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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022366-27 | EudraCT Number | ||
| BIA-91067-302 | Other Identifier | Bial - Portela & Cª., S.A. |
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Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year.
BIA 9-1067 is currently being developed by BIAL (Portela & Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.
This study aims to demonstrate the efficacy and safety of BIA 9-1067 used in addition to L-DOPA/DDCI to control the "wearing-off" phenomenon in patients with PD.
DDCI (DOPA decarboxylase inhibitors): benserazide and carbidopa
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIA 9-1067 25 mg once daily (QD). | Experimental | BIA 9-1067, OPC, Opicapone 25 mg once daily (QD). |
|
| BIA 9-1067 50 mg once daily (QD). | Experimental | BIA 9-1067, OPC, Opicapone 50 mg once daily (QD). |
|
| Placebo | Placebo Comparator | PLC, Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIA 9-1067 | Drug | Capsules will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 14-15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS (Unified Parkinson's Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON) | Total UPDRS SCORE (I, II (ON), and III) Change from Baseline to Endpoint
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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bial - Portela & Cª, S.A. | S. Mamede Do Coronado | 4745-457 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28027332 | Derived | Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, Soares-da-Silva P; BIPARK-2 Study Investigators. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):197-206. doi: 10.1001/jamaneurol.2016.4703. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BIA 9-1067 25 mg | BIA 9-1067 once daily (QD). |
| FG001 | BIA 9-1067 50 mg | BIA 9-1067 once daily (QD). |
| FG002 | Placebo | Placebo: comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | BIA 9-1067 25 mg | BIA 9-1067 once daily (QD). |
| BG001 | BIA 9-1067 50 mg | BIA 9-1067 once daily (QD). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | Posted | Mean | Standard Deviation | minutes | 14-15 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIA 9-1067 25 mg | BIA 9-1067 once daily (QD). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyskinesia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research | Bial - Portela & Cª, S.A. | +351 229 866 100 | jose.rocha@bial.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C549349 | opicapone |
| D007980 | Levodopa |
| D002230 | Carbidopa |
| D001545 | Benserazide |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | comparator |
|
|
| Levodopa | Drug |
|
|
| Carbidopa | Drug | DOPA decarboxylase inhibitor (DDCI) |
|
| Benserazide | Drug | DOPA decarboxylase inhibitor |
|
| 14-15 weeks |
| Parkinson's Disease Sleep Scale (PDSS) | 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. | 14-15 weeks |
| Non-motor Symptoms Scale (NMSS) | 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. | 14-15 weeks |
| BG002 |
| Placebo |
Placebo: comparator |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Placebo | Placebo: comparator |
|
|
| Secondary | UPDRS (Unified Parkinson's Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON) | Total UPDRS SCORE (I, II (ON), and III) Change from Baseline to Endpoint
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). | Posted | Mean | Standard Deviation | units on a scale | 14-15 weeks |
|
|
|
| Secondary | Parkinson's Disease Sleep Scale (PDSS) | 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. | Posted | Mean | Standard Deviation | units on a scale | 14-15 weeks |
|
|
|
| Secondary | Non-motor Symptoms Scale (NMSS) | 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. | Posted | Mean | Standard Deviation | units on a scale | 14-15 weeks |
|
|
|
| 4 |
| 125 |
| 87 |
| 125 |
| EG001 | BIA 9-1067 50 mg | BIA 9-1067 once daily (QD). | 9 | 150 | 108 | 150 |
| EG002 | Placebo | Placebo: comparator | 5 | 136 | 68 | 136 |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| BIOPSY PROSTATE | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
|
| OVARIAN CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
|
| COGNITIVE DISORDER | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| DYSKINESIA | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| DELIRIUM FEBRILE | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| CYSTOCELE | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Blood CPK increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D008750 | Methyldopa |
| D006834 | Hydrazines |
|
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| Visit 7 |
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| Visit 7 |
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