC

BIA 9-1067

Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC

BIA 9-1067

Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC

BIA 9-1067

Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC

BIA 9-1067

Total of all reporting groups
Overall Number of Baseline Participants 14 14 14 14 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 14 participants 56 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
14
 100.0%
14
 100.0%
56
 100.0%
>=65 years
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 14 participants 14 participants 14 participants 14 participants 56 participants
Female
7
  50.0%
7
  50.0%
7
  50.0%
7
  50.0%
28
  50.0%
Male
7
  50.0%
7
  50.0%
7
  50.0%
7
  50.0%
28
  50.0%
1.Primary Outcome
Title Cmax - Maximum Observed Plasma Concentration of 9-1067
Hide Description Cmax - maximum observed plasma concentration of 9-1067.
Time Frame before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5x5mg BIA 9-1067 1x25 mg BIA 9-1067 2x25 mg BIA 9-1067 1x50 mg BIA 9-1067
Hide Arm/Group Description:
5x5mg BIA 9-1067, OPC
1x25 mg BIA 9-1067, OPC
2x25 mg BIA 9-1067, OPC
1x50 mg BIA 9-1067, OPC
Overall Number of Participants Analyzed 27 28 28 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
600  (221) 567  (222) 955  (297) 917  (426)
2.Secondary Outcome
Title Tmax - Time of Occurrence of Cmax of 9-1067
Hide Description tmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067
Time Frame before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5x5mg BIA 9-1067 1x25 mg BIA 9-1067 2x25 mg BIA 9-1067 1x50 mg BIA 9-1067
Hide Arm/Group Description:
5x5mg BIA 9-1067, OPC
1x25 mg BIA 9-1067, OPC
2x25 mg BIA 9-1067, OPC
1x50 mg BIA 9-1067, OPC
Overall Number of Participants Analyzed 27 28 28 28
Median (Full Range)
Unit of Measure: hours
2.00
(1.00 to 4.00)
2.00
(1.00 to 4.00)
2.00
(1.00 to 4.00)
2.00
(0.50 to 8.00)
3.Secondary Outcome
Title AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t
Hide Description [Not Specified]
Time Frame before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5x5mg BIA 9-1067 1x25 mg BIA 9-1067 2x25 mg BIA 9-1067 1x50 mg BIA 9-1067
Hide Arm/Group Description:
5x5mg BIA 9-1067, OPC
1x25 mg BIA 9-1067, OPC
2x25 mg BIA 9-1067, OPC
1x50 mg BIA 9-1067, OPC
Overall Number of Participants Analyzed 27 28 28 28
Mean (Standard Deviation)
Unit of Measure: h.ng/mL
1603  (566) 1461  (529) 2669  (945) 2539  (1066)
4.Secondary Outcome
Title AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
Hide Description AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity.
Time Frame before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5x5mg BIA 9-1067 1x25 mg BIA 9-1067 2x25 mg BIA 9-1067 1x50 mg BIA 9-1067
Hide Arm/Group Description:
5x5mg BIA 9-1067, OPC
1x25 mg BIA 9-1067, OPC
2x25 mg BIA 9-1067, OPC
1x50 mg BIA 9-1067, OPC
Overall Number of Participants Analyzed 27 28 28 28
Mean (Standard Deviation)
Unit of Measure: h.ng/mL
1679  (586) 1539  (554) 2699  (1012) 2612  (1082)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5x5mg BIA 9-1067 1x25 mg BIA 9-1067 2x25 mg BIA 9-1067 1x50 mg BIA 9-1067
Hide Arm/Group Description 5x5mg BIA 9-1067, OPC 1x25 mg BIA 9-1067, OPC 2x25 mg BIA 9-1067, OPC 1x50 mg BIA 9-1067, OPC
All-Cause Mortality
5x5mg BIA 9-1067 1x25 mg BIA 9-1067 2x25 mg BIA 9-1067 1x50 mg BIA 9-1067
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
5x5mg BIA 9-1067 1x25 mg BIA 9-1067 2x25 mg BIA 9-1067 1x50 mg BIA 9-1067
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/28 (0.00%)   0/28 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
5x5mg BIA 9-1067 1x25 mg BIA 9-1067 2x25 mg BIA 9-1067 1x50 mg BIA 9-1067
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/27 (25.93%)   11/28 (39.29%)   12/28 (42.86%)   15/28 (53.57%) 
Gastrointestinal disorders         
Nausea  1/27 (3.70%)  2/28 (7.14%)  3/28 (10.71%)  1/28 (3.57%) 
Abdominal pain upper  0/27 (0.00%)  0/28 (0.00%)  1/28 (3.57%)  1/28 (3.57%) 
DRY MOUTH  0/27 (0.00%)  0/28 (0.00%)  1/28 (3.57%)  1/28 (3.57%) 
VOMITING  1/27 (3.70%)  0/28 (0.00%)  1/28 (3.57%)  1/28 (3.57%) 
General disorders         
Influenza like illness  2/27 (7.41%)  1/28 (3.57%)  1/28 (3.57%)  1/28 (3.57%) 
CATHETER SITE PAIN  0/27 (0.00%)  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
Immune system disorders         
Seasonal allergy  0/27 (0.00%)  0/28 (0.00%)  2/28 (7.14%)  0/28 (0.00%) 
Infections and infestations         
Nasopharyngitis  1/27 (3.70%)  1/28 (3.57%)  1/28 (3.57%)  3/28 (10.71%) 
BACTERIAL VAGINOSIS  0/27 (0.00%)  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
ORAL HERPES  0/27 (0.00%)  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
Musculoskeletal and connective tissue disorders         
BACK PAIN  0/27 (0.00%)  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
MUSCULOSKELETAL PAIN  1/27 (3.70%)  0/28 (0.00%)  0/28 (0.00%)  0/28 (0.00%) 
MUSCULOSKELETAL STIFFNESS  0/27 (0.00%)  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
MYALGIA  0/27 (0.00%)  1/28 (3.57%)  1/28 (3.57%)  0/28 (0.00%) 
Nervous system disorders         
Headache  3/27 (11.11%)  5/28 (17.86%)  6/28 (21.43%)  4/28 (14.29%) 
Somnolence  0/27 (0.00%)  2/28 (7.14%)  2/28 (7.14%)  1/28 (3.57%) 
DIZZINESS  1/27 (3.70%)  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
TENSION HEADACHE  1/27 (3.70%)  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
Reproductive system and breast disorders         
DYSMENORRHOEA  0/27 (0.00%)  0/28 (0.00%)  0/28 (0.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  0/27 (0.00%)  1/28 (3.57%)  0/28 (0.00%)  0/28 (0.00%) 
Skin and subcutaneous tissue disorders         
ECCHYMOSIS  0/27 (0.00%)  1/28 (3.57%)  0/28 (0.00%)  0/28 (0.00%) 
URTICARIA  0/27 (0.00%)  1/28 (3.57%)  0/28 (0.00%)  0/28 (0.00%) 
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: NCT02305329    
Other Study ID Numbers: BIA-91067-121
First Submitted: November 28, 2014
First Posted: December 2, 2014
Results First Submitted: July 22, 2015
Results First Posted: August 21, 2015
Last Update Posted: August 21, 2015