Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-27 @ 6:39 AM
Study NCT ID:
NCT01568034
Status:
COMPLETED
Last Update Posted:
2015-01-12
First Post:
2012-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067
Sponsor:
Organization:
Raw JSON
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{'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@bial.com', 'phone': '+351-229866100', 'title': 'Head of Clinical Research', 'organization': 'BIAL - Portela & Cª S.A.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '10 months', 'eventGroups': [{'id': 'EG000', 'title': '25 mg BIA 9-1067', 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{'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'SUPRAVENTRICULAR EXTRASYSTOLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'HYPERHIDROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'PALLOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'RESPIRATORY INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'HALLUCINATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'BLOOD PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'LIGHTHEADEDNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax - Maximum Plasma Concentration Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'PLC, Placebo'}, {'id': 'OG001', 'title': 'BIA 9-1067 25 mg', 'description': 'BIA 9-1067 - OPC, Opicapone'}, {'id': 'OG002', 'title': 'BIA 9-1067 50 mg', 'description': 'BIA 9-1067 - OPC, Opicapone'}, {'id': 'OG003', 'title': 'BIA 9-1067 100 mg', 'description': 'BIA 9-1067 - OPC, Opicapone'}], 'classes': [{'title': 'Cmax (levodopa)', 'categories': [{'measurements': [{'value': '2103', 'spread': '48.4', 'groupId': 'OG000'}, {'value': '2112', 'spread': '49.6', 'groupId': 'OG001'}, {'value': '2366', 'spread': '44.0', 'groupId': 'OG002'}, {'value': '2657', 'spread': '32.5', 'groupId': 'OG003'}]}]}, {'title': 'Cmax (3-OMD)', 'categories': [{'measurements': [{'value': '3996', 'spread': '50.5', 'groupId': 'OG000'}, {'value': '4193', 'spread': '42.4', 'groupId': 'OG001'}, {'value': '4284', 'spread': '49.2', 'groupId': 'OG002'}, {'value': '4085', 'spread': '60.4', 'groupId': 'OG003'}]}]}, {'title': 'Cmax (BIA 9-067)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'BIA 9-067 was not administered', 'groupId': 'OG000'}, {'value': '320', 'spread': '57.2', 'groupId': 'OG001'}, {'value': '590', 'spread': '41.5', 'groupId': 'OG002'}, {'value': '816', 'spread': '35.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'Cmax - Maximum plasma concentration (ng/mL)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'PLC, Placebo'}, {'id': 'OG001', 'title': 'BIA 9-1067 25 mg', 'description': 'BIA 9-1067 - OPC, Opicapone'}, {'id': 'OG002', 'title': 'BIA 9-1067 50 mg', 'description': 'BIA 9-1067 - OPC, Opicapone'}, {'id': 'OG003', 'title': 'BIA 9-1067 100 mg', 'description': 'BIA 9-1067 - OPC, Opicapone'}], 'classes': [{'title': 'AUC0-6 (levodopa)', 'categories': [{'measurements': [{'value': '3958', 'spread': '46.7', 'groupId': 'OG000'}, {'value': '4545', 'spread': '61.4', 'groupId': 'OG001'}, {'value': '4580', 'spread': '36.5', 'groupId': 'OG002'}, {'value': '5440', 'spread': '46.4', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-6 (3-OMD)', 'categories': [{'measurements': [{'value': '22334', 'spread': '51.1', 'groupId': 'OG000'}, {'value': '22026', 'spread': '44.3', 'groupId': 'OG001'}, {'value': '23515', 'spread': '50.0', 'groupId': 'OG002'}, {'value': '22200', 'spread': '61.4', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-6 (BIA 9-1067)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'BIA 9-067 was not administered', 'groupId': 'OG000'}, {'value': '776', 'spread': '60.1', 'groupId': 'OG001'}, {'value': '1694', 'spread': '34.6', 'groupId': 'OG002'}, {'value': '2647', 'spread': '51.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tmax = Time to Cmax Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'PLC, Placebo'}, {'id': 'OG001', 'title': 'BIA 9-1067 25 mg', 'description': 'BIA 9-1067 - OPC, Opicapone'}, {'id': 'OG002', 'title': 'BIA 9-1067 50 mg', 'description': 'BIA 9-1067 - OPC, Opicapone'}, {'id': 'OG003', 'title': 'BIA 9-1067 100 mg', 'description': 'BIA 9-1067 - OPC, Opicapone'}], 'classes': [{'title': 'Tmax (levodopa)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.5'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.0'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '2.0'}, {'value': '0.5', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '1.5'}]}]}, {'title': 'Tmax (3-OMD)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '1.75', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '2.50', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '1.75', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '6.0'}]}]}, {'title': 'Tmax (BIA 9-067)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'BIA 9-067 was not administered', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 3', 'description': 'tmax = time to Cmax (values are median)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence A', '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\n\nLevodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half'}, {'id': 'FG001', 'title': 'Treatment Sequence B', 'description': '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\n\nLevodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half'}, {'id': 'FG002', 'title': 'Treatment Sequence C', 'description': '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\n\nLevodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half'}, {'id': 'FG003', 'title': 'Treatment Sequence D', 'description': '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\n\nLevodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': '25 mg BIA 9-1067', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': '50 mg BIA 9-1067', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': '100 mg BIA 9-1067', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', '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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-19', 'studyFirstSubmitDate': '2012-03-29', 'resultsFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-19', 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Plasma Concentration Day 3', 'timeFrame': 'Day 3', 'description': 'Cmax - Maximum plasma concentration (ng/mL)'}, {'measure': 'Tmax = Time to Cmax Day 3', 'timeFrame': 'Day 3', 'description': 'tmax = time to Cmax (values are median)'}], 'secondaryOutcomes': [{'measure': 'AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)', 'timeFrame': 'Day 3', 'description': 'AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'BIA 