Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT00490035
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2007-06-21
Is NOT Gene Therapy:
True
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': 'UCB 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day', 'otherNumAtRisk': 100, 'otherNumAffected': 22, 'seriousNumAtRisk': 100, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day', 'otherNumAtRisk': 99, 'otherNumAffected': 31, 'seriousNumAtRisk': 99, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day', 'otherNumAtRisk': 99, 'otherNumAffected': 35, 'seriousNumAtRisk': 99, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day', 'otherNumAtRisk': 100, 'otherNumAffected': 37, 'seriousNumAtRisk': 100, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 31, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 26, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], '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': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '5.12'}, {'value': '1.34', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '3.12'}, {'value': '1.49', 'groupId': 'OG002', 'lowerLimit': '0.69', 'upperLimit': '2.78'}, {'value': '1.26', 'groupId': 'OG003', 'lowerLimit': '0.52', 'upperLimit': '2.93'}]}]}], 'analyses': [{'pValue': '=0.261', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Reduction over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '16.9', 'groupDescription': 'In order to control the Type I error testing was performed in sequence starting with 50 mg, then 100 mg and finally 20 mg Brivaracetam per day versus Placebo, only moving to the next test if the previous one was significant at the 5 % level.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures.', 'unitOfMeasure': 'Seizure Frequency per Week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'title': 'Non-responders', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}, {'value': '72.7', 'groupId': 'OG002'}, {'value': '64.0', 'groupId': 'OG003'}]}]}, {'title': 'Responders', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}, {'value': '27.3', 'groupId': 'OG002'}, {'value': '36.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week.\n\nThe Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a \\>= 50 % reduction in seizure frequency per week from Baseline.', '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.'}, {'type': 'SECONDARY', 'title': 'All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '5.61'}, {'value': '1.34', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '3.12'}, {'value': '1.49', 'groupId': 'OG002', 'lowerLimit': '0.69', 'upperLimit': '2.78'}, {'value': '1.26', 'groupId': 'OG003', 'lowerLimit': '0.52', 'upperLimit': '2.93'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III).', 'unitOfMeasure': 'Times per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.'}, {'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': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.03', 'groupId': 'OG000', 'lowerLimit': '-40.27', 'upperLimit': '17.59'}, {'value': '-30.03', 'groupId': 'OG001', 'lowerLimit': '-55.99', 'upperLimit': '-2.11'}, {'value': '-26.83', 'groupId': 'OG002', 'lowerLimit': '-60.05', 'upperLimit': '6.32'}, {'value': '-32.45', 'groupId': 'OG003', 'lowerLimit': '-72.51', 'upperLimit': '0.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) \\* 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction.', 'unitOfMeasure': 'Percent change in seizures per week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.'}, {'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': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'title': '<= 25 %', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}, {'value': '15.2', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}]}]}, {'title': '- 25 % to < 25 %', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '33.0', 'groupId': 'OG003'}]}]}, {'title': '25 % to < 50 %', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}, {'value': '24.2', 'groupId': 'OG002'}, {'value': '21.0', 'groupId': 'OG003'}]}]}, {'title': '50 % to < 75 %', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}, {'value': '17.2', 'groupId': 'OG002'}, {'value': '14.0', 'groupId': 'OG003'}]}]}, {'title': '75 % to < 100 %', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}, {'value': '18.0', 'groupId': 'OG003'}]}]}, {'title': '100 %', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}, {'value': '4.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The categories are:\n\n* \\<= 25 %\n* \\- 25 % to \\< 25 %\n* 25 % to \\< 50 %\n* 50 % to \\< 75 %\n* 75 % to \\< 100 %\n* 100 %', '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.'}, {'type': 'SECONDARY', 'title': 'Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'title': 'Seizure free', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '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': '98.0', 'groupId': 'OG001'}, {'value': '99.0', 'groupId': 'OG002'}, {'value': '96.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the 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.'}, {'type': 'SECONDARY', 'title': 'Time to First Type I Seizure During the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '8'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '10'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The time to first Type I Seizure during the 12-week Treatment Period was measured in days.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Time to Fifth Type I Seizure During the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '25'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '34'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '32'}, {'value': '24', 'groupId': 'OG003', 'lowerLimit': '18', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Time to Tenth Type I Seizure During the 12-week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '50'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '64'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '33', 'upperLimit': '49'}, {'value': '46', 'groupId': 'OG003', 'lowerLimit': '34', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.'}, {'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': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}, {'value': '47.2', 'groupId': 'OG001'}, {'value': '62.5', 'groupId': 'OG002'}, {'value': '41.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 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': '91', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '2.29', 'spread': '14.03', 'groupId': 'OG000'}, {'value': '4.50', 'spread': '12.71', 'groupId': 'OG001'}, {'value': '3.09', 'spread': '14.43', 'groupId': 'OG002'}, {'value': '1.78', 'spread': '13.95', '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': 'Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.'