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Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients. (BIPARKII)

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ClinicalTrials.gov Identifier: NCT01227655
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : January 13, 2015
Last Update Posted : October 19, 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: BIA 9-1067
Drug: Placebo
Drug: Levodopa
Drug: Carbidopa
Drug: Benserazide
Enrollment 427
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo
Hide Arm/Group Description BIA 9-1067 once daily (QD). BIA 9-1067 once daily (QD). Placebo: comparator
Period Title: Overall Study
Started 129 154 144
Safety Set 125 150 136
Full Analysis Set 125 147 135
Completed 118 128 130
Not Completed 11 26 14
Arm/Group Title BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo Total
Hide Arm/Group Description BIA 9-1067 once daily (QD). BIA 9-1067 once daily (QD). Placebo: comparator Total of all reporting groups
Overall Number of Baseline Participants 125 147 135 407
Hide Baseline Analysis Population Description
Four subjects from safety set who had no post-baseline OFF-time efficacy assessment were excluded from the full analysis set: three (1.9%) subjects in the OPC 50 mg group and one (0.7%) subject in the placebo group.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 147 participants 135 participants 407 participants
<70 years 96 96 107 299
≥70 years 29 51 28 108
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 147 participants 135 participants 407 participants
Female
82
  65.6%
89
  60.5%
71
  52.6%
242
  59.5%
Male
43
  34.4%
58
  39.5%
64
  47.4%
165
  40.5%
1.Primary Outcome
Title Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)
Hide Description Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI (DOPA decarboxylase inhibitor), in patients with PD and end-of-dose motor fluctuations. The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.
Time Frame 14-15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo
Hide Arm/Group Description:
BIA 9-1067 once daily (QD).
BIA 9-1067 once daily (QD).
Placebo: comparator
Overall Number of Participants Analyzed 125 147 135
Mean (Standard Deviation)
Unit of Measure: minutes
-102.8  (159.42) -124.0  (178.23) -64.5  (155.35)
2.Secondary Outcome
Title UPDRS (Unified Parkinson’s Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON)
Hide Description

Total UPDRS SCORE (I, II (ON), and III) Change from Baseline to Endpoint

  • UPDRS I evaluation of mentation, behavior, and mood
  • UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food
  • UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.

Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe

The final cumulative score will range from 0 (no disability) to 199 (total disability).

Time Frame 14-15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo
Hide Arm/Group Description:
BIA 9-1067 once daily (QD).
BIA 9-1067 once daily (QD).
Placebo: comparator
Overall Number of Participants Analyzed 125 147 135
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 30.8  (16.88) 31.7  (17.55) 31.5  (17.00)
Endpoint 26.6  (16.40) 28.7  (18.11) 28.1  (16.78)
3.Secondary Outcome
Title Parkinson’s Disease Sleep Scale (PDSS)
Hide Description

The Parkinson’s disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.

Subscale has 0-10 ratings, where 0 = severe and 10 = normal

The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability.

Time Frame 14-15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo
Hide Arm/Group Description:
BIA 9-1067 once daily (QD).
BIA 9-1067 once daily (QD).
Placebo: comparator
Overall Number of Participants Analyzed 123 147 135
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 95.75  (28.026) 102.62  (25.116) 101.76  (26.729)
Visit 5 97.99  (26.196) 103.05  (26.437) 107.11  (26.987)
Visit 7 98.79  (25.280) 103.25  (26.752) 105.39  (28.643)
4.Secondary Outcome
Title Non-motor Symptoms Scale (NMSS)
Hide Description

The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3

Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4

The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.

The NMSS total score is calculated by adding all domain scores (0–360), and lower scores mean less disability.

