Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-04-08 @ 11:59 AM
Study NCT ID:
NCT00988156
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Sponsor:
Organization:
Raw JSON
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'otherNumAffected': 94, 'seriousNumAtRisk': 129, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Esl (Safety Set Part I)', 'otherNumAtRisk': 134, 'otherNumAffected': 112, 'seriousNumAtRisk': 134, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'COELIAC DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'DEVICE MALFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'DRUG WITHDRAWAL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'BRONCHOPNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'INFECTIOUS MONONUCLEOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'BRAIN HERNIATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'BRAIN OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'EPILEPSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'GRAND MAL CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'HYDROCEPHALUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'HYPOTONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PARTIAL SEIZURES WITH SECONDARY GENERALISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'STATUS EPILEPTICUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ASPHYXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'VASCULAR PURPURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'MEDICAL DEVICE CHANGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Seizure Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matching placebo'}, {'id': 'OG001', 'title': 'Esl (BIA 2-093)', 'description': 'Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'spread': '186.19', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '72.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2490', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Visit 7', 'description': 'Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.', 'unitOfMeasure': 'seizures/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Responder Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matching placebo'}, {'id': 'OG001', 'title': 'Esl (BIA 2-093)', 'description': 'Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9017', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline up to Visit 7', 'description': 'Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matching placebo'}, {'id': 'FG001', 'title': 'Esl (BIA 2-093)', 'description': 'Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'Intention-to-Treat Set (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'Per Protocol Set (PP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}], 'recruitmentDetails': '73 clinical centres in 20 countries Date first patient enrolled: 07 Dec 2007. Date last patient completed the double-blind treatment period (Part I): 20 Aug 2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matching placebo'}, {'id': 'BG001', 'title': 'Esl (BIA 2-093)', 'description': 'Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL or matching placebo. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '2-6 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': '7-11 years', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': '12-18 years', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2009-10-01', 'resultsFirstSubmitDate': '2014-05-09', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-16', 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Seizure Frequency', 'timeFrame': 'Baseline up to Visit 7', 'description': 'Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.'}, {'measure': 'Responder Rate', 'timeFrame': 'baseline up to Visit 7', 'description': 'Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Partial', 'Refractory', 'Children', 'Adolescents', 'Adjunctive', 'Randomised', 'Double-blind', 'Placebo-controlled', 'Parallel-group'], 'conditions': ['Partial Epilepsy in Children and Adolescents']}, 'referencesModule': {'references': [{'pmid': '31878820', 'type': 'DERIVED', 'citation': 'Mintz M, Pina-Garza JE, Wolf SM, McGoldrick PE, Jozwiak S, Grinnell T, Cantu D, Costa R, Moreira J, Li Y, Blum D. Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures. J Child Neurol. 2020 Mar;35(4):265-273. doi: 10.1177/0883073819890997. Epub 2019 Dec 26.'}], 'seeAlsoLinks': [{'url': 'https://www.bial.com/en/r_d.2/transparency.208/clinical_trials.209/eslicarbazepine_acetate.210.html', 'label': 'Sponsor Web page for Clinical Trials Transparency'}, {'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001887-55/results', 'label': 'EU Clinical Trials Register: Clinical Trial Results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.', 'detailedDescription': 'Partial epilepsy, the commonest form of epilepsy, is a difficult condition to treat with many patients continuing to have symptoms despite trying several medications. Lack of efficacy and adverse effects are commonly associated with current anti-epileptic drugs.\n\nThis study will examine the efficacy in addition to safety and tolerability of a new anti-epileptic drug, Eslicarbazepine acetate (BIA 2-093), as an adjunctive therapy for refractory partial seizures in children.\n\nThe primary analysis variables are:\n\n* The responder rate (the proportion of patients with at least a 50% reduction in standardised seizure frequency)\n* The relative reduction in standardised seizure frequency'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* girls of child-bearing potential have to follow reliable and medically acceptable contraceptive method throughout the study\n* diagnosis of epilepsy for at least 6 months prior to enrolment\n* at least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs\n* at least 4 partial-onset seizures during each 4-week interval of the 8-week baseline period\n* previous treatment with three or more AEDs, in their maximum tolerated doses, for at least one month, without seizure control\n* current treatment with 1 or 2 AEDs (any except oxcarbazepine); if present, vagus nerve stimulation is considered an AED\n* stable dose regimen of AEDs during the 8-week baseline period\n* cooperation and willingness to complete all aspects of the study, including hospitalisation if required\n* written informed consent to participate in the study in accordance with local legislation\n\nExclusion Criteria:\n\n* primarily generalised seizures\n* baseline seizure frequency substantially different from usual seizure frequency\n* known progressive neurological disorders\n* history of status epilepticus within the 3 months prior to enrolment\n* seizures of non-epileptic origin\n* Lennon-Gastaut\n* West syndrome\n* Major psychiatric disorders\n* Previous treatment any study with Eslicarbazepine acetate'}, 'identificationModule': {'nctId': 'NCT00988156', 'briefTitle': 'Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children', 'orgStudyIdInfo': {'id': 'BIA-2093-305'}, 'secondaryIdInfos': [{'id': '2007-001887-55', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Eslicarbazepine acetate', 'description': 'To receive Eslicarbazepine acetate in addition to concomitant therapy', 'interventionNames': ['Drug: Eslicarbazepine acetate (BIA 2-093)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'To receive placebo in addition to concomitant therapy', 'interventionNames': ['Drug: Eslicarbazepine acetate']}], 'interventions': [{'name': 'Eslicarbazepine acetate (BIA 2-093)', 'type': 'DRUG', 'otherNames': ['BIA 2093'], 'description': 'Part I - 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.\n\nThe recommended target dose of double-blind study treatment will be 20mg/kg/day.\n\nPart II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.', 'armGroupLabels': ['Eslicarbazepine acetate']}, {'name': 'Eslicarbazepine acetate', 'type': 'DRUG', 'otherNames': ['BIA 2093'], 'description': 'Part I: 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.\n\nPart II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Ambulanz für Neuropädiatrie und Entwicklungsdiagnostik, Med. 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