Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-04-02 @ 5:02 PM
Study NCT ID:
NCT00772603
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2008-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078330', 'term': 'Oxcarbazepine'}], 'ancestors': [{'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sschwabe@supernus.com', 'phone': '301-838-2500', 'title': 'Stefan Schwabe, M.D., Ph.D., Chief Medical Officer', 'phoneExt': '2527', 'organization': 'Supernus Pharmaceuticals, Inc'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All randomized subjects who took at least one dose of study drug.', 'description': 'Safety was assessed using adverse events (AEs), clinical laboratory results, vital signs, physical and neurological examinations, and electrocardiograms (ECGs).', 'eventGroups': [{'id': 'EG000', 'title': '2400mg/Day SPN-804', 'description': '2400mg total daily dose of SPN-804O once a day (QD), given as four 600mg tablets', 'otherNumAtRisk': 123, 'otherNumAffected': 69, 'seriousNumAtRisk': 123, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': '1200mg/Day SPN-804', 'description': '1200mg total daily dose of SPN-804O QD, given as two 600mg tablets and two identical placebo tablets.', 'otherNumAtRisk': 122, 'otherNumAffected': 57, 'seriousNumAtRisk': 122, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Placebo', 'description': 'placebo QD, given as four placebo tablets', 'otherNumAtRisk': 121, 'otherNumAffected': 55, 'seriousNumAtRisk': 121, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 60, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Balance Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skull fractured, base', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyponatreamia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pituitary tumor, benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsions/complex partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post-ictal state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pityriasis rosea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stevens-Johnson Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PCH(T), ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2400mg/Day SPN-804', 'description': '2400mg SPN-804 once daily'}, {'id': 'OG001', 'title': '1200mg/Day SPN-804', 'description': '1200mg SPN-804 once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-42.90', 'spread': '53.11', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '212.8'}, {'value': '-38.20', 'spread': '69.84', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '556.1'}, {'value': '-28.70', 'spread': '67.34', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '333.6'}]}]}], 'analyses': [{'pValue': '=0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.30', 'ciLowerLimit': '-30.40', 'ciUpperLimit': '-5.80', 'pValueComment': 'P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.', 'groupDescription': 'A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '=0.078', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.30', 'ciLowerLimit': '-22.30', 'ciUpperLimit': '1.20', 'pValueComment': 'P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.', 'groupDescription': 'A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline', 'description': 'Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH\\[T\\]), Intent-to-Treat population.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.'}, {'type': 'SECONDARY', 'title': 'PCH(M)- ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2400mg/Day SPN-804', 'description': '2400mg SPN-804O once daily'}, {'id': 'OG001', 'title': '1200mg/Day SPN-804', 'description': '1200mg SPN-804O given once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo given once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-49.15', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '158'}, {'value': '-35.30', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '690.5'}, {'value': '-32.90', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '212.6'}]}]}], 'analyses': [{'pValue': '=0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.00', 'ciLowerLimit': '-33.00', 'ciUpperLimit': '-6.30', 'pValueComment': 'P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.', 'groupDescription': 'A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '=0.589', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.30', 'ciLowerLimit': '-16.20', 'ciUpperLimit': '9.70', 'pValueComment': 'P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.', 'groupDescription': 'A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Change at 12 weeks (Maintenance Period) compared to Baseline', 'description': 'Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH\\[M\\]), Intent-to-Treat population', 'unitOfMeasure': 'percentage of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.'}, {'type': 'SECONDARY', 'title': 'Responder Rate, ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2400mg/Day SPN-804', 'description': '2400mg SPN-804O once daily'}, {'id': 'OG001', 'title': '1200mg/Day SPN-804', 'description': '1200mg SPN-804O given once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo given once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.018', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.983', 'ciLowerLimit': '1.126', 'ciUpperLimit': '3.494', 'groupDescription': 'The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '=0.075', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.670', 'ciLowerLimit': '0.950', 'ciUpperLimit': '2.937', 'groupDescription': 'The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)', 'description': 'Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.'