Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT00464269
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2007-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Sponsor:
Organization:
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': 'C482793', 'term': 'brivaracetam'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'Clinical Trial Call Center', 'organization': 'UCB'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).', 'description': 'Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day', 'otherNumAtRisk': 98, 'otherNumAffected': 32, 'seriousNumAtRisk': 98, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BRV 5 mg/Day', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day', 'otherNumAtRisk': 97, 'otherNumAffected': 49, 'seriousNumAtRisk': 97, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'BRV 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day', 'otherNumAtRisk': 100, 'otherNumAffected': 46, 'seriousNumAtRisk': 100, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'BRV 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day', 'otherNumAtRisk': 101, 'otherNumAffected': 51, 'seriousNumAtRisk': 101, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Aspiration bronchial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Brain hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.15', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '4.15'}, {'value': '1.80', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': '5.59'}, {'value': '1.96', 'groupId': 'OG002', 'lowerLimit': '1.05', 'upperLimit': '5.45'}, {'value': '1.70', 'groupId': 'OG003', 'lowerLimit': '0.91', 'upperLimit': '4.80'}]}]}], 'analyses': [{'pValue': '=0.025', 'groupIds': ['OG000', 'OG003'], 'paramType': '% reduction over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.8', 'ciLowerLimit': '1.7', 'ciUpperLimit': '22.6', 'estimateComment': 'The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.', 'groupDescription': 'The treatment difference between each Brivaracetam (BRV) dose and Placebo (PBO) is reported as a percent reduction over Placebo. The treatment effect was estimated using the 95 % confidence intervals.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'statisticalComment': 'Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to a 7-day duration.', 'nonInferiorityComment': 'The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.'}, {'pValue': '=0.492', 'groupIds': ['OG000', 'OG002'], 'paramType': '% reduction over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '-8.1', 'ciUpperLimit': '15.0', 'estimateComment': 'The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.', 'groupDescription': 'The treatment difference between each Brivaracetam dose an Placebo is reported as a percent reduction over Placebo. The treatment effect was estimated using 95 % confidence intervals.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'statisticalComment': 'Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to 7-day duration.', 'nonInferiorityComment': 'The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'Partial (Type I) seizures can be classified into one of the following three groups:\n\n* Simple partial seizures\n* Complex partial seizures\n* Partial seizures evolving to generalized tonic-clonic convulsions.\n\nPartial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as:\n\n(Total Type I seizures over the TP)\\*7/(Total number of days with no missing seizure count in the TP)', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'title': 'Responders', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}, {'title': 'Non-responders', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.15', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '4.23'}, {'value': '1.80', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': '5.59'}, {'value': '1.96', 'groupId': 'OG002', 'lowerLimit': '1.05', 'upperLimit': '5.85'}, {'value': '1.77', 'groupId': 'OG003', 'lowerLimit': '0.99', 'upperLimit': '4.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'There are three different types of seizures:\n\n* Type I: Partial seizures\n* Type II: Generalized seizures\n* Type III: Unclassified epileptic seizures.\n\nAll seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)\\*7/(Total number of days with no missing seizure count in the TP)', 'unitOfMeasure': 'seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.75', 'groupId': 'OG000', 'lowerLimit': '-5.11', 'upperLimit': '37.07'}, {'value': '19.95', 'groupId': 'OG001', 'lowerLimit': '-12.96', 'upperLimit': '45.15'}, {'value': '22.52', 'groupId': 'OG002', 'lowerLimit': '-4.56', 'upperLimit': '46.51'}, {'value': '30.47', 'groupId': 'OG003', 'lowerLimit': '11.40', 'upperLimit': '59.78'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'Percent change from Baseline was calculated as percent reduction by:\n\n(weekly seizure frequency Baseline - weekly seizure frequency Treatment)\\*100/(weekly seizure frequency Baseline).\n\nThe higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline.', 'unitOfMeasure': 'Percent change in POS frequency', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'title': '<-25 %', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '21.9', 'groupId': 'OG001'}, {'value': '14.1', 'groupId': 'OG002'}, {'value': '9.9', 'groupId': 'OG003'}]}]}, {'title': '-25 % to < 25 %', 'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000'}, {'value': '31.3', 'groupId': 'OG001'}, {'value': '38.4', 'groupId': 'OG002'}, {'value': '31.7', 'groupId': 'OG003'}]}]}, {'title': '25 % to < 50 %', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '24.2', 'groupId': 'OG002'}, {'value': '25.7', 'groupId': 'OG003'}]}]}, {'title': '50 % to < 75 %', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '15.2', 'groupId': 'OG002'}, {'value': '19.8', 'groupId': 'OG003'}]}]}, {'title': '75 % to < 100 %', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}, {'value': '8.9', 'groupId': 'OG003'}]}]}, {'title': '100 %', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}, {'value': '4.