}, {'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': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '8.25', 'spread': '22.01', 'groupId': 'OG000'}, {'value': '6.23', 'spread': '17.97', 'groupId': 'OG001'}, {'value': '5.34', 'spread': '23.81', 'groupId': 'OG002'}, {'value': '8.04', 'spread': '26.26', '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': 'Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.'}, {'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': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.09', 'spread': '20.26', 'groupId': 'OG000'}, {'value': '3.35', 'spread': '19.72', 'groupId': 'OG001'}, {'value': '3.09', 'spread': '20.79', 'groupId': 'OG002'}, {'value': '3.50', 'spread': '22.52', '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': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.54', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '3.89', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '3.82', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '3.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. 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. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the 12-week Treatment Period in Hospital Depression Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.65', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '3.67', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '3.84', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '3.69', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. 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. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation Visit.'}, {'type': 'SECONDARY', 'title': "Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '4.93', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '5.17', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '5.04', 'spread': '1.29', 'groupId': 'OG002'}, {'value': '5.47', 'spread': '1.16', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last Visit or Early Discontinuation Visit in the 12-week Treatment Period', 'description': 'The 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 not mentally impaired had to complete it by answering the following question: "Overall, has there been a change in your seizures since the start of the study medication?"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.'}, {'type': 'SECONDARY', 'title': "Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '4.78', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '4.99', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '4.99', 'spread': '1.10', 'groupId': 'OG002'}, {'value': '5.34', 'spread': '1.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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 reference time point. The Investigator was to complete it by answering the following question: "Assess the Overall change in the severity of patient\'s illness, compared to start of study medication."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.'}, {'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': '92', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '3.49', 'spread': '19.22', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '17.04', 'groupId': 'OG001'}, {'value': '1.95', 'spread': '20.74', 'groupId': 'OG002'}, {'value': '1.99', 'spread': '20.42', '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': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.'}, {'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': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '3.80', 'spread': '18.71', 'groupId': 'OG000'}, {'value': '3.75', 'spread': '15.94', 'groupId': 'OG001'}, {'value': '3.13', 'spread': '19.35', 'groupId': 'OG002'}, {'value': '-2.45', 'spread': '18.55', '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': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.'}, {'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': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '1.80', 'spread': '19.16', 'groupId': 'OG000'}, {'value': '5.36', 'spread': '20.69', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '19.95', 'groupId': 'OG002'}, {'value': '0.69', 'spread': '16.66', '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': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.'}, {'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': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '28.93', 'groupId': 'OG000'}, {'value': '3.64', 'spread': '29.24', 'groupId': 'OG001'}, {'value': '-0.85', 'spread': '24.36', 'groupId': 'OG002'}, {'value': '3.00', 'spread': '28.22', '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': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.'}, {'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': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '5.11', 'spread': '18.48', 'groupId': 'OG000'}, {'value': '4.52', 'spread': '16.73', 'groupId': 'OG001'}, {'value': '4.55', 'spread': '18.93', 'groupId': 'OG002'}, {'value': '2.24', 'spread': '18.45', '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': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.'}, {'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': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'OG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'OG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'OG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '19.8', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '18.1', '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': 'Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'FG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'FG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'FG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'AE, non-serious non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'AE, serious fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Serious adverse event (SAE), non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'AE of unknown type', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study started to enroll subjects in September 2007 and concluded in February 2009.', 'preAssignmentDetails': 'Participant Flow refers to the Randomized Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '399', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day'}, {'id': 'BG001', 'title': 'Brivaracetam 20 mg/Day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day'}, {'id': 'BG002', 'title': 'Brivaracetam 50 mg/Day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day'}, {'id': 'BG003', 'title': 'Brivaracetam 100 mg/Day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day'}, {'id': 'BG004', 'title': 'Total Title'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '35.7', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '39.0', 'spread': '13.5', 'groupId': 'BG002'}, {'value': '38.0', 'spread': '13.1', 'groupId': 'BG003'}, {'value': '37.24', 'spread': '13.05', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '383', 'groupId': 'BG004'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '228', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hungary', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to the 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': 399}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'dispFirstSubmitDate': '2010-02-24', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-14', 'studyFirstSubmitDate': '2007-06-21', 'dispFirstSubmitQcDate': '2010-02-24', 'resultsFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2007-06-21', 'dispFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-14', 'studyFirstPostDateStruct': {'date': '2007-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures.'