Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-02-17 @ 11:14 PM
Study NCT ID:
NCT01618695
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551441', 'term': 'perampanel'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eisai-chiken_hotline@hhc.eisai.co.jp', 'title': 'Inquiry Service.', 'organization': 'Eisai Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)', 'description': 'Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \\& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Core Phase: Placebo', 'description': 'Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).', 'otherNumAtRisk': 176, 'deathsNumAtRisk': 176, 'otherNumAffected': 114, 'seriousNumAtRisk': 176, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Core Phase: Perampanel 4 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.', 'otherNumAtRisk': 176, 'deathsNumAtRisk': 176, 'otherNumAffected': 119, 'seriousNumAtRisk': 176, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Core Phase: Perampanel 8 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 127, 'seriousNumAtRisk': 175, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Core Phase: Perampanel 12 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.', 'otherNumAtRisk': 180, 'deathsNumAtRisk': 180, 'otherNumAffected': 155, 'seriousNumAtRisk': 180, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG004', 'title': 'Extension Phase: Perampanel 12 mg', 'description': 'Participants received the same dose of perampanel in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). This dose was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). Participants who received perampanel matched-placebo in Core Phase were given perampanel 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). All participants were allowed to have their dose down or up titrated until an optimal dose was reached. A maintenance period was followed by conversion period in which participants received perampanel dose of 12 mg, orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country.', 'otherNumAtRisk': 679, 'deathsNumAtRisk': 679, 'otherNumAffected': 618, 'seriousNumAtRisk': 679, 'deathsNumAffected': 7, 'seriousNumAffected': 113}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysmetropsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Keratoconjunctivitis sicca', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Normal tension glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Retinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 42, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 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'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 679, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).'}, {'id': 'OG001', 'title': 'Perampanel 4 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'OG002', 'title': 'Perampanel 8 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'OG003', 'title': 'Perampanel 12 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.76', 'groupId': 'OG000', 'lowerLimit': '-90.4', 'upperLimit': '400.0'}, {'value': '-17.32', 'groupId': 'OG001', 'lowerLimit': '-97.1', 'upperLimit': '473.4'}, {'value': '-28.95', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '809.4'}, {'value': '-38.03', 'groupId': 'OG003', 'lowerLimit': '-100.0', 'upperLimit': '456.8'}]}]}], 'analyses': [{'pValue': '0.2330', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.09', 'ciLowerLimit': '-14.112', 'ciUpperLimit': '4.519', 'estimateComment': 'Median Difference to placebo and the 95 percent (%) confidence interval are based on the Hodges-Lehmann method.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.45', 'ciLowerLimit': '-25.683', 'ciUpperLimit': '-7.251', 'estimateComment': 'Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.95', 'ciLowerLimit': '-33.878', 'ciUpperLimit': '-16.235', 'estimateComment': 'Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 19', 'description': "Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data.'}, {'type': 'SECONDARY', 'title': 'Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).'}, {'id': 'OG001', 'title': 'Perampanel 4 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'OG002', 'title': 'Perampanel 8 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'OG003', 'title': 'Perampanel 12 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}, {'value': '36.0', 'groupId': 'OG002'}, {'value': '43.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3954', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 19', 'description': 'Responder rate was percentage of participants with greater than or equal to (\\>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (\\<) 50%, then the participants are considered as non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data.'}, {'type': 'SECONDARY', 'title': 'Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).'}, {'id': 'OG001', 'title': 'Perampanel 4 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'OG002', 'title': 'Perampanel 8 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'OG003', 'title': 'Perampanel 12 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.70', 'groupId': 'OG000', 'lowerLimit': '-88.6', 'upperLimit': '400.0'}, {'value': '-19.08', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '410.0'}, {'value': '-33.68', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '1103.4'}, {'value': '-41.80', 'groupId': 'OG003', 'lowerLimit': '-100.0', 'upperLimit': '456.8'}]}]}], 'analyses': [{'pValue': '0.0552', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.27', 'ciLowerLimit': '-18.067', 'ciUpperLimit': '1.671', 'estimateComment': 'Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.21', 'ciLowerLimit': '-30.941', 'ciUpperLimit': '-11.368', 'estimateComment': 'Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.65', 'ciLowerLimit': '-37.698', 'ciUpperLimit': '-19.794', 'estimateComment': 'Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 19', 'description': 'Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).'}, {'id': 'OG001', 'title': 'Perampanel 4 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'OG002', 'title': 'Perampanel 8 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'OG003', 'title': 'Perampanel 12 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 19', 'description': "The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Core Phase: Placebo; Extension Phase: up to 12 mg Perampanel', 'description': 'Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks) in the Core Phase. Participants received placebo in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 2 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.'}, {'id': 'FG001', 'title': 'Core Phase: Perampanel 4 mg; Extension Phase: up to 12 mg Perampanel', 'description': 'Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally, once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period in Core Phase was 19 weeks. Participants received the same dose of perampanel 4 mg in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 4 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.'}, {'id': 'FG002', 'title': 'Core Phase: Perampanel 8 mg; Extension Phase: up to 12 mg Perampanel', 'description': 'Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally, once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 8 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 8 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.'}, {'id': 'FG003', 'title': 'Core Phase/Extension Phase: up to 12 mg Perampanel', 'description': 'Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally, once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 12 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period) and continued receiving perampanel 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.'