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: \\<-25 %, -25 % to \\<25 %, 25 % to \\<50 %, 50 % to \\<75 %, 75 % to \\<100 %, and 100 %.\n\nSubjects having zero for Baseline seizure frequency per week were classified in the \\<-25 % category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'title': 'Seizure-free', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '4.0', 'groupId': 'OG003'}]}]}, {'title': 'No seizures but non-completer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Not seizure-free', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '99.0', 'groupId': 'OG001'}, {'value': '98.0', 'groupId': 'OG002'}, {'value': '96.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:\n\n(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Time to First Type I Seizure During the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '7'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Time to Fifth Type I Seizure During the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '16'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '18'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '21'}, {'value': '19', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Time to Tenth Type I Seizure During the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '33'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '38'}, {'value': '34', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '46'}, {'value': '37', 'groupId': 'OG003', 'lowerLimit': '27', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '77.8', 'groupId': 'OG002'}, {'value': '63.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.\n\nType IC Population consists of those subjects with at least one Type IC seizure during the Baseline period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.88', 'spread': '14.44', 'groupId': 'OG000'}, {'value': '4.07', 'spread': '15.40', 'groupId': 'OG001'}, {'value': '5.19', 'spread': '15.47', 'groupId': 'OG002'}, {'value': '2.88', 'spread': '13.53', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.\n\nThe subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.36', 'spread': '26.98', 'groupId': 'OG000'}, {'value': '3.34', 'spread': '19.20', 'groupId': 'OG001'}, {'value': '3.69', 'spread': '24.55', 'groupId': 'OG002'}, {'value': '5.97', 'spread': '21.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.\n\nThe subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.97', 'spread': '28.39', 'groupId': 'OG000'}, {'value': '7.03', 'spread': '23.47', 'groupId': 'OG001'}, {'value': '7.73', 'spread': '26.04', 'groupId': 'OG002'}, {'value': '2.06', 'spread': '23.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.\n\nThe subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.44', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '7.32', 'spread': '4.03', 'groupId': 'OG001'}, {'value': '6.55', 'spread': '3.94', 'groupId': 'OG002'}, {'value': '7.99', 'spread': '3.63', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Hospital Depression Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.36', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '4.97', 'spread': '4.00', 'groupId': 'OG001'}, {'value': '4.82', 'spread': '3.56', 'groupId': 'OG002'}, {'value': '5.81', 'spread': '3.70', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': "Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'title': 'Marked improvement', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}, {'value': '18.8', 'groupId': 'OG002'}, {'value': '26.7', 'groupId': 'OG003'}]}]}, {'title': 'Moderate improvement', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}, {'value': '26.3', 'groupId': 'OG002'}, {'value': '19.8', 'groupId': 'OG003'}]}]}, {'title': 'Slight improvement', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}, {'value': '21.3', 'groupId': 'OG002'}, {'value': '22.1', 'groupId': 'OG003'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '27.5', 'groupId': 'OG002'}, {'value': '23.3', 'groupId': 'OG003'}]}]}, {'title': 'Slight worsening', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}, {'value': '4.7', 'groupId': 'OG003'}]}]}, {'title': 'Moderate worsening', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Marked worsening', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}, {'value': '2.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period', 'description': "Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': "Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'title': 'Marked improvement', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '17.2', 'groupId': 'OG002'}, {'value': '16.3', 'groupId': 'OG003'}]}]}, {'title': 'Moderate improvement', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '18.9', 'groupId': 'OG001'}, {'value': '18.2', 'groupId': 'OG002'}, {'value': '27.6', 'groupId': 'OG003'}]}]}, {'title': 'Slight improvement', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '24.4', 'groupId': 'OG001'}, {'value': '31.3', 'groupId': 'OG002'}, {'value': '24.5', 'groupId': 'OG003'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000'}, {'value': '34.4', 'groupId': 'OG001'}, {'value': '32.3', 'groupId': 'OG002'}, {'value': '25.5', 'groupId': 'OG003'}]}]}, {'title': 'Slight worsening', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'Moderate worsening', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3.1', 'groupId': 'OG003'}]}]}, {'title': 'Marked worsening', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period', 'description': "The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.41', 'spread': '19.55', 'groupId': 'OG000'}, {'value': '2.24', 'spread': '23.10', 'groupId': 'OG001'}, {'value': '3.94', 'spread': '15.56', 'groupId': 'OG002'}, {'value': '0.45', 'spread': '20.