Viewing Study NCT01679002

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Ignite Creation Date: 2025-12-25 @ 3:38 AM
Ignite Modification Date: 2026-03-03 @ 4:33 AM
Study NCT ID: NCT01679002
Status: COMPLETED
Last Update Posted: 2025-04-06
First Post: 2012-08-31
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C416835', 'term': 'eslicarbazepine acetate'}, {'id': 'D000078330', 'term': 'Oxcarbazepine'}], 'ancestors': [{'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jose.rocha@bial.com', 'phone': '+351 229 866 100', 'title': 'Head of Clinical Research', 'organization': 'Bial - Portela & Cª, S.A.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BIA 2-093 900 mg', 'description': 'ESL, Eslicarbazepine acetate BIA 2-093 900 mg od', 'otherNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BIA 2-093 450 mg Bid', 'description': 'ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid', 'otherNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Oxcarbazepine 450 mg Bid', 'description': 'OXC, Oxcarbazepine 450 mg bid', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Appetite lost', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Ejaculation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Erection increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Increased libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Diffuse macular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Frontal headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Orthostatic dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Concentration impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Motor dysfunction NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Numbness of limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Occipital headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Vasovagal reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Abdominal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dry lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Right upper quadrant pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Tooth pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax - Maximum Observed Plasma Drug Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 2-093 900 mg od', 'description': 'ESL, Eslicarbazepine acetate BIA 2-093 900 mg od'}, {'id': 'OG001', 'title': 'BIA 2-093 450 mg Bid', 'description': 'ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid'}, {'id': 'OG002', 'title': 'Oxcarbazepine 450 mg Bid', 'description': 'OXC, Oxcarbazepine 450 mg bid'}], 'classes': [{'title': 'Cmax (BIA 2-194)', 'categories': [{'measurements': [{'value': '22210', 'spread': '7257', 'groupId': 'OG000'}, {'value': '16667', 'spread': '3981', 'groupId': 'OG001'}, {'value': '12195', 'spread': '2053', 'groupId': 'OG002'}]}]}, {'title': 'Cmax (BIA 2-195)', 'categories': [{'measurements': [{'value': '685', 'spread': '188', 'groupId': 'OG000'}, {'value': '702', 'spread': '182', 'groupId': 'OG001'}, {'value': '2481', 'spread': '362', 'groupId': 'OG002'}]}]}, {'title': 'Cmax (Oxcarbazepine)', 'categories': [{'measurements': [{'value': '208', 'spread': '53.2', 'groupId': 'OG000'}, {'value': '182', 'spread': '47.2', 'groupId': 'OG001'}, {'value': '1080', 'spread': '548', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose', 'description': 'Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites:\n\nBIA 2-194 BIA 2-195 Oxcarbazepine', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The results are related to overall population in the study devided by period of treatment.'}, {'type': 'SECONDARY', 'title': 'AUC - Area Under the Plasma Concentration Versus Time Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 2-093 900 mg od', 'description': 'ESL, Eslicarbazepine acetate BIA 2-093 900 mg od'}, {'id': 'OG001', 'title': 'BIA 2-093 450 mg Bid', 'description': 'ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid'}, {'id': 'OG002', 'title': 'Oxcarbazepine 450 mg Bid', 'description': 'OXC, Oxcarbazepine 450 mg bid'}], 'classes': [{'title': 'AUC0-t (BIA 2-194)', 'categories': [{'measurements': [{'value': '381601', 'spread': '95368', 'groupId': 'OG000'}, {'value': '283014', 'spread': '74203', 'groupId': 'OG001'}, {'value': '268376', 'spread': '43294', 'groupId': 'OG002'}]}]}, {'title': 'AUC0-t (BIA 2-195)', 'categories': [{'measurements': [{'value': '20164', 'spread': '6790', 'groupId': 'OG000'}, {'value': '19091', 'spread': '6042', 'groupId': 'OG001'}, {'value': '48841', 'spread': '9041', 'groupId': 'OG002'}]}]}, {'title': 'AUC0-t (Oxcarbazepine)', 'categories': [{'measurements': [{'value': '3238', 'spread': '1033', 'groupId': 'OG000'}, {'value': '2699', 'spread': '909', 'groupId': 'OG001'}, {'value': '5196', 'spread': '1472', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose', 'description': 'AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites:\n\nBIA 2-194 BIA 2-195 Oxcarbazepine', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The results are related to overall population in the study devided by period of treatment.'}, {'type': 'SECONDARY', 'title': 'Number of of Subjects Reporting at Least One Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 2-093 900 mg od', 'description': 'ESL, Eslicarbazepine acetate BIA 2-093 900 mg od'}, {'id': 'OG001', 'title': 'BIA 2-093 450 mg Bid', 'description': 'ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid'}, {'id': 'OG002', 'title': 'Oxcarbazepine 450 mg Bid', 'description': 'OXC, Oxcarbazepine 450 mg bid'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Number of of subjects reporting at least one adverse event.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The results are related to overall population in the study devided by period of treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A', 'description': 'BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period.