}, {'type': 'SECONDARY', 'title': 'Seizure-Free Rates, ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2400mg/Day SPN-804', 'description': '2400mg SPN-804O once daily'}, {'id': 'OG001', 'title': '1200mg/Day SPN-804', 'description': '1200mg SPN-804O given once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo given once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.013', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': "Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '=0.528', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)', 'description': 'Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.'}, {'type': 'SECONDARY', 'title': 'Seizure Free Rate, ITT, (M)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2400mg/Day SPN-804', 'description': '2400mg SPN-804O once daily'}, {'id': 'OG001', 'title': '1200mg/Day SPN-804', 'description': '1200mg SPN-804O given once daily'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo given once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.008', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': "Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '=0.0546', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': "Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of 12 weeks (Maintenance Period)', 'description': 'Percent of patients seizure-free during Maintenance, Intent-to-Treat population', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2400mg/Day SPN-804', 'description': '2400mg of SPN-804O once daily'}, {'id': 'FG001', 'title': '1200mg/Day SPN-804', 'description': '1200mg SPN-804O once daily'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Subject Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Adult patients with refractory partial onset epilepsy were recruited from December 2009 to March 2011 at clinical sites in 8 countries.', 'preAssignmentDetails': 'Patients had at least three partial seizures per 28 days during an 8 week Baseline Period. Subjects were receiving treatment with one to three antiepileptic drugs and were on stable treatment for a minimum of 4 weeks. Subjects with a diagnosis other than partial epilepsy were excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '2400mg/Day SPN-804', 'description': '2400mg SPN-804O once daily'}, {'id': 'BG001', 'title': '1200mg/Day SPN-804', 'description': '1200mg SPN-804O given once daily'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo given once daily.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '11.58', 'groupId': 'BG000'}, {'value': '39.1', 'spread': '11.51', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '12.49', 'groupId': 'BG002'}, {'value': '38.9', 'spread': '11.84', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-23', 'studyFirstSubmitDate': '2008-10-10', 'resultsFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2008-10-10', 'lastUpdatePostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-23', 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCH(T), ITT', 'timeFrame': 'Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline', 'description': 'Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH\\[T\\]), Intent-to-Treat population.'}], 'secondaryOutcomes': [{'measure': 'PCH(M)- ITT', 'timeFrame': 'Change at 12 weeks (Maintenance Period) compared to Baseline', 'description': 'Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH\\[M\\]), Intent-to-Treat population'}, {'measure': 'Responder Rate, ITT', 'timeFrame': 'At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)', 'description': 'Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population'}, {'measure': 'Seizure-Free Rates, ITT', 'timeFrame': 'At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)', 'description': 'Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population'}, {'measure': 'Seizure Free Rate, ITT, (M)', 'timeFrame': 'At the end of 12 weeks (Maintenance Period)', 'description': 'Percent of patients seizure-free during Maintenance, Intent-to-Treat population'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Partial onset epilepsy', 'Partial onset seizures'], 'conditions': ['Epilepsies, Partial']}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures', 'detailedDescription': 'Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable of complying with the study procedures.\n* Able to provide written informed consent\n* Male or female aged 18 to 65 years, inclusive.\n* Diagnosis of partial onset seizures\n* Minimum of three seizures per 28 days\n* Receiving treatment with 1-3 AEDs\n* Refractory to at least one AED\n* No progressive neurological conditions by recent MRI/CT\n* Adequate birth control in women of child-bearing potential\n\nExclusion Criteria:\n\n* Refractory to OXC for reasons of efficacy\n* Recent status epilepticus\n* Recent non-epileptic seizures\n* Current diagnosis of major depression\n* Recent suicidal plan or intent or more than one attempt\n* Current use of oxcarbazepine, felbamate for \\< 18 months, phenytoin with levels \\>15mcg/mL or frequent need for rescue benzodiazepines\n* Current use of sodium-lowering non-seizure medications.