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.14', 'spread': '18.28', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '21.61', 'groupId': 'OG001'}, {'value': '2.07', 'spread': '19.10', 'groupId': 'OG002'}, {'value': '1.97', 'spread': '17.29', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'spread': '20.34', 'groupId': 'OG000'}, {'value': '4.26', 'spread': '21.23', 'groupId': 'OG001'}, {'value': '6.36', 'spread': '24.61', 'groupId': 'OG002'}, {'value': '3.37', 'spread': '19.16', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '34.05', 'groupId': 'OG000'}, {'value': '-2.61', 'spread': '28.08', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '25.94', 'groupId': 'OG002'}, {'value': '6.07', 'spread': '30.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.49', 'spread': '16.25', 'groupId': 'OG000'}, {'value': '3.39', 'spread': '19.70', 'groupId': 'OG001'}, {'value': '3.66', 'spread': '20.10', 'groupId': 'OG002'}, {'value': '2.33', 'spread': '19.14', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Intention-to-Treat (Placebo Treated Subjects)', 'description': 'Matching Placebo tablets administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG001', 'title': 'Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG002', 'title': 'Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}, {'id': 'OG003', 'title': 'Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day.\n\nThe modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '23.5', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '21.1', 'groupId': 'OG002'}, {'value': '5.5', 'spread': '20.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'FG001', 'title': 'BRV 5 mg/Day', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day'}, {'id': 'FG002', 'title': 'BRV 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'FG003', 'title': 'BRV 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'AE, serious fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'SAE, non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'AE, non-serious non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'SAE,non-fatal+AE,non-serious non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study started to enroll subjects in September 2007 and concluded in January 2009. 400 subjects were randomized of which 396 are included in the Safety Population.', 'preAssignmentDetails': 'Participant Flow refers to the Randomized Set (RS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'BG001', 'title': 'BRV 5 mg/Day', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day'}, {'id': 'BG002', 'title': 'BRV 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'BG003', 'title': 'BRV 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'BG004', 'title': 'Total Title'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '38.8', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '37.3', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '39.0', 'spread': '12.3', 'groupId': 'BG003'}, {'value': '38.2', 'spread': '12.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 18 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': '18 - < 65 years', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}, {'value': '380', 'groupId': 'BG004'}]}]}, {'title': '65 - < 85 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '198', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to Randomized Set.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'nctId': 'NCT03532516', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2022-07', 'dispFirstSubmitDate': '2010-02-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2007-04-19', 'dispFirstSubmitQcDate': '2010-02-01', 'resultsFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2007-04-20', 'dispFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-14', 'studyFirstPostDateStruct': {'date': '2007-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'Partial (Type I) seizures can be classified into one of the following three groups:\n\n* Simple partial seizures\n* Complex partial seizures\n* Partial seizures evolving to generalized tonic-clonic convulsions.\n\nPartial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as:\n\n(Total Type I seizures over the TP)\\*7/(Total number of days with no missing seizure count in the TP)'}], 'secondaryOutcomes': [{'measure': 'Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.'}, {'measure': 'All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'There are three different types of seizures:\n\n* Type I: Partial seizures\n* Type II: Generalized seizures\n* Type III: Unclassified epileptic seizures.\n\nAll seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)\\*7/(Total number of days with no missing seizure count in the TP)'}, {'measure': 'Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'Percent change from Baseline was calculated as percent reduction by:\n\n(weekly seizure frequency Baseline - weekly seizure frequency Treatment)\\*100/(weekly seizure frequency Baseline).\n\nThe higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline.'}, {'measure': 'Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: \\<-25 %, -25 % to \\<25 %, 25 % to \\<50 %, 50 % to \\<75 %, 75 % to \\<100 %, and 100 %.\n\nSubjects having zero for Baseline seizure frequency per week were classified in the \\<-25 % category.'}, {'measure': 'Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:\n\n(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)'}, {'measure': 'Time to First Type I Seizure During the 12-week Treatment Period', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period.'}, {'measure': 'Time to Fifth Type I Seizure During the 12-week Treatment Period', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period.'