}], 'periods': [{'title': 'Core Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '177'}, {'groupId': 'FG003', 'numSubjects': '180'}]}, {'type': 'Treated (Safety Analysis Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '175'}, {'groupId': 'FG003', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '147'}, {'groupId': 'FG003', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who completed Core Phase and gave consent, entered the Extension Phase.', 'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'comment': 'Participants who completed Core Phase and gave consent, entered the Extension Phase.', 'groupId': 'FG002', 'numSubjects': '146'}, {'comment': 'Participants who completed Core Phase and gave consent, entered the Extension Phase.', 'groupId': 'FG003', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '92'}, {'groupId': 'FG003', 'numSubjects': '97'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 119 investigative sites in Australia, China, Korea, Japan, Malaysia, Taiwan, and Thailand from 15th May 2012 to 28th May 2020. A total of 940 participants were enrolled and screened, of which 230 participants were screen failures, 710 participants were randomized and 707 participants were treated in this study.', 'preAssignmentDetails': 'This study included Core and Extension Phase. Core Phase consisted of 2 phases: Prerandomization (Baseline) and Randomization (Titration, Maintenance Period). Extension Phase consisted of 3 periods: Preconversion, Conversion, Maintenance Period. Participants received varying doses depending on which dose level they were assigned to in Core Phase and their individual tolerance but in Extension Phase, all participants were up-titrated to single target dose level of 12 milligram (mg) per day.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}, {'value': '707', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Core Phase: Placebo', 'description': 'Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).'}, {'id': 'BG001', 'title': 'Core Phase: Perampanel 4 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'BG002', 'title': 'Core Phase: Perampanel 8 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'BG003', 'title': 'Core Phase: Perampanel 12 mg', 'description': 'Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'spread': '13.21', 'groupId': 'BG000'}, {'value': '33.1', 'spread': '13.18', 'groupId': 'BG001'}, {'value': '33.6', 'spread': '14.11', 'groupId': 'BG002'}, {'value': '32.3', 'spread': '12.30', 'groupId': 'BG003'}, {'value': '33.4', 'spread': '13.21', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '361', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '346', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}, {'value': '705', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}, {'value': '667', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set (SAS) included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one post-dose safety assessment.'}}, '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': 940}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2012-06-11', 'resultsFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-20', 'studyFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)', 'timeFrame': 'Baseline, Week 19', 'description': "Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness."}], 'secondaryOutcomes': [{'measure': 'Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Week 19', 'description': 'Responder rate was percentage of participants with greater than or equal to (\\>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (\\<) 50%, then the participants are considered as non-responders.'}, {'measure': 'Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)', 'timeFrame': 'Baseline, Week 19', 'description': 'Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.'}, {'measure': 'Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores', 'timeFrame': 'Baseline, Week 19', 'description': "The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Partial-onset Seizures', 'partial seizures', 'seizure', 'epilepsy'], 'conditions': ['Partial-onset Seizures']}, 'referencesModule': {'references': [{'pmid': '37059702', 'type': 'DERIVED', 'citation': 'Bresnahan R, Hill RA, Wang J. Perampanel add-on for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD010961. doi: 10.1002/14651858.CD010961.pub2.'}, {'pmid': '29250772', 'type': 'DERIVED', 'citation': 'Nishida T, Lee SK, Inoue Y, Saeki K, Ishikawa K, Kaneko S. Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study. Acta Neurol Scand. 2018 Apr;137(4):392-399. doi: 10.1111/ane.12883. Epub 2017 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Male or female and greater than or equal to 12 years of age;\n2. Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures\n3. Participants with computed tomography (CT) or magnetic resonance imaging (MRI) diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to visit 1 that ruled out progressive central nervous system (CNS) disorders, example, neurodegenerative disorders, brain tumors. For participants without existing CT or MRI results, CT or MRI was performed at or after Visit 1 but results evaluation was performed by Visit 2\n4. Participants who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard antiepileptic drug (AED) for 2 years before enrollment\n5. During the 6-week Prerandomization Phase participants must have had greater than or equal to 5 partial seizures per 6-week\n6. Are currently being treated with stable doses and administrations of 1, 2, or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as carbamazepine, phenytoin or oxcarbazepine only) out of the maximum of 3 AEDs is allowed\n\nExclusion Criteria\n\n1. Presence of nonmotor simple partial seizures only;\n2. Presence of primary generalized epilepsies or seizures, such as absences and/or myoclonic epilepsies;\n3. Presence or previous history of Lennox-Gastaut syndrome;\n4. A history of status epilepticus within 1 year prior to screening\n5. Seizure clusters where individual seizures cannot be counted\n6. A history of psychogenic seizures within 5 years prior to screening'}, 'identificationModule': {'nctId': 'NCT01618695', 'briefTitle': 'A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures', 'orgStudyIdInfo': {'id': 'E2007-J000-335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perampanel', 'interventionNames': ['Drug: Perampanel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Perampanel', 'type': 'DRUG', 'otherNames': ['E2007'], 'description': 'Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day.\n\nExtension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day.', 'armGroupLabels': ['Perampanel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Core study: Week 0 to Week 18 Once daily placebo.\n\nExtension study:\n\nWeek 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bedford Park', 'country': 'Australia', 'facility': 'Facility #1', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Camperdown', 'country': 'Australia', 'facility': 'Facility #1', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'city': 'Clayton', 'country': 'Australia', 'facility': 'Facility #1', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Fitzroy', 'country': 'Australia', 'facility': 'Facility #1', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'city': 'Heidelberg', 'country': 'Australia', 'facility': 'Facility #1', 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