Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-07 @ 5:09 AM
Study NCT ID:
NCT02171234
Status:
COMPLETED
Last Update Posted:
2015-01-07
First Post:
2014-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093
Sponsor:
Organization:
Raw JSON
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2-093 200 mg b.i.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 2 - BIA 2-093 400 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 400mg', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group 3 - BIA 2-093 800 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 800mg', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group 4 - BIA 2-093 1200 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 1200mg', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Mouth dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Muscle contractions involuntary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mucositis NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hepatic enzymes increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Skeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Concentration impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Dreaming abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Upper resp tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - BIA 2-093 200 mg b.i.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)'}, {'id': 'OG001', 'title': 'Group 2 - BIA 2-093 400 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 400mg'}, {'id': 'OG002', 'title': 'Group 3 - BIA 2-093 800 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 800mg'}, {'id': 'OG003', 'title': 'Group 4 - BIA 2-093 1200 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 1200mg'}], 'classes': [{'title': 'Cmax Day 1', 'categories': [{'measurements': [{'value': '3086', 'spread': '1342', 'groupId': 'OG000'}, {'value': '7827', 'spread': '1313', 'groupId': 'OG001'}, {'value': '11074', 'spread': '1919', 'groupId': 'OG002'}, {'value': '16071', 'spread': '2238', 'groupId': 'OG003'}]}]}, {'title': 'Cmax Day 8', 'categories': [{'measurements': [{'value': '6683', 'spread': '1576', 'groupId': 'OG000'}, {'value': '8824', 'spread': '1411', 'groupId': 'OG001'}, {'value': '18675', 'spread': '2613', 'groupId': 'OG002'}, {'value': '25457', 'spread': '2746', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 8', 'description': 'Cmax - Maximum observed plasma concentration', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-τ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - BIA 2-093 200 mg b.i.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)'}, {'id': 'OG001', 'title': 'Group 2 - BIA 2-093 400 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 400mg'}, {'id': 'OG002', 'title': 'Group 3 - BIA 2-093 800 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 800mg'}, {'id': 'OG003', 'title': 'Group 4 - BIA 2-093 1200 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 1200mg'}], 'classes': [{'title': 'AUC0-τ Day 1', 'categories': [{'measurements': [{'value': '22163', 'spread': '6216', 'groupId': 'OG000'}, {'value': '96262', 'spread': '17064', 'groupId': 'OG001'}, {'value': '159492', 'spread': '21695', 'groupId': 'OG002'}, {'value': '250426', 'spread': '27356', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-τ Day 8', 'categories': [{'measurements': [{'value': '63140', 'spread': '7997', 'groupId': 'OG000'}, {'value': '126308', 'spread': '14833', 'groupId': 'OG001'}, {'value': '268384', 'spread': '27683', 'groupId': 'OG002'}, {'value': '423003', 'spread': '45952', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose', 'description': 'AUC0-τ - Area under the plasma concentration time curve to last measurable time point\n\nDay 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose', 'unitOfMeasure': 'ng.h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Number of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - BIA 2-093 200 mg b.i.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)'}, {'id': 'OG001', 'title': 'Group 2 - BIA 2-093 400 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 400mg'}, {'id': 'OG002', 'title': 'Group 3 - BIA 2-093 800 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 800mg'}, {'id': 'OG003', 'title': 'Group 4 - BIA 2-093 1200 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 1200mg'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'PLC, Placebo'}], 'classes': [{'title': 'All Adverse Events', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'AE Considered Not Related to Treatment', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'AE Considered Possibly Related to Treatment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Adverse Events of Mild Severity', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Adverse Events of Moderate Severity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 20 weeks', 'description': 'Total Number of Adverse Events.', 'unitOfMeasure': 'Total Number of AE', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'PLC, Placebo'}, {'id': 'FG001', 'title': 'Group 1 - 200 mg b.i.d.', 'description': 'BIA 2-093 200mg (twice daily)'}, {'id': 'FG002', 'title': 'Group 2 - 400 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine 400mg'}, {'id': 'FG003', 'title': 'Group 3 - 800 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine 800mg'}, {'id': 'FG004', 'title': 'Group 4 - 1200 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine 1200mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'PLC, Placebo'}, {'id': 'BG001', 'title': 'Group 1 - BIA 2-093 200 mg b.i.