Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT01146951
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2010-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065768', 'term': 'Lennox Gastaut Syndrome'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079703', 'term': 'rufinamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '888-422-4743', 'title': 'Eisai Inc.', 'organization': 'Eisai Call Center'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months', 'description': 'Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Rufinamide (E2080)', 'description': 'Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \\>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)', 'otherNumAtRisk': 29, 'otherNumAffected': 27, 'seriousNumAtRisk': 29, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.', 'otherNumAtRisk': 30, 'otherNumAffected': 21, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Anal Fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Aphthous Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gingival Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tooth injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Lactate Dehydrogenase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Pressure Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lymphocyte Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Joint Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Status Epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Autism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Complex Partial Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Psychomotor Hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tonic Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Stereotypy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Skin Chapped', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Heat Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Subcutaneous Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rufinamide (E2080)', 'description': 'Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \\>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.20', 'groupId': 'OG000', 'lowerLimit': '-93.5', 'upperLimit': '27.2'}, {'value': '-3.25', 'groupId': 'OG001', 'lowerLimit': '-81.6', 'upperLimit': '151.9'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-26.65', 'ciLowerLimit': '-40.30', 'ciUpperLimit': '-11.80', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (28 day observational period) and End of Treatment (28 day treatment period)', 'description': 'The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency" and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: \\[100 x (post-treatment value - baseline)/ baseline\\].\n\nThe frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.\n\nParticipants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rufinamide (E2080)', 'description': 'Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \\>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.'}], 'classes': [{'title': 'Yes (50% Reduction Achieved)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Fisher's exact test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': '50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.\n\nParticipants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Seizure Frequency (Per 28 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rufinamide (E2080)', 'description': 'Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \\>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.90', 'groupId': 'OG000', 'lowerLimit': '-87.3', 'upperLimit': '15.4'}, {'value': '-3.05', 'groupId': 'OG001', 'lowerLimit': '-52.2', 'upperLimit': '133.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann method', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-33.30', 'ciLowerLimit': '-47.10', 'ciUpperLimit': '-17.00', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (28 day observational period) and End of Treatment (28 day treatment period)', 'description': 'Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: \\[100 x (post-treatment value - baseline)/ baseline\\].', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.\n\nParticipants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rufinamide (E2080)', 'description': 'Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \\>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.'}], 'classes': [{'title': 'Partial Seizure Freq. % Change (n=4,6)', 'categories': [{'measurements': [{'value': '-52.20', 'groupId': 'OG000', 'lowerLimit': '-96.2', 'upperLimit': '-26.3'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '-28.2', 'upperLimit': '35.9'}]}]}, {'title': 'Absence Seizure Freq. % Change (n=1,0)', 'categories': [{'measurements': [{'value': '3.40', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '3.4'}, {'value': 'NA', 'comment': 'n=0 participants with absence seizures analyzed in Placebo arm', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Atyp. Absence Seizure Freq. % Change (n=12,19)', 'categories': [{'measurements': [{'value': '-59.00', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '107.1'}, {'value': '-21.10', 'groupId': 'OG001', 'lowerLimit': '-83.2', 'upperLimit': '253.5'}]}]}, {'title': 'Myoclonic Seizure Freq. % Change (n=10,10)', 'categories': [{'measurements': [{'value': '-52.35', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '53.3'}, {'value': '6.60', 'groupId': 'OG001', 'lowerLimit': '-46.1', 'upperLimit': '270.0'}]}]}, {'title': 'Clonic Seizure Freq. % Change (n=1,0)', 'categories': [{'measurements': [{'value': '-81.20', 'groupId': 'OG000', 'lowerLimit': '-81.2', 'upperLimit': '-81.2'}, {'value': 'NA', 'comment': 'n=0 participants with clonic seizures analyzed in Placebo arm', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Tonic Seizure Freq. % Change (n=28,28)', 'categories': [{'measurements': [{'value': '-24.20', 'groupId': 'OG000', 'lowerLimit': '-92.6', 'upperLimit': '42.8'}, {'value': '-3.60', 'groupId': 'OG001', 'lowerLimit': '-83.8', 'upperLimit': '274.8'}]}]}, {'title': 'Tonic-clonic Seizure Freq. % Change (n=2,10)', 