Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-04 @ 12:21 AM
Study NCT ID:
NCT01398956
Status:
COMPLETED
Last Update Posted:
2017-08-15
First Post:
2011-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1887822', 'title': 'UCB (Study Director)', 'phoneExt': '9493', 'organization': 'UCB Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 4.7 years).', 'description': 'Advers events refers to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Levetiracetam (SS)', 'description': "Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study", 'otherNumAtRisk': 44, 'otherNumAffected': 41, 'seriousNumAtRisk': 44, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 138, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 16, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 32, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 40, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 21, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Skin erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}], 'seriousEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Medical observation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Fracture malunion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Breast adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Monoplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}, {'term': 'Scoliosis surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment Emergent Adverse Events During the Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam (SS)', 'description': "Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study"}], 'classes': [{'categories': [{'measurements': [{'value': '626', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 3 years', 'unitOfMeasure': 'Treatment Emergent Adverse Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.'}, {'type': 'SECONDARY', 'title': 'The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam (FAS)', 'description': "Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study"}], 'classes': [{'categories': [{'measurements': [{'value': '-92.07', 'groupId': 'OG000', 'lowerLimit': '-97.16', 'upperLimit': '-64.64'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Treatment Period (up to 4.8 years)', 'description': 'Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation:\n\nPercentage change from Baseline = ((A-B)/B)\\*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all subjects with evaluable baseline and post-baseline values of generalized tonic-clonic (GTC) seizure frequency as the efficacy analysis, excluding those patients who seriously violated Good Clinical Practice (GCP).'}, {'type': 'SECONDARY', 'title': 'The Incidence of Adverse Drug Reactions During the Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam (SS)', 'description': "Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study"}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.', 'unitOfMeasure': 'Adverse Drug Reactions', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levetiracetam', 'description': "Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'AE, non-serious non-fatal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal Criteria No.3', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Subject moved a long distance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study started to enroll subjects in Japan in June 2011.', 'preAssignmentDetails': 'Participant Flow refers to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Levetiracetam', 'description': "Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study"}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 Years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'spread': '13.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Baseline Characteristics refer to the Safety Set (SS) which consisted of all subjects who took at least one dose of study medication in this study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-06', 'studyFirstSubmitDate': '2011-07-13', 'resultsFirstSubmitDate': '2016-09-29', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-27', 'studyFirstPostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment Emergent Adverse Events During the Entire Study Period', 'timeFrame': 'Through study completion, an average of 3 years'}], 'secondaryOutcomes': [{'measure': 'The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).', 'timeFrame': 'During the Treatment Period (up to 4.8 years)', 'description': 'Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation:\n\nPercentage change from Baseline = ((A-B)/B)\\*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period.'}, {'measure': 'The Incidence of Adverse Drug Reactions During the Entire Study Period', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Levetiracetam', 'Epilepsy', 'Generalized tonic-clonic seizures'], 'conditions': ['Epilepsy', 'Generalized Tonic-clonic Seizures']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.\n* The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators\n\nExclusion Criteria:\n\n* Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible'}, 'identificationModule': {'nctId': 'NCT01398956', 'briefTitle': 'An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) Seizures', 'orgStudyIdInfo': {'id': 'N01361'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levetiracetam', 'description': 'Twice daily (morning and evening) orally', 'interventionNames': ['Drug: Levetiracetam']}], 'interventions': [{'name': 'Levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra, E Keppra'], 'description': 'formulation: tablet or dry syrup\n\nstrength: 250 mg tablet, 500 mg tablet, dry syrup 50%\n\ndosage: Sb ≥16 years and ≥4 and \\<16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and \\<16 years (\\<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day\n\nfrequency: twice daily', 'armGroupLabels': ['Levetiracetam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fujisawa', 'country': 'Japan', 'facility': '152', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': '112', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': '113', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': '165', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': '166', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'country': 'Japan', 'facility': '187', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Gifu', 'country': 'Japan', 'facility': '107', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Himeji', 'country': 'Japan', 'facility': '162', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': '110', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': '117'}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': '130'}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': '176'}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': '143', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': '156', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kodaira', 'country': 'Japan', 'facility': '120', 'geoPoint': {'lat': 35.72603, 'lon': 139.48508}}, {'city': 'Kokubunji', 'country': 'Japan', 'facility': '105', 'geoPoint': {'lat': 35.70222, 'lon': 139.47556}}, {'city': 'Kōshi', 'country': 'Japan', 'facility': '306', 'geoPoint': {'lat': 32.89271, 'lon': 130.77567}}, {'city': 'Miyazaki', 'country': 'Japan', 'facility': '172', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Miyazaki', 'country': 'Japan', 'facility': '179', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': '305', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Niigata', 'country': 'Japan', 'facility': '106', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Niigata', 'country': 'Japan', 'facility': '153', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Okayama', 'country': 'Japan', 'facility': '109', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'country': 'Japan', 'facility': '174', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saitama', 'country': 'Japan', 'facility': '119', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Sakai', 'country': 'Japan', 'facility': '147', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'city': 'Sakai', 'country': 'Japan', 'facility': '194', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': '304', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Tochigi', 'country': 'Japan', 'facility': '138', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': '184', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': '190', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Ube', 'country': 'Japan', 'facility': '111', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}