}, {'measure': 'Time to Tenth Type I Seizure During the 12-week Treatment Period', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period.'}, {'measure': 'Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.\n\nThe subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.\n\nThe subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.\n\nThe subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Hospital Depression Score', 'timeFrame': 'Baseline to 12-week Treatment Period', 'description': 'The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.'}, {'measure': "Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit", 'timeFrame': 'Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period', 'description': "Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'"}, {'measure': "Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit", 'timeFrame': 'Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period', 'description': "The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'"}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Brivaracetam', 'Partial Onset Seizures, Adolescents & Adults'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '24446953', 'type': 'RESULT', 'citation': 'Biton V, Berkovic SF, Abou-Khalil B, Sperling MR, Johnson ME, Lu S. Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: a phase III randomized, double-blind, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):57-66. doi: 10.1111/epi.12433. Epub 2013 Nov 8.'}, {'pmid': '27265725', 'type': 'RESULT', 'citation': 'Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.'}, {'pmid': '27335114', 'type': 'RESULT', 'citation': 'Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.'}, {'pmid': '27589414', 'type': 'RESULT', 'citation': "Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18."}, {'pmid': '28004320', 'type': 'RESULT', 'citation': 'Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.'}, {'pmid': '27608437', 'type': 'RESULT', 'citation': 'Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.'}, {'pmid': '28236727', 'type': 'RESULT', 'citation': 'Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.'}, {'pmid': '27988967', 'type': 'RESULT', 'citation': 'Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained >/=50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.'}, {'pmid': '28279891', 'type': 'RESULT', 'citation': 'Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27.'}, {'pmid': '29414542', 'type': 'RESULT', 'citation': 'Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.'}, {'pmid': '29908435', 'type': 'RESULT', 'citation': 'Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.'}, {'pmid': '32432339', 'type': 'RESULT', 'citation': 'Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.'}, {'pmid': '34218211', 'type': 'RESULT', 'citation': 'Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.'}, {'pmid': '35582748', 'type': 'RESULT', 'citation': 'Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V. Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials. Epilepsia. 2022 Aug;63(8):2024-2036. doi: 10.1111/epi.17304. Epub 2022 Jun 10.'}, {'pmid': '35285519', 'type': 'DERIVED', 'citation': 'Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.'}, {'pmid': '34155568', 'type': 'DERIVED', 'citation': 'Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21.'}], 'seeAlsoLinks': [{'url': 'https://www.briviact.com/briviact-PI.pdf?v=1479491757', 'label': 'Product Information'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects were 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted\n* Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification\n* Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)\n* Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1 (V1)\n* Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period\n* Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drug(s) (AEDs). Vagal nerve stimulation (VNS) was allowed and was not counted as a concomitant AED\n\nExclusion Criteria:\n\n* History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3\n* History or presence of status epilepticus during the year preceding Visit 1 or during Baseline'}, 'identificationModule': {'nctId': 'NCT00464269', 'briefTitle': 'Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures', 'orgStudyIdInfo': {'id': 'N01253'}, 'secondaryIdInfos': [{'id': '2006-006345-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Brivaracetam 5 mg/day', 'description': 'Brivaracetam 5 mg/day, 2.5 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg /day in a double-blinded way for the 12-week Treatment Period.', 'interventionNames': ['Drug: Brivaracetam 2.5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'BRV 20mg/day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period.', 'interventionNames': ['Drug: Brivaracetam 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'BRV 50mg/day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day, in a double-blinded way for the 12-week Treatment Period.', 'interventionNames': ['Drug: Brivaracetam 25 mg']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': '* Active Substance: Placebo\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 2.5 mg, 10 mg and 25 mg\n* Route of Administration: Oral use', 'armGroupLabels': ['Placebo']}, {'name': 'Brivaracetam 2.5 mg', 'type': 'DRUG', 'description': '* Active Substance: Brivaracetam\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 2.5 mg\n* Route of Administration: Oral use', 'armGroupLabels': ['Brivaracetam 5 mg/day']}, {'name': 'Brivaracetam 10 mg', 'type': 'DRUG', 'description': '* Active Substance: Brivaracetam\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 10 mg\n* Route of Administration: Oral use', 'armGroupLabels': ['BRV 20mg/day']}, {'name': 'Brivaracetam 25 mg', 'type': 'DRUG', 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