}], 'secondaryOutcomes': [{'measure': 'Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week.\n\nThe Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a \\>= 50 % reduction in seizure frequency per week from Baseline.'}, {'measure': 'All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III).'}, {'measure': 'Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) \\* 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction.'}, {'measure': 'Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The categories are:\n\n* \\<= 25 %\n* \\- 25 % to \\< 25 %\n* 25 % to \\< 50 %\n* 50 % to \\< 75 %\n* 75 % to \\< 100 %\n* 100 %'}, {'measure': 'Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.'}, {'measure': 'Time to First Type I Seizure During the 12-week Treatment Period', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The time to first Type I Seizure during the 12-week Treatment Period was measured in days.'}, {'measure': 'Time to Fifth Type I Seizure During the 12-week Treatment Period', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days.'}, {'measure': 'Time to Tenth Type I Seizure During the 12-week Treatment Period', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days.'}, {'measure': 'Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.', 'timeFrame': 'From 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': '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 Seizure Worry 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 Daily Activities/Social 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 Hospital Anxiety Score', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. 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. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.'}, {'measure': 'Change From Baseline to the 12-week Treatment Period in Hospital Depression Score', 'timeFrame': 'From Baseline to 12-week Treatment Period', 'description': 'The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. 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. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.'}, {'measure': "Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit", 'timeFrame': 'Last Visit or Early Discontinuation Visit in the 12-week Treatment Period', 'description': 'The 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 not mentally impaired had to complete it by answering the following question: "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': '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 reference time point. The Investigator was to complete it by answering the following question: "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'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '24256083', 'type': 'RESULT', 'citation': 'Ryvlin P, Werhahn KJ, Blaszczyk B, Johnson ME, Lu S. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):47-56. doi: 10.1111/epi.12432. Epub 2013 Oct 28.'}, {'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.'}, {'pmid': '33461041', 'type': 'DERIVED', 'citation': 'Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.'}]}, '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 from 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\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 drugs (AEDs). Vagal nerve stimulation 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': 'NCT00490035', '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': 'A Multi-center, 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': 'N01252'}, 'secondaryIdInfos': [{'id': '2006-006344-59', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo tablets administered twice a day', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Brivaracetam 20 mg/day', 'description': 'Brivaracetam 20 mg/day, 10 mg administered twice a day', 'interventionNames': ['Drug: Brivaracetam']}, {'type': 'EXPERIMENTAL', 'label': 'Brivaracetam 50 mg/day', 'description': 'Brivaracetam 50 mg/day, 25 mg administered twice a day', 'interventionNames': ['Drug: Brivaracetam']}, {'type': 'EXPERIMENTAL', 'label': 'Brivaracetam 100 mg/day', 'description': 'Brivaracetam 100 mg/day, 50 mg administered twice a day', 'interventionNames': ['Drug: Brivaracetam']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period', 'armGroupLabels': ['Placebo']}, {'name': 'Brivaracetam', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Brivaracetam 20 mg/day']}, {'name': 'Brivaracetam', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Brivaracetam 50 mg/day']}, {'name': 'Brivaracetam', 'type': 'DRUG', 'description': 'Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.', 'armGroupLabels': ['Brivaracetam 100 mg/day']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': '13', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'La Louvière', 'country': 'Belgium', 'facility': '19', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'city': 'Liège', 'country': 'Belgium', 'facility': '12', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Sankt Vith', 'country': 'Belgium', 'facility': '10', 'geoPoint': {'lat': 50.28146, 'lon': 6.12724}}, {'city': 'Kuopio', 'country': 'Finland', 'facility': '44', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Oulu', 'country': 'Finland', 'facility': '41', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Seinäjoki', 'country': 'Finland', 'facility': '42', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'city': 'Tampere', 'country': 'Finland', 'facility': '43', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Angers', 'country': 'France', 'facility': '60', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Béthune', 'country': 'France', 'facility': '56', 'geoPoint': {'lat': 50.52965, 'lon': 2.64003}}, {'city': 'Bron', 'country': 'France', 'facility': '62', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Dijon', 'country': 'France', 'facility': '57', 'geoPoint': {'lat': 47.31344, 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