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Trial record 14 of 18 for:    "Basal Ganglia Disease" | "Benserazide"

Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients

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: NCT01568047
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : January 8, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: Placebo
Drug: BIA 9-1067
Drug: Levodopa/Carbidopa
Drug: Levodopa/Benzerazide
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo BIA 9-1067 (5 mg) BIA 9-1067 (15 mg) BIA 9-1067 (30 mg)
Hide Arm/Group Description PLC, Placebo OPC, Opicapone OPC, Opicapone OPC, Opicapone
Period Title: Overall Study
Started 10 10 10 10
Completed 9 9 9 9
Not Completed 1 1 1 1
Reason Not Completed
Ineligibility             1             0             0             0
Withdrawal by Subject             0             1             0             0
Adverse Event             0             0             1             1
Arm/Group Title Placebo BIA 9-1067 (5 mg) BIA 9-1067 (15 mg) BIA 9-1067 (30 mg) Total
Hide Arm/Group Description PLC, Placebo 5 mg BIA 9-1067 - OPC, Opicapone 15 mg BIA 9-1067 - OPC, Opicapone 30 mg BIA 9-1067 - OPC, Opicapone Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 10 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
≤ 49 years 0 0 0 0 0
Between 49 and 88 years 10 10 10 10 40
≥ 88 years 0 0 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
Female
5
  50.0%
6
  60.0%
4
  40.0%
5
  50.0%
20
  50.0%
Male
5
  50.0%
4
  40.0%
6
  60.0%
5
  50.0%
20
  50.0%
1.Primary Outcome
Title Cmax - Observed Maximum Concentration
Hide Description

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

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo BIA 9-1067 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg
Hide Arm/Group Description:
PLC, Placebo
5 mg BIA 9-1067 - OPC, Opicapone
15 mg BIA 9-1067 - OPC, Opicapone
30 mg BIA 9-1067 - OPC, Opicapone
Overall Number of Participants Analyzed 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax (levodopa) Baseline 1484  (26.0) 1446  (37.6) 1753  (43.4) 1832  (49.1)
Cmax (levodopa) Test 1203  (29.4) 1868  (31.8) 1806  (28.4) 2584  (33.7)
Cmax (3-OMD) Baseline 4701  (46.7) 4631  (31.6) 3529  (50.7) 6222  (63.6)
Cmax (3-OMD) Test 3770  (45.0) 2633  (21.2) 1197  (71.8) 1603  (36.2)
Cmax (BIA 9-067) Test NA [1]   (NA) 240  (186) 233  (71.8) 480  (64.4)
[1]
BIA 9-067 was not administered
2.Primary Outcome
Title Tmax - Time to Observed Maximum Concentration
Hide Description

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

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo BIA 9-1067 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg
Hide Arm/Group Description:
PLC, Placebo
5 mg BIA 9-1067 - OPC, Opicapone
15 mg BIA 9-1067 - OPC, Opicapone
30 mg BIA 9-1067 - OPC, Opicapone
Overall Number of Participants Analyzed 9 9 9 9
Median (Full Range)
Unit of Measure: ng/mL
Cmax (levodopa) Baseline
1.0
(0.5 to 4.0)
1.0
(0.5 to 4.0)
0.5
(0.5 to 1.0)
1.0
(0.5 to 2.0)
Cmax (levodopa) Test
1.0
(0.5 to 2.0)
1.0
(0.5 to 2.0)
0.75
(0.5 to 2.0)
0.5
(0.5 to 3.0)
Cmax (3-OMD) Baseline
2.0
(0.0 to 4.0)
3.0
(1.0 to 6.0)
2.25
(0.0 to 3.0)
3.0
(0.0 to 6.0)
Cmax (3-OMD) Test
2.0
(0.0 to 6.0)
1.5
(0.0 to 3.0)
3.0
(2.0 to 4.0)
3.0
(1.0 to 4.0)
Cmax (BIA 9-067) Test
NA [1] 
(NA to NA)
2.0
(1.0 to 4.0)
2.0
(1.0 to 4.0)
2.0
(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 (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])
Hide Description

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

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo BIA 9-1067 5 mg BIA 9-1067 15 mg BIA 9-1067 30 mg
Hide Arm/Group Description:
PLC, Placebo
5 mg BIA 9-1067 - OPC, Opicapone
15 mg BIA 9-1067 - OPC, Opicapone
30 mg BIA 9-1067 - OPC, Opicapone
Overall Number of Participants Analyzed 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
AUC0-6 (levodopa) Baseline 2841  (30.6) 3451  (45.2) 2734  (50.4) 3862  (35.1)
AUC0-6 (levodopa) Test 2510  (27.7) 4041  (18.3) 4044  (38.7) 6297  (25.5)
AUC0-6 (3-OMD) Baseline 23301  (39.7) 23934  (28.3) 18748  (58.8) 34177  (61.9)
AUC0-6 (3-OMD) Test 21228  (45.4) 14883  (22.2) 6685  (73.1) 9059  (36.5)
AUC0-6 (BIA 9-067) Test NA [1]   (NA) 627  (202) 698  (73.1) 1188  (54.8)
[1]
BIA 9-067 was not administered
Time Frame 16 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo BIA 9-1067 (5 mg) BIA 9-1067 (15 mg) BIA 9-1067 (30 mg)
Hide Arm/Group Description Placebo, PLC 5 mg BIA 9-1067, OPC, Opicapone 15 mg BIA 9-1067, OPC, Opicapone 30 mg BIA 9-1067, OPC, Opicapone
All-Cause Mortality
Placebo BIA 9-1067 (5 mg) BIA 9-1067 (15 mg) BIA 9-1067 (30 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo BIA 9-1067 (5 mg) BIA 9-1067 (15 mg) BIA 9-1067 (30 mg)
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%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo BIA 9-1067 (5 mg) BIA 9-1067 (15 mg) BIA 9-1067 (30 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/10 (50.00%)   1/10 (10.00%)   1/10 (10.00%)   4/10 (40.00%) 
Gastrointestinal disorders         
ABDOMINAL PAIN UPPER  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
DIARRHOEA  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
NAUSEA  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%) 
TOOTHACHE  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
General disorders         
DRUG EFFECT DECREASED  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
FATIGUE  1  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%)  0/10 (0.00%) 
Investigations         
BLOOD CREATINE  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
PHOSPHOKINASE INCREASED BLOOD LACTATE  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
DEHYDROGENASE INCREASED BLOOD PRESSURE INCREASED  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Nervous system disorders         
DIZZINESS  1  1/10 (10.00%)  1/10 (10.00%)  1/10 (10.00%)  0/10 (0.00%) 
DYSKINESIA  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
PARKINSON'S DISEASE  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
TREMOR  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
Psychiatric disorders         
BRADYPHRENIA  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
DEPRESSION  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
INSOMNIA  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
DYSPNOEA  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders         
HYPERHIDROSIS  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%) 
SEBORRHOEIC DERMATITIS  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Vascular disorders         
HYPERTENSION  1  1/10 (10.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (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: NCT01568047     History of Changes
Other Study ID Numbers: BIA-91067-202
2009-012897-12 ( EudraCT Number )
First Submitted: March 29, 2012
First Posted: April 2, 2012
Results First Submitted: February 5, 2014
Results First Posted: January 8, 2015
Last Update Posted: December 24, 2015