Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-29 @ 1:11 PM
Study NCT ID:
NCT01710657
Status:
COMPLETED
Last Update Posted:
2017-08-25
First Post:
2012-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078334', 'term': 'Lacosamide'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493 (UCB)', 'title': 'UCB Clinical Trial Call Center', 'organization': 'UCB'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected from Baseline to the end of the study (up to Week 19).', 'description': 'Treatment Emergent Adverse Events (TEAEs) refer to the Safety Set (SS). The SS includes all randomized subjects who took at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching Placebo for 16 weeks.\n\nPlacebo: Matching oral Placebo tablets twice daily for 16 weeks.', 'otherNumAtRisk': 184, 'otherNumAffected': 77, 'seriousNumAtRisk': 184, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Lacosamide 200 mg/Day', 'description': 'Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use', 'otherNumAtRisk': 183, 'otherNumAffected': 87, 'seriousNumAtRisk': 183, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Lacosamide 400 mg/Day', 'description': 'Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use', 'otherNumAtRisk': 180, 'otherNumAffected': 112, 'seriousNumAtRisk': 180, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 41, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 40, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 36, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 28, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 57, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 118, 'numAffected': 63}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 32, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Epileptic psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo for 16 weeks.\n\nPlacebo: Matching oral Placebo tablets twice daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Lacosamide 200 mg/Day', 'description': 'Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}, {'id': 'OG002', 'title': 'Lacosamide 400 mg/Day', 'description': 'Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.22', 'groupId': 'OG000', 'lowerLimit': '-93.0', 'upperLimit': '39.8'}, {'value': '-3.33', 'groupId': 'OG001', 'lowerLimit': '-754.3', 'upperLimit': '165.2'}, {'value': '-4.50', 'groupId': 'OG002', 'lowerLimit': '-97.5', 'upperLimit': '28.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': '% Reduction over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.6', 'ciLowerLimit': '30.5', 'ciUpperLimit': '47.6', 'pValueComment': 'Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.', 'groupDescription': 'To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.\n\nIf the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': '% Reduction over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.4', 'ciLowerLimit': '18.7', 'ciUpperLimit': '38.7', 'pValueComment': 'Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.', 'groupDescription': 'To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.\n\nIf the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)', 'description': 'Partial-onset seizure (POS) frequency per 28 days was calculated as:\n\nPOS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.\n\nA negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.', 'unitOfMeasure': 'Seizures per 28 days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo for 16 weeks.\n\nPlacebo: Matching oral Placebo tablets twice daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Lacosamide 200 mg/Day', 'description': 'Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}, {'id': 'OG002', 'title': 'Lacosamide 400 mg/Day', 'description': 'Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo for 16 weeks.\n\nPlacebo: Matching oral Placebo tablets twice daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Lacosamide 200 mg/Day', 'description': 'Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}, {'id': 'OG002', 'title': 'Lacosamide 400 mg/Day', 'description': 'Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.10', 'groupId': 'OG000', 'lowerLimit': '-97.6', 'upperLimit': '233.5'}, {'value': '-36.75', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '185.5'}, {'value': '-48.78', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '346.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)', 'description': 'Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching Placebo for 16 weeks.\n\nPlacebo: Matching oral Placebo tablets twice daily for 16 weeks.'}, {'id': 'OG001', 'title': 'Lacosamide 200 mg/Day', 'description': 'Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}, {'id': 'OG002', 'title': 'Lacosamide 400 mg/Day', 'description': 'Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.10', 'groupId': 'OG000', 'lowerLimit': '-102.4', 'upperLimit': '102.5'}, {'value': '-3.39', 'groupId': 'OG001', 'lowerLimit': '-670.0', 'upperLimit': '138.9'}, {'value': '-4.00', 'groupId': 'OG002', 'lowerLimit': '-92.4', 'upperLimit': '34.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)', 'description': 'Partial-onset seizure (POS) frequency per 28 days was calculated as:\n\nPOS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.\n\nA negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.', 'unitOfMeasure': 'Seizures per 28 days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching Placebo for 16 weeks.\n\nPlacebo: Matching oral Placebo tablets twice daily for 16 weeks.'