\n* Clinically significant hepatic, renal, or cardiovascular function\n* History of recent substance abuse\n* Females who are pregnant or lactating.\n* Hypersensitivity to OXC or related drugs\n* Difficulty swallowing study medication'}, 'identificationModule': {'nctId': 'NCT00772603', 'acronym': 'PROSPER1', 'briefTitle': 'Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supernus Pharmaceuticals, Inc.'}, 'officialTitle': 'Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures', 'orgStudyIdInfo': {'id': '804P301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo - four identical tablets taken orally once daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2400 mg SPN-804', 'description': '2400mg OXC XR taken orally once daily as four identical tablets', 'interventionNames': ['Drug: 2400mg SPN-804']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1200mg SPN-804', 'description': '1200mg OXC XR taken orally once daily as four identical tablets', 'interventionNames': ['Drug: 1200mg SPN-804']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sham treatment'], 'description': 'Non-active tablet identical to study drug tablets', 'armGroupLabels': ['Placebo']}, {'name': '2400mg SPN-804', 'type': 'DRUG', 'otherNames': ['Oxcarbazepine extended-release', 'Oxtellar XR', 'Oxtellar'], 'description': 'tablets containing 600mg OXC XR, identical to non-active tablets', 'armGroupLabels': ['2400 mg SPN-804']}, {'name': '1200mg SPN-804', 'type': 'DRUG', 'otherNames': ['Oxcarbazepine extended-release', 'Oxtellar XR', 'Oxtellar'], 'description': 'two active tablets and two non-active tablets, all identical', 'armGroupLabels': ['1200mg SPN-804']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Northport', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.22901, 'lon': -87.57723}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Riverside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'city': 'West Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.0462, 'lon': -118.43068}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Baytown', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.7355, 'lon': -94.97743}}, {'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'city': 'Blagoevgrad', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.01457, 'lon': 23.09804}}, {'city': 'Pleven', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Rousse', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Varna', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'city': 'Dubrovnik', 'country': 'Croatia', 'geoPoint': {'lat': 42.64125, 'lon': 18.10909}}, {'city': 'Rijeka', 'country': 'Croatia', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Zadar', 'country': 'Croatia', 'geoPoint': {'lat': 44.11578, 'lon': 15.22514}}, {'city': 'Zagreb', 'country': 'Croatia', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Aguascalientes', 'state': 'Aguascalientes', 'country': 'Mexico', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'city': 'Chihuahua City', 'state': 'Chihuahua', 'country': 'Mexico', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'city': 'Ciudad Juárez', 'state': 'Chihuahua', 'country': 'Mexico', 'geoPoint': {'lat': 31.72024, 'lon': -106.46084}}, {'city': 'Durango', 'state': 'Durango', 'country': 'Mexico', 'geoPoint': {'lat': 24.02032, 'lon': -104.65756}}, {'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Zapopan', 'state': 'Jalisco', 'country': 'Mexico', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'Puebla City', 'state': 'Puebla', 'country': 'Mexico', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}, {'city': 'San Luis Potosí City', 'state': 'San Luis Potosí', 'country': 'Mexico', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'city': 'Toluca', 'state': 'State of Mexico', 'country': 'Mexico', 'geoPoint': {'lat': 19.28786, 'lon': -99.65324}}, {'city': 'Giżycko', 'country': 'Poland', 'geoPoint': {'lat': 54.03811, 'lon': 21.76441}}, {'city': 'Gmina Końskie', 'country': 'Poland', 'geoPoint': {'lat': 51.19166, 'lon': 20.40607}}, {'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wilkowice', 'country': 'Poland', 'geoPoint': {'lat': 49.76282, 'lon': 19.08973}}, {'city': 'Zabrze', 'country': 'Poland', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Campulung Muscel', 'country': 'Romania', 'geoPoint': {'lat': 45.26667, 'lon': 25.05}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Craiova', 'country': 'Romania', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Saint Petersburg', 'state': 'Sestroretsk', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': "Kazan'", 'country': 'Russia', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Kirov', 'country': 'Russia', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'city': 'Kursk', 'country': 'Russia', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Nizhny Novgorod', 'country': 'Russia', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'city': 'Novosibirsk', 'country': 'Russia', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Pyatigorsk', 'country': 'Russia', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Smolensk', 'country': 'Russia', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'city': 'Yaroslavl', 'country': 'Russia', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}], 'overallOfficials': [{'name': 'Janet K Johnson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Supernus Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Supernus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}