'categories': [{'measurements': [{'value': '-57.35', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '-14.7'}, {'value': '2.35', 'groupId': 'OG001', 'lowerLimit': '-75.8', 'upperLimit': '450.0'}]}]}, {'title': 'Atonic Seizure Freq. % Change (n=10,12)', 'categories': [{'measurements': [{'value': '-63.10', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '68.8'}, {'value': '-6.10', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '2195.7'}]}]}, {'title': 'Uncla. Epileptic Seizure Freq. % Change (n=1,0)', 'categories': [{'measurements': [{'value': '-88.70', 'groupId': 'OG000', 'lowerLimit': '-88.7', 'upperLimit': '-88.7'}, {'value': 'NA', 'comment': 'n=0 participants with unclassified epileptic seizures analyzed in Placebo arm', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann method', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-57.15', 'ciLowerLimit': '-104.50', 'ciUpperLimit': '-17.30', 'groupDescription': 'Analysis for Partial Seizure Frequency', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann method', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-28.65', 'ciLowerLimit': '-72.00', 'ciUpperLimit': '0.90', 'groupDescription': 'Analysis of atypical absence seizure frequency', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann method', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-54.35', 'ciLowerLimit': '-126.60', 'ciUpperLimit': '-15.40', 'groupDescription': 'Analysis for myoclonic seizure frequency', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann method', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-23.20', 'ciLowerLimit': '-40.70', 'ciUpperLimit': '-5.60', 'groupDescription': 'Analysis of tonic seizure frequency', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann method', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-71.40', 'ciLowerLimit': '-464.70', 'ciUpperLimit': '30.50', 'groupDescription': 'Analysis for Tonic-clonic seizure frequency', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.221', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann method', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-52.10', 'ciLowerLimit': '-89.10', 'ciUpperLimit': '10.80', 'groupDescription': 'Analysis of Atonic seizure frequency', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (28 day observational period) and End of Treatment (28 day treatment period)', 'description': 'Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: \\[100 x (post-treatment value - baseline)/ baseline\\].\n\nSeizures analyzed other than tonic-atonic seizures included:\n\nPartial seizure freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, \\& Uncla. (unclassified) epileptic seizure.\n\nThe frequency of epileptic seizures was recorded in the diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.\n\nParticipants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Change (CGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rufinamide (E2080)', 'description': 'Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \\>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.'}], 'classes': [{'title': 'Week 12: Markedly improved (n=25, 29)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Improved (n=25, 29)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Slightly Improved (n=25, 29)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Unchanged (n=25, 29)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Slightly Worsened (n=25, 29)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Worsened (n=25, 29)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Markedly Worsened (n=25, 29)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOCF: Markedly Improved (n=28, 30)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOCF: Improved (n=28, 30)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LOCF: Slightly Improved (n=28, 30)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'LOCF: Unchanged (n=28, 30)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'LOCF: Slightly Worsened (n=28, 30)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LOCF: Worsened (n=28, 30)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LOCF: Markedly Worsened (n=28, 30)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of Week 12 of the Treatment Period', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of final assessment (LOCF)', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12 of the treatment period', 'description': "CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward \\[LOCF\\]) \\& at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation \\[d/c\\]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period).\n\nThe CGIC was assessed according to the following 7-grade scale based on the frequency \\& severity of seizures, AEs, and overall conditions of daily life.\n\nMarkedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.\n\nParticipants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rufinamide (E2080)', 'description': 'Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.\n\nTarget maintenance dose:\n\n15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \\>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Of n= 66 who started Observation Period, 7 discontinued from study. Primary reasons were deviation of the inclusion/ exclusion criteria (n=5), untoward event before study treatment (n=1) \\& other (n=1). Of 59 participants, 58 were included in full analysis set (FAS). 1 participant (E2080 group) was excluded due to inappropriate diagnosis of disease.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rufinamide (E2080)', 'description': 'Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \\>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '13.9', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '14.9', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One subject from the Rufinamide (E2080) group was excluded from the FAS because of the inappropriate diagnosis of the disease, dropping the total number from 29 to 28 participants.'