Time Frame 14-15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo
Hide Arm/Group Description:
BIA 9-1067 once daily (QD).
BIA 9-1067 once daily (QD).
Placebo: comparator
Overall Number of Participants Analyzed 125 147 135
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 38.2  (29.40) 36.7  (30.88) 38.2  (33.37)
Visit 5 33.7  (26.30) 33.2  (27.95) 33.5  (31.18)
Visit 7 35.0  (29.88) 31.5  (28.47) 31.6  (29.88)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo
Hide Arm/Group Description BIA 9-1067 once daily (QD). BIA 9-1067 once daily (QD). Placebo: comparator
All-Cause Mortality
BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/125 (3.20%)   9/150 (6.00%)   5/136 (3.68%) 
Gastrointestinal disorders       
NAUSEA  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
Hepatobiliary disorders       
CHOLECYSTITIS ACUTE  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
Infections and infestations       
PNEUMONIA  1  0/125 (0.00%)  0/150 (0.00%)  1/136 (0.74%) 
PYELONEPHRITIS ACUTE  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
Injury, poisoning and procedural complications       
FALL  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
FEMORAL NECK FRACTURE  1  0/125 (0.00%)  0/150 (0.00%)  1/136 (0.74%) 
HEAD INJURY  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
RADIUS FRACTURE  1  0/125 (0.00%)  0/150 (0.00%)  1/136 (0.74%) 
Investigations       
BIOPSY PROSTATE  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
Musculoskeletal and connective tissue disorders       
OSTEOARTHRITIS  1  1/125 (0.80%)  0/150 (0.00%)  0/136 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
BASAL CELL CARCINOMA  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
OVARIAN CANCER  1  0/125 (0.00%)  0/150 (0.00%)  1/136 (0.74%) 
Nervous system disorders       
COGNITIVE DISORDER  1  0/125 (0.00%)  0/150 (0.00%)  1/136 (0.74%) 
DYSKINESIA  1  1/125 (0.80%)  0/150 (0.00%)  0/136 (0.00%) 
Psychiatric disorders       
DELIRIUM FEBRILE  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
Renal and urinary disorders       
RENAL FAILURE  1  0/125 (0.00%)  0/150 (0.00%)  1/136 (0.74%) 
RENAL FAILURE ACUTE  1  1/125 (0.80%)  0/150 (0.00%)  0/136 (0.00%) 
URINARY RETENTION  1  1/125 (0.80%)  0/150 (0.00%)  0/136 (0.00%) 
Reproductive system and breast disorders       
CYSTOCELE  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
PLEURAL EFFUSION  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
PULMONARY EMBOLISM  1  0/125 (0.00%)  1/150 (0.67%)  0/136 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
BIA 9-1067 25 mg BIA 9-1067 50 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   87/125 (69.60%)   108/150 (72.00%)   68/136 (50.00%) 
Gastrointestinal disorders       
Constipation  1  12/125 (9.60%)  10/150 (6.67%)  2/136 (1.47%) 
Dry mouth  1  13/125 (10.40%)  6/150 (4.00%)  1/136 (0.74%) 
Nausea  1  8/125 (6.40%)  5/150 (3.33%)  8/136 (5.88%) 
Infections and infestations       
Urinary tract infection  1  3/125 (2.40%)  9/150 (6.00%)  2/136 (1.47%) 
Injury, poisoning and procedural complications       
Fall  1  7/125 (5.60%)  7/150 (4.67%)  9/136 (6.62%) 
Investigations       
Blood CPK increased  1  5/125 (4.00%)  12/150 (8.00%)  5/136 (3.68%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  6/125 (4.80%)  4/150 (2.67%)  2/136 (1.47%) 
Arthralgia  1  5/125 (4.00%)  4/150 (2.67%)  1/136 (0.74%) 
Nervous system disorders       
Dyskinesia  1  30/125 (24.00%)  36/150 (24.00%)  11/136 (8.09%) 
Parkinson’s disease  1  9/125 (7.20%)  6/150 (4.00%)  7/136 (5.15%) 
Headache  1  6/125 (4.80%)  6/150 (4.00%)  9/136 (6.62%) 
Dizziness  1  4/125 (3.20%)  6/150 (4.00%)  2/136 (1.47%) 
Somnolence  1  6/125 (4.80%)  3/150 (2.00%)  3/136 (2.21%) 
Psychiatric disorders       
Insomnia  1  10/125 (8.00%)  2/150 (1.33%)  3/136 (2.21%) 
Vascular disorders       
Hypertension  1  8/125 (6.40%)  6/150 (4.00%)  3/136 (2.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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: NCT01227655     History of Changes
Other Study ID Numbers: BIA-91067-302
2010-022366-27 ( EudraCT Number )
BIA-91067-302 ( Other Identifier: Bial - Portela & Cª., S.A. )
First Submitted: October 22, 2010
First Posted: October 25, 2010
Results First Submitted: November 26, 2014
Results First Posted: January 13, 2015
Last Update Posted: October 19, 2015