\n\nBIA 2-093 900 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid'}, {'id': 'FG001', 'title': 'Group B', 'description': 'BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period\n\nBIA 2-093 450 mg bid OXC 450 mg bid BIA 2-093 900 mg od'}, {'id': 'FG002', 'title': 'Group C', 'description': 'oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'BIA 2-093 900 mg Once-daily Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'BIA 2-093 450 mg Twice-daily Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Oxcarbazepine 450 mg Twice-daily Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A', 'description': 'BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid'}, {'id': 'BG001', 'title': 'Group B', 'description': 'BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 450 mg od'}, {'id': 'BG002', 'title': 'Group C', 'description': 'oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 450 mg od - BIA 2-093 450 mg bid'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2012-08-31', 'resultsFirstSubmitDate': '2014-11-28', 'studyFirstSubmitQcDate': '2012-08-31', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-31', 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Plasma Drug Concentration', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose', 'description': 'Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites:\n\nBIA 2-194 BIA 2-195 Oxcarbazepine'}], 'secondaryOutcomes': [{'measure': 'AUC - Area Under the Plasma Concentration Versus Time Curve', 'timeFrame': 'pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose', 'description': 'AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites:\n\nBIA 2-194 BIA 2-195 Oxcarbazepine'}, {'measure': 'Number of of Subjects Reporting at Least One Adverse Event', 'timeFrame': '8 weeks', 'description': 'Number of of subjects reporting at least one adverse event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Oxcarbazepine', 'Eslicarbazepine Acetate', 'BIA 2-093'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.', 'detailedDescription': 'Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:\n* Male or female subjects aged between 18 and 45 years, inclusive.\n* Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.\n* Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.\n* Subjects who had clinical laboratory tests clinically acceptable.\n* Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.\n* Subjects who were negative for alcohol and drugs of abuse at screening and first admission.\n* Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.\n* Subjects who were able and willing to give written informed consent.\n* If case of female subjects, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, who used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.\n* If case of female subjects, subjects who had a negative pregnancy test at screening and first admission.\n\nExclusion Criteria:\n\n* Subjects who did not conform to the above inclusion criteria.\n* Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.\n* Subjects who had a clinically relevant surgical history.\n* Subjects who had a clinically relevant family history.\n* Subjects who had a history of relevant atopy.\n* Subjects who had a history of hypersensitivity to carbamazepine or oxcarbazepine or any other relevant drug hypersensitivity.\n* Subjects who had a history of alcoholism or drug abuse.\n* Subjects who consumed more than 14 units of alcohol a week.\n* Subjects who had a significant infection or known inflammatory process on screening and/or first admission.\n* Subjects who had acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).\n* Subjects who had used prescription or over-the-counter medication within two weeks of first admission.\n* Subjects who had used any investigational drug and/or participated in any clinical trial within four months of their first admission.\n* Subjects who had previously received BIA 2-093.\n* Subjects who had donated and/or received any blood or blood products within the previous 4 months prior to screening.\n* Subjects who were vegetarians, vegans and/or have medical dietary restrictions.\n* Subjects who could not communicate reliably with the investigator.\n* Subjects who were unlikely to co-operate with the requirements of the study.\n* Subjects who were unwilling or unable to give written informed consent.\n* In case of female subjects, subjects who were pregnant or breast-feeding.\n* In case of female subjects, subjects who were of childbearing potential and did not use an approved effective contraceptive method or used oral contraceptives.'}, 'identificationModule': {'nctId': 'NCT01679002', 'briefTitle': 'Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BIA-2093-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period\n\nBIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid', 'interventionNames': ['Drug: BIA 2-093', 'Drug: Oxcarbazepine']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period\n\nBIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od', 'interventionNames': ['Drug: BIA 2-093', 'Drug: Oxcarbazepine']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period\n\nOXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid', 'interventionNames': ['Drug: BIA 2-093', 'Drug: Oxcarbazepine']}], 'interventions': [{'name': 'BIA 2-093', 'type': 'DRUG', 'otherNames': ['ESL, Eslicarbazepine acetate'], 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Oxcarbazepine', 'type': 'DRUG', 'otherNames': ['OXC, Trileptal®'], 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4745-457', 'city': 'S. Mamede Do Coronado', 'state': 'Trofa', 'country': 'Portugal', 'facility': 'BIAL - Portela & Cª S.A. - Human Pharmacology Unit (UFH)'}], 'overallOfficials': [{'name': 'Manuel Vaz-da-Silva, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BIAL - Portela & Cª S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}