Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT00592904
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2008-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551441', 'term': 'perampanel'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '888-422-4743', 'title': 'Eisai Inc.', 'organization': 'Eisai Call Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.', 'description': 'A subject who had the same TEAE more than once during the study was counted only once in the calculation of n (%) for that event.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'The participants who had previously received placebo during the double-blind study.', 'otherNumAtRisk': 84, 'otherNumAffected': 72, 'seriousNumAtRisk': 84, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Perampanel', 'description': 'The participants that had previously received perampanel during the double-blind study.', 'otherNumAtRisk': 178, 'otherNumAffected': 132, 'seriousNumAtRisk': 178, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'Painful Diabetic Neuropathy', 'description': 'The participants that were being treated for PDN in the double-blind study and received either placebo or perampanel.', 'otherNumAtRisk': 205, 'otherNumAffected': 160, 'seriousNumAtRisk': 205, 'seriousNumAffected': 31}, {'id': 'EG003', 'title': 'Post Herpetic Neuralgia', 'description': 'The participants that were being treated for PHN in the double-blind study and received either placebo or perampanel.', 'otherNumAtRisk': 57, 'otherNumAffected': 44, 'seriousNumAtRisk': 57, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Large intestinal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Neuropathic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Vascular encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V. 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG001', 'title': 'PDN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG002', 'title': 'Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG003', 'title': 'PHN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}], 'classes': [{'categories': [{'measurements': [{'value': '-10.5', 'spread': '8.41', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '9.65', 'groupId': 'OG001'}, {'value': '-9.0', 'spread': '6.72', 'groupId': 'OG002'}, {'value': '-9.8', 'spread': '10.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: All enrolled subjects (starting at Visit 1) who took at least 1 dose of study drug and had at least 1 efficacy assessment in this trial comprised the ITT Population. All efficacy analyses were performed on the ITT Population. One subject had a protocol violation after consenting and was withdrawn from treatment.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG001', 'title': 'PDN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG002', 'title': 'Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG003', 'title': 'PHN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}], 'classes': [{'categories': [{'measurements': [{'value': '-43.1', 'spread': '23.17', 'groupId': 'OG000'}, {'value': '-33.7', 'spread': '24.49', 'groupId': 'OG001'}, {'value': '-35.9', 'spread': '24.55', 'groupId': 'OG002'}, {'value': '-35.4', 'spread': '27.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG001', 'title': 'PDN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG002', 'title': 'Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG003', 'title': 'PHN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.57', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '1.29', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG001', 'title': 'PDN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG002', 'title': 'Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG003', 'title': 'PHN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}], 'classes': [{'title': 'Very much improved (1)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Much improved (2)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Minimally improved (3)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'No change (4)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Minimally worse (5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Much worse (6)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Very much worse (7)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 48', 'description': 'The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). \\[Please note high withdrawl rate during study\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit."}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG001', 'title': 'PDN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG002', 'title': 'Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'OG003', 'title': 'PHN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}], 'classes': [{'title': 'Physical Component Score', 'categories': [{'measurements': [{'value': '5.48', 'spread': '8.14', 'groupId': 'OG000'}, {'value': '5.14', 'spread': '9.36', 'groupId': 'OG001'}, {'value': '1.72', 'spread': '8.27', 'groupId': 'OG002'}, {'value': '2.18', 'spread': '9.30', 'groupId': 'OG003'}]}]}, {'title': 'Mental Component Score', 'categories': [{'measurements': [{'value': '0.40', 'spread': '8.90', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '10.62', 'groupId': 'OG001'}, {'value': '-1.53', 'spread': '10.77', 'groupId': 'OG002'}, {'value': '-3.12', 'spread': '12.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'FG001', 'title': 'PDN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'FG002', 'title': 'Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'FG003', 'title': 'PHN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '262', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'BG001', 'title': 'PDN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'BG002', 'title': 'Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'BG003', 'title': 'PHN: Prior Treatment of Perampanel', 'description': "All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '155', 'groupId': 'BG004'}]}]}, {'title': '≥65', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '225', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Race', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'dispFirstSubmitDate': '2012-08-23', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2008-01-03', 'dispFirstSubmitQcDate': '2012-08-23', 'resultsFirstSubmitDate': '2012-10-23', 'studyFirstSubmitQcDate': '2008-01-11', 'dispFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-06', 'studyFirstPostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.'}, {'measure': 'Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.', 'timeFrame': 'Baseline and Week 48', 'description': 'SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.'}, {'measure': 'Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).'}], 'secondaryOutcomes': [{'measure': 'Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)', 'timeFrame': 'Baseline and Week 48', 'description': 'The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). \\[Please note high withdrawl rate during study\\].'}, {'measure': 'Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT', 'timeFrame': 'Baseline and Week 48', 'description': 'Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.'}]}, 'conditionsModule': {'keywords': ['Neuralgia', 'neuropathy'], 'conditions': ['Neuralgia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEach patient must meet all of the following criteria to be enrolled in this study:\n\n1. Met and continues to meet all inclusion and none of the exclusion criteria for the preceding PDN or PHN study and received study drug or placebo under double-blind conditions.\n2. Completed the preceding double-blind study End of Treatment (EOT) Visit no more than 12 weeks prior to Baseline (Visit 1) for the open-label study. The eligibility status of patients who do not enroll during this 12 week period will be evaluated on a case by case basis via discussion between the Investigator and the Sponsor.\n3. Males and females ≥18 years of age. Female patients should be either of nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or intrauterine device \\[IUD\\]) for at least 1 month before the Baseline Visit (Visit 1) and for 1 month after the end of the study (Visit 16). They must also have a negative pregnancy test at Baseline (Visit 1). Female patients using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) throughout the study.\n4. Provide written informed consent prior to entering the study and prior to undergoing any study-related procedures.\n5. Is reliable, willing, and able to cooperate with the study procedures.\n\nExclusion Criteria:\n\nPatients who meet the following criterion will be excluded from this study:\n\n1. Patients who discontinued early for any reason from the preceding double-blind study.\n2. Patients who have a clinically significant finding(s) that would make them unsuitable for the study in the opinion of the investigator or Sponsor.'}, 'identificationModule': {'nctId': 'NCT00592904', 'briefTitle': 'Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Multi-Center, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)', 'orgStudyIdInfo': {'id': 'E2007-G000-228'}, 'secondaryIdInfos': [{'id': '2007-005495-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: E2007']}], 'interventions': [{'name': 'E2007', 'type': 'DRUG', 'otherNames': ['Perampanel'], 'description': 'Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Antonio Laurenza, M. D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}