}}, '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': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2010-06-14', 'resultsFirstSubmitDate': '2013-05-13', 'studyFirstSubmitQcDate': '2010-06-17', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-29', 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)', 'timeFrame': 'Baseline (28 day observational period) and End of Treatment (28 day treatment period)', 'description': 'The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency" and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: \\[100 x (post-treatment value - baseline)/ baseline\\].\n\nThe frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency', 'timeFrame': '12 weeks', 'description': '50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency.'}, {'measure': 'Percent Change in Total Seizure Frequency (Per 28 Days)', 'timeFrame': 'Baseline (28 day observational period) and End of Treatment (28 day treatment period)', 'description': 'Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: \\[100 x (post-treatment value - baseline)/ baseline\\].'}, {'measure': 'Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)', 'timeFrame': 'Baseline (28 day observational period) and End of Treatment (28 day treatment period)', 'description': 'Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: \\[100 x (post-treatment value - baseline)/ baseline\\].\n\nSeizures analyzed other than tonic-atonic seizures included:\n\nPartial seizure freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, \\& Uncla. (unclassified) epileptic seizure.\n\nThe frequency of epileptic seizures was recorded in the diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner.'}, {'measure': 'Clinical Global Impression of Change (CGIC)', 'timeFrame': 'Up to Week 12 of the treatment period', 'description': "CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward \\[LOCF\\]) \\& at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation \\[d/c\\]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period).\n\nThe CGIC was assessed according to the following 7-grade scale based on the frequency \\& severity of seizures, AEs, and overall conditions of daily life.\n\nMarkedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened."}]}, 'conditionsModule': {'keywords': ['Epilepsy', 'Seizures'], 'conditions': ['Lennox-Gastaut Syndrome']}, 'referencesModule': {'references': [{'pmid': '33825230', 'type': 'DERIVED', 'citation': 'Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.'}, {'pmid': '33179247', 'type': 'DERIVED', 'citation': 'Panebianco M, Prabhakar H, Marson AG. Rufinamide add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Nov 8;11(11):CD011772. doi: 10.1002/14651858.CD011772.pub3.'}]}, 'descriptionModule': {'briefSummary': 'To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Participants who are diagnosed as Lennox-Gastaut syndrome with tonic/atonic seizures and atypical absence seizures (A history of atypical absence seizures will also be incorporated).\n2. Participants who had a slow spike-and-wave pattern in an electroencephalogram within 6 months prior to the enrollment for the Observation Period.\n3. Participants who had at least a total of 90 seizures in the 28 days prior to the enrollment for the Observation Period.\n4. Participants who have been on 1 - 3 anti-epileptic drugs from 28 days prior to the enrollment for the Observation Period and have not changed the type of the anti-epileptic drugs.\n5. Participants who have not changed the type nor the dose or administration of the anti-epileptic drugs they are taking in the Observation Period.\n\nExclusion criteria;\n\n1. Participants who had a history of generalized tonic-clonic status epilepticus within baseline.\n2. Participants who received drug therapy at least 4 times to be rescued from status epilepticus within baseline.\n3. Participants who had a history of hypoxia which needed emergency resuscitation within 12 months prior to the Treatment Period.\n4. Participants who were on a ketogenic diet or have received adrenocorticotropic hormone (ACTH) therapy or Vitamin B6 therapy within 6 months prior to the Treatment Period.\n5. Participants who had a history of suicide attempt within the 1 year prior to the Treatment Period.\n6. Participants who had a history of or has an allergy to triazole compound.\n7. Participants who have clinically significant electrocardiogram abnormalities at baseline.\n8. Participants who are pregnant, who may be pregnant, who are lactating or who wish to be pregnant.'}, 'identificationModule': {'nctId': 'NCT01146951', 'briefTitle': 'A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients', 'orgStudyIdInfo': {'id': 'E2080-J081-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rufinamide (E2080)', 'interventionNames': ['Drug: Rufinamide (E2080)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rufinamide (E2080)', 'type': 'DRUG', 'otherNames': ['E2080'], 'description': 'Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.\n\nTarget maintenance dose:\n\n15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \\>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)', 'armGroupLabels': ['Rufinamide (E2080)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Goshi-shi', 'state': 'Kumamoto', 'country': 'Japan'}, {'city': 'Iwamuma-shi', 'state': 'Miyagi', 'country': 'Japan'}, {'city': 'Omura-shi', 'state': 'Nagasaki', 'country': 'Japan'}, {'city': 'Nara', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Niigata', 'state': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Yufu-shi', 'state': 'Oita Prefecture', 'country': 'Japan'}, {'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Neyagawa', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76615, 'lon': 135.62759}}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan'}, {'city': 'Moriya-shi', 'state': 'Shiga', 'country': 'Japan'}, {'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Kodaira-shi', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Kokubunji-shi', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Toyoma-shi', 'state': 'Toyama', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Hiroki Takano', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}