}, {'id': 'FG001', 'title': 'Lacosamide 200 mg/Day', 'description': 'Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}, {'id': 'FG002', 'title': 'Lacosamide 400 mg/Day', 'description': 'Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '183'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'Titration Period (4 Weeks)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '183'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'Maintenance Period (12 Weeks)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '171'}, {'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 676 subjects with uncontrolled partial-onset seizures (of the 676 subjects, the number of Chinese subjects and Japanese subjects was planned to be 507 and 169, respectively) was planned to be screened and 540 subjects were planned to be enrolled in all regions of Japan and China.', 'preAssignmentDetails': 'Overall, 692 subjects were screened and 548 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 547 subjects were included in the Safety Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '547', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matching Placebo for 16 weeks.\n\nPlacebo: Matching oral Placebo tablets twice daily for 16 weeks.'}, {'id': 'BG001', 'title': 'Lacosamide 200 mg/Day', 'description': 'Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}, {'id': 'BG002', 'title': 'Lacosamide 400 mg/Day', 'description': 'Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.\n\nLacosamide 50 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use\n\nLacosamide 100 mg: - Active Substance: Lacosamide\n\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '491', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '33.2', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '32.3', 'spread': '11.9', 'groupId': 'BG002'}, {'value': '32.4', 'spread': '12.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '247', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '547', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Chinese', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '405', 'groupId': 'BG003'}]}]}, {'title': 'Japanese', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The Baseline Characteristics refer to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 548}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-28', 'studyFirstSubmitDate': '2012-10-17', 'resultsFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2012-10-17', 'lastUpdatePostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-22', 'studyFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period', 'timeFrame': '8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)', 'description': 'Partial-onset seizure (POS) frequency per 28 days was calculated as:\n\nPOS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.\n\nA negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.'}], 'secondaryOutcomes': [{'measure': 'The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)', 'timeFrame': '8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)'}, {'measure': 'Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period', 'timeFrame': '8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)', 'description': 'Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.'}, {'measure': 'Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)', 'timeFrame': '8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)', 'description': 'Partial-onset seizure (POS) frequency per 28 days was calculated as:\n\nPOS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.\n\nA negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lacosamide', 'Epilepsy', 'Partial Onset Seizures'], 'conditions': ['Epilepsy', 'Partial Onset Seizures']}, 'referencesModule': {'references': [{'pmid': '23859801', 'type': 'RESULT', 'citation': 'Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981)\n* Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion\n* Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period\n* Minimum Body Weight of 40 kg\n\nExclusion Criteria:\n\n* Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening\n* Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures\n* Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1\n* Subject has a history of Primary Generalized Seizures\n* Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1\n* Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1\n* Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol'}, 'identificationModule': {'nctId': 'NCT01710657', 'briefTitle': 'A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization', 'orgStudyIdInfo': {'id': 'EP0008'}, 'secondaryIdInfos': [{'id': '2014-003622-41', 'type': 'EUDRACT_NUMBER'}, {'id': 'JapicCTI-121988', 'type': 'REGISTRY', 'domain': 'JAPIC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo for 16 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Lacosamide 200 mg/day', 'description': 'Lacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.', 'interventionNames': ['Drug: Lacosamide 50 mg', 'Drug: Lacosamide 100 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Lacosamide 400 mg/day', 'description': 'Lacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.', 'interventionNames': ['Drug: Lacosamide 50 mg', 'Drug: Lacosamide 100 mg']}], 'interventions': [{'name': 'Lacosamide 50 mg', 'type': 'DRUG', 'otherNames': ['Vimpat'], 'description': '* Active Substance: Lacosamide\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 50 mg\n* Route of Administration: Oral use', 'armGroupLabels': ['Lacosamide 200 mg/day', 'Lacosamide 400 mg/day']}, {'name': 'Lacosamide 100 mg', 'type': 'DRUG', 'otherNames': ['Vimpat'], 'description': '* Active Substance: Lacosamide\n* Pharmaceutical Form: Film-coated tablet\n* Concentration: 100 mg\n* Route of Administration: Oral use', 'armGroupLabels': ['Lacosamide 200 mg/day', 'Lacosