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A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067

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: NCT01568034
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : January 12, 2015
Last Update Posted : January 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: BIA 9-1067
Drug: Placebo
Drug: Levodopa/Carbidopa
Drug: Levodopa/Benzerazide
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Sequence A Treatment Sequence B Treatment Sequence C Treatment Sequence D
Hide Arm/Group Description

Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067

Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half

Period Title: Overall Study
Started 2 2 3 3
25 mg BIA 9-1067 2 2 3 3
50 mg BIA 9-1067 2 2 3 3
100 mg BIA 9-1067 2 2 3 3
Placebo 1 2 3 3
Completed 1 2 3 3
Not Completed 1 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0
Arm/Group Title Overall Study
Hide Arm/Group Description The study was to consist of four consecutive treatment periods, corresponding to the 4 different treatment options (25 mg, 50 mg and 100 mg BIA 9-1067or Placebo).According to randomisation, subjects were to receive, in a double-blind manner, 25, 50 and 100 mg BIA 9-1067 or Placebo at 4 separate treatment periods. Each subject were to receive each of the three BIA 9-1067 doses and Placebo in a random sequence with a 3:1 ratio (BIA 9-1067: Placebo) per treatment period.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  40.0%
>=65 years
6
  60.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
1.Primary Outcome
Title Cmax - Maximum Plasma Concentration Day 3
Hide Description Cmax - Maximum plasma concentration (ng/mL)
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo BIA 9-1067 25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg
Hide Arm/Group Description:
PLC, Placebo
BIA 9-1067 - OPC, Opicapone
BIA 9-1067 - OPC, Opicapone
BIA 9-1067 - OPC, Opicapone
Overall Number of Participants Analyzed 9 10 10 10
Mean (Standard Deviation)
Unit of Measure: ng/ml
Cmax (levodopa) 2103  (48.4) 2112  (49.6) 2366  (44.0) 2657  (32.5)
Cmax (3-OMD) 3996  (50.5) 4193  (42.4) 4284  (49.2) 4085  (60.4)
Cmax (BIA 9-067) NA [1]   (NA) 320  (57.2) 590  (41.5) 816  (35.5)
[1]
BIA 9-067 was not administered
2.Primary Outcome
Title Tmax = Time to Cmax Day 3
Hide Description tmax = time to Cmax (values are median)
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo BIA 9-1067 25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg
Hide Arm/Group Description:
PLC, Placebo
BIA 9-1067 - OPC, Opicapone
BIA 9-1067 - OPC, Opicapone
BIA 9-1067 - OPC, Opicapone
Overall Number of Participants Analyzed 9 10 10 10
Median (Full Range)
Unit of Measure: hours
Tmax (levodopa)
0.5
(0.5 to 1.5)
1.0
(0.5 to 2.0)
0.5
(0.5 to 2.0)
0.5
(0.5 to 1.5)
Tmax (3-OMD)
2.00
(0.0 to 3.0)
1.75
(0.0 to 4.0)
2.50
(0.0 to 4.0)
1.75
(1.0 to 6.0)
Tmax (BIA 9-067)
NA [1] 
(NA to NA)
2.00
(0.5 to 3.0)
2.00
(1.0 to 6.0)
2.00
(1.0 to 4.0)
[1]
BIA 9-067 was not administered
3.Secondary Outcome
Title AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)
Hide Description AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo BIA 9-1067 25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg
Hide Arm/Group Description:
PLC, Placebo
BIA 9-1067 - OPC, Opicapone
BIA 9-1067 - OPC, Opicapone
BIA 9-1067 - OPC, Opicapone
Overall Number of Participants Analyzed 9 10 10 10
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
AUC0-6 (levodopa) 3958  (46.7) 4545  (61.4) 4580  (36.5) 5440  (46.4)
AUC0-6 (3-OMD) 22334  (51.1) 22026  (44.3) 23515  (50.0) 22200  (61.4)
AUC0-6 (BIA 9-1067) NA [1]   (NA) 776  (60.1) 1694  (34.6) 2647  (51.4)
[1]
BIA 9-067 was not administered
Time Frame 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg BIA 9-1067 Placebo
Hide Arm/Group Description 25 mg BIA 9-1067 ESL, Eslicarbazepine 50 mg BIA 9-1067 ESL, Eslicarbazepine 100 mg BIA 9-1067 ESL, Eslicarbazepine Placebo ESL, Eslicarbazepine
All-Cause Mortality
25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg BIA 9-1067 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg BIA 9-1067 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
25 mg BIA 9-1067 50 mg BIA 9-1067 100 mg BIA 9-1067 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/10 (50.00%)   6/10 (60.00%)   7/10 (70.00%)   3/9 (33.33%) 
Blood and lymphatic system disorders         
ANAEMIA  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
Cardiac disorders         
TACHYCARDIA  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/9 (0.00%) 
SUPRAVENTRICULAR EXTRASYSTOLES  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Ear and labyrinth disorders         
VERTIGO  1  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  0/9 (0.00%) 
Gastrointestinal disorders         
ABDOMINAL PAIN UPPER  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
CONSTIPATION  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
General disorders         
OEDEMA PERIPHERAL  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
Infections and infestations         
INFLUENZA  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
RESPIRATORY INFECTION  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
Investigations         
EOSINOPHIL PERCENTAGE INCREASED  1  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  1/9 (11.11%) 
BLOOD PRESSURE INCREASED  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/9 (0.00%) 
Nervous system disorders         
SOMNOLENCE  1  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  1/9 (11.11%) 
HEADACHE  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
LIGHTHEADEDNESS  1  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  0/9 (0.00%) 
Psychiatric disorders         
HALLUCINATION  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
INSOMNIA  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Renal and urinary disorders         
HAEMATURIA  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders         
HYPERHIDROSIS  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
PRURITUS  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
Vascular disorders         
PALLOR  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
HYPERTENSION  1  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  0/9 (0.00%) 
HYPOTENSION  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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: +351-229866100
EMail: clinical.trials@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01568034    
Other Study ID Numbers: BIA-91067-201
2008-003869-72 ( EudraCT Number )
First Submitted: March 29, 2012
First Posted: April 2, 2012
Results First Submitted: February 5, 2014
Results First Posted: January 12, 2015
Last Update Posted: January 12, 2015