Viewing Study NCT01634360

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Ignite Creation Date: 2025-12-25 @ 2:06 AM
Ignite Modification Date: 2026-01-24 @ 7:50 AM
Study NCT ID: NCT01634360
Status: TERMINATED
Last Update Posted: 2014-07-09
First Post: 2012-07-03
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, '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}, 'limitationsAndCaveats': {'description': 'Due to early termination, no subjects completed this open-label extension study.'}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Perampanel (Placebo During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.', 'otherNumAtRisk': 48, 'otherNumAffected': 3, 'seriousNumAtRisk': 48, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.', 'otherNumAtRisk': 134, 'otherNumAffected': 0, 'seriousNumAtRisk': 134, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Muscle Rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}], 'seriousEvents': [{'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'On and off phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Freezing phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hyperkinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Psycomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Muscle rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Posture abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Sensation of heaviness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Humerous fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Radial nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Benign ovarian tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Prostrate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Arterial stenosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Blood alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Blood pressure decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Heamatocrit decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Investigation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Obstructive uropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Social stay hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Deep brain stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perampanel (Placebo During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}, {'id': 'OG001', 'title': 'Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '2.811', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '2.479', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '2.913', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '2.907', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-1.05', 'spread': '2.760', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '2.754', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '2.638', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '2.959', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '3.443', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '2.881', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'categories': [{'measurements': [{'value': '-1.31', 'spread': '2.547', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '3.106', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'categories': [{'measurements': [{'value': '-1.14', 'spread': '3.121', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '3.149', 'groupId': 'OG001'}]}]}, {'title': 'Week 130', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '3.710', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '2.953', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '-1.00', 'spread': '2.953', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '2.672', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156', 'description': 'OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population- All subjects who were in the Safety Population and for whom at least 1 postbaseline (post Week 0) efficacy assessment was made.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perampanel (Placebo During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}, {'id': 'OG001', 'title': 'Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '0.85', 'spread': '2.856', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '3.562', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.47', 'spread': '3.200', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '3.758', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '1.89', 'spread': '3.712', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '3.632', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '1.40', 'spread': '3.895', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '4.153', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '0.81', 'spread': '4.101', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '4.238', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'categories': [{'measurements': [{'value': '1.39', 'spread': '4.450', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '4.625', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'categories': [{'measurements': [{'value': '0.21', 'spread': '4.541', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '4.617', 'groupId': 'OG001'}]}]}, {'title': 'Week 130', 'categories': [{'measurements': [{'value': '-0.98', 'spread': '4.276', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '4.013', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '4.105', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '4.974', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156', 'description': 'ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perampanel (Placebo During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}, {'id': 'OG001', 'title': 'Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '2.30', 'spread': '6.360', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '7.501', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.45', 'spread': '6.926', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '7.137', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '2.43', 'spread': '7.247', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '7.912', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '2.69', 'spread': '8.177', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '9.602', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '2.76', 'spread': '6.947', 'groupId': 'OG000'}, {'value': '3.83', 'spread': '9.084', 'groupId': 'OG001'}]}]}, {'title': 'Week 78', 'categories': [{'measurements': [{'value': '3.64', 'spread': '7.279', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '9.344', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'categories': [{'measurements': [{'value': '6.25', 'spread': '9.345', 'groupId': 'OG000'}, {'value': '4.11', 'spread': '10.999', 'groupId': 'OG001'}]}]}, {'title': 'Week 130', 'categories': [{'measurements': [{'value': '6.05', 'spread': '9.610', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '9.680', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'categories': [{'measurements': [{'value': '5.72', 'spread': '8.115', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '9.034', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156', 'description': "Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56.\n\nON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.", 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Perampanel (Placebo During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}, {'id': 'FG001', 'title': 'Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '136'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Study termination by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '44'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Perampanel (Placebo During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}, {'id': 'BG001', 'title': 'Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Safety population', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The participant flow information was collected from all participants who entered the study. Baseline information was collected only for the safety population (all subjects who received at least 1 dose of perampanel in this study and at least 1 dose of study medication during the double-blind phase of the core study).', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Race', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'whyStopped': "Due to termination of clinical program for Parkinson's Disease", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2012-08-14', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-25', 'studyFirstSubmitDate': '2012-07-03', 'dispFirstSubmitQcDate': '2012-08-14', 'resultsFirstSubmitDate': '2012-10-23', 'studyFirstSubmitQcDate': '2012-07-05', 'dispFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-02', 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study', 'timeFrame': 'Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156', 'description': 'OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study', 'timeFrame': 'Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156', 'description': 'ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.'}, {'measure': 'Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study', 'timeFrame': 'Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156', 'description': "Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56.\n\nON state is when medication is providing benefits with regard to stiffness, slowness, and tremor."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': 'A 48-month open label multi-centered extension study to evaluate the long-term safety, tolerability and efficacy of E2007 in patients with Parkinson\'s Disease with "wearing off" motor fluctuations and "on" period Dyskinesias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients enrolled in Study E2007-E044-204 and who either completed 12 weeks of study drug treatment or who withdrew from the study due to lack of efficacy.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g. abstinence, IUD-intrauterine device, or barrier method plus hormonal method). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential.\n* Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception. These patients and their partners must also be willing to remain using reliable contraception for the duration of the study.\n* Patients with a past or present history of drug or alcohol abuse.\n* Patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking anti-depressant medication, however the dose must have been kept stable for at least 8 weeks prior to baseline visit.\n* Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.\n* Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).\n* Patients with current or prior treatment (within 4 weeks prior to the Baseline visit) with medication known to induce the enzyme cytochrome P450 3A4 including but not limited to; carbamazepine; dexamethasone; ethosuximide; phenobarbital; phenytoin; primidone; rifabutin; rifampicin; and St John's Wort.\n* Current or prior treatment (within 4 weeks prior to baseline visit) with methyldopa, budipine, reserpine or intermittent use of liquid forms of levodopa or as needed (prn) apo-morphine.\n* Patients with previous stereotactic surgery (e.g. pallidotomy) for Parkinson's disease or who are likely to undergo surgery for Parkinson's disease while participating in this study.\n* Patients receiving deep brain stimulation (DBS) or who are likely to undergo DBS for Parkinson's disease while participating in the extension study.\n* Patients with clinically significant cognitive impairment (mini-mental state examination (MMSE) \\<24 and /or fulfilling diagnostic and statistical manual of mental disorders (DSM IV) criteria for dementia due to Parkinson's disease).\n* Patients with conditions affecting the peripheral or central sensory system."}, 'identificationModule': {'nctId': 'NCT01634360', 'briefTitle': "Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson\'s Disease With "Wearing Off" Motor Fluctuations and "on" Period Dyskinesias', 'orgStudyIdInfo': {'id': 'E2007-E044-205'}, 'secondaryIdInfos': [{'id': '2004-000361-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perampanel (1-4 mg)', 'description': 'Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204), and dosed placebo or perampanel. Subjects started this open-label extension study on perampanel 1 mg once daily for two weeks, followed by 2 mg once daily for two weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.', 'interventionNames': ['Drug: Perampanel']}], 'interventions': [{'name': 'Perampanel', 'type': 'DRUG', 'otherNames': ['E2007'], 'description': '1mg once daily for two weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.', 'armGroupLabels': ['Perampanel (1-4 mg)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}