9-1067'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.", 'detailedDescription': 'This was a three-centre, double-blind, randomised, placebo-controlled, crossover study with four consecutive single-dose treatment periods in PD patients treated with immediate release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of non-childbearing potential (by reason of surgery or postmenopausal);\n* Aged between 30 and 75 years, inclusive;\n* A diagnosis of PD according to the UK PDS Brain Bank diagnostic criteria (bradykinesia and at least one of the following: muscular rigidity, rest tremor and postural instability);\n* Predictable signs of end-of-dose deterioration despite "optimal" levodopa/carbidopa or levodopa/benserazide therapy;\n* Been treated with a stable regimen of 3 to 8 doses of standard release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide per day within at least 1 week prior to randomisation;\n* Modified Hoehn and Yahr stage of less than 5 in the off-state;\n* Mean duration of OFF stage ≥ 1.5 h during waking hours (based on historical information);\n* Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses for at least 4 weeks prior to randomisation;\n* Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of the subject or for the purpose of the study);\n* Able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);\n* Treated with levodopa/carbidopa or levodopa/benserazide in a 10:1 ratio, or with levodopa/carbidopa in a controlled-release formulation;\n* Treated with entacapone, tolcapone, neuroleptics, antidepressants (except serotonin-specific reuptake inhibitors or imipramines \\[desipramine, imipramine, clomipramine and amitriptyline\\]), monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day) or antiemetics (except domperidone) within 4 weeks prior to randomisation;\n* Treated with apomorphine within 7 days prior to randomisation;\n* Treated with any investigational product within 2 months prior to randomisation (or within 5 half-lives, whichever is longer);\n* A psychiatric or any medical condition that might place him/her at increased risk or interfere with assessments;\n* Known hypersensitivity to any of the ingredients of the investigational products;\n* A history of abuse of alcohol, drugs or medications within the last 2 years;\n* A clinically relevant ECG abnormality;\n* A history or current evidence of heart disease, including but not limited to myocardial infarction, angina, congestive heart failure and cardiac arrhythmia;\n* Unstable concomitant disease being treated with changing doses of medication;\n* A history or current evidence of any relevant disease in the context of this study, i.e., with respect to the safety of the subject (e.g., hepatic or renal impairment) or related to the study conditions;\n* A test positive for the human immunodeficiency viruses (HIV) 1 or 2 antibodies, or hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb);\n* Donated blood or received blood or blood products within the 6 months prior to randomisation;\n* Pregnant, breast-feeding or of childbearing potential;\n* Other condition or circumstance that, in the opinion of the investigator, may compromise the subject\'s ability to comply with the study protocol.'}, 'identificationModule': {'nctId': 'NCT01568034', 'briefTitle': 'A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': "A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor", 'orgStudyIdInfo': {'id': 'BIA-91067-201'}, 'secondaryIdInfos': [{'id': '2008-003869-72', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence A', 'description': 'Treatment Sequence A Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo\n\nLevodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Placebo', 'Drug: Levodopa/Carbidopa', 'Drug: Levodopa/Benzerazide']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence B', 'description': '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\n\nLevodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Placebo', 'Drug: Levodopa/Carbidopa', 'Drug: Levodopa/Benzerazide']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence C', 'description': '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\n\nLevodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Placebo', 'Drug: Levodopa/Carbidopa', 'Drug: Levodopa/Benzerazide']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence D', 'description': '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\n\nLevodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Placebo', 'Drug: Levodopa/Carbidopa', 'Drug: Levodopa/Benzerazide']}], 'interventions': [{'name': 'BIA 9-1067', 'type': 'DRUG', 'otherNames': ['OPC, Opicapone'], 'description': 'BIA 9-1067 - 25 mg single-dose', 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B', 'Treatment Sequence C', 'Treatment Sequence D']}, {'name': 'BIA 9-1067', 'type': 'DRUG', 'otherNames': ['OPC, Opicapone'], 'description': 'BIA 9-1067 - 50 mg single-dose', 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B', 'Treatment Sequence C', 'Treatment Sequence D']}, {'name': 'BIA 9-1067', 'type': 'DRUG', 'otherNames': ['OPC, Opicapone'], 'description': 'BIA 9-1067 - 100 mg single-dose', 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B', 'Treatment Sequence C', 'Treatment Sequence D']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PLC'], 'description': 'single-dose', 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B', 'Treatment Sequence C', 'Treatment Sequence D']}, {'name': 'Levodopa/Carbidopa', 'type': 'DRUG', 'otherNames': ['Sinemet'], 'description': 'Levodopa 100 mg Carbidopa 25 mg', 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B', 'Treatment Sequence C', 'Treatment Sequence D']}, {'name': 'Levodopa/Benzerazide', 'type': 'DRUG', 'otherNames': ['Madopar®/Restex®'], 'description': 'Levodopa 100 mg Benzerazide 25 mg', 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B', 'Treatment Sequence C', 'Treatment Sequence D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Department of Neurology-Hospital de Santa Maria-Faculty of Medicine, University of Lisbon', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '020125', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic Colentina - Clinica de Neurologie', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '04050', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Department of Neurology- Hospital of the department of medical care of Ministry Internal Affairs of Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Joaquim Ferreira, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Santa Maria, Lisbon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}