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)'}, {'id': 'BG002', 'title': 'Group 2 - BIA 2-093 400 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 400mg'}, {'id': 'BG003', 'title': 'Group 3 - BIA 2-093 800 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 800mg'}, {'id': 'BG004', 'title': 'Group 4 - BIA 2-093 1200 mg o.d.', 'description': 'BIA 2-093, ESL, Eslicarbazepine acetate 1200mg'}, {'id': 'BG005', '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-19', 'studyFirstSubmitDate': '2014-06-20', 'resultsFirstSubmitDate': '2014-11-28', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-19', 'studyFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Adverse Events', 'timeFrame': 'up to 20 weeks', 'description': 'Total Number of Adverse Events.'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Day 1 and Day 8', 'description': 'Cmax - Maximum observed plasma concentration'}, {'measure': 'AUC0-τ', 'timeFrame': 'Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose', 'description': 'AUC0-τ - Area under the plasma concentration time curve to last measurable time point\n\nDay 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'BIA 2-093', 'Eslicarbazepine acetate'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and tolerability of multiple dose regimens of BIA 2-093 in healthy young male volunteers', 'detailedDescription': 'Single centre, Phase I, double-blind, randomised, placebo-controlled study investigating 4 multiple rising oral doses of BIA 2-093 in 4 groups of 8 young healthy male subjects. Within each group, 2 subjects were randomised to receive placebo and the remaining 6 subjects to receive BIA 2-093. No subject was a member of more than one group. The dose regimens investigated were: 200 mg b.i.d.(twice daily), 400 mg o.d.(once daily; this was changed from 400 mg b.i.d. in protocol amendment 1, on the basis of interim pharmacokinetic analysis of Group 1 data), 800 mg o.d, and 1200 mg o.d. BIA 2-093/placebo was administered orally once daily on Days 1-8, or twice a day (at 12-hour intervals) on Days 1-7 with a final dose in the morning of Day 8. The multiple dose regimens were to be investigated in ascending order. Progression to each higher dose level was only to occur if the previous dose level was deemed by the investigator and the sponsor to be safe and well tolerated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion Criteria:\n* Adult males aged 18-45 years, with a body mass index (BMI) of 19-28 kg/m2.\n* Subjects who were healthy as determined by pre-study medical history, physical examination, 12-lead ECG and EEG.\n* Subjects who had clinical laboratory tests acceptable to the investigator.\n* Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.\n* Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.\n* Subjects who were non-smokers or previous smokers who had not smoked for at least 6 months.\n* Subjects who were able and willing to give written informed consent.\n* Exclusion Criteria:\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, 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 relevant drug hypersensitivity (carbamazepine and\n* related compounds).\n* Subjects who had a history of alcoholism.\n* Subjects who had a history of drug abuse.\n* Subjects who consumed more than 28 units of alcohol a week.\n* Subjects who had a significant infection or known inflammatory process on screening and/or admission.\n* Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).\n* Subjects who had an acute infection such as influenza at the time of screening and/or admission.\n* Subjects who had used prescription drugs within 4 weeks of first dosing.\n* Subjects who had used over the counter medication, excluding routine vitamins but including mega dose vitamin therapy, within one week of dosing.\n* Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of admission to this study.\n* Subjects who had donated and/or received any blood or blood products within 3 months prior to screening.\n* Subjects who were vegetarians, vegans and/or had 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* Subjects who had previously received BIA 2-093.'}, 'identificationModule': {'nctId': 'NCT02171234', 'briefTitle': 'A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093, in Young Healthy Male Volunteers.', 'orgStudyIdInfo': {'id': 'BIA-2093-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1- 200 mg b.i.d. (twice daily)', 'description': 'BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.', 'interventionNames': ['Drug: Placebo', 'Drug: BIA 2-093']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - 400 mg b.i.d.', 'description': 'BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.', 'interventionNames': ['Drug: Placebo', 'Drug: BIA 2-093']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3- 800 mg o.d. (once daily)', 'description': 'BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.', 'interventionNames': ['Drug: Placebo', 'Drug: BIA 2-093']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 - either 800 mg b.i.d or 1200 mg o.d.', 'description': 'BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.', 'interventionNames': ['Drug: Placebo', 'Drug: BIA 2-093']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PLC, Placebo'], 'armGroupLabels': ['Group 1- 200 mg b.i.d. (twice daily)', 'Group 2 - 400 mg b.i.d.', 'Group 3- 800 mg o.d. (once daily)', 'Group 4 - either 800 mg b.i.d or 1200 mg o.d.']}, {'name': 'BIA 2-093', 'type': 'DRUG', 'otherNames': ['ESL, Eslicarbazepine acetate'], 'armGroupLabels': ['Group 1- 200 mg b.i.d. (twice daily)', 'Group 2 - 400 mg b.i.d.', 'Group 3- 800 mg o.d. (once daily)', 'Group 4 - either 800 mg b.i.d or 1200 mg o.d.']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 1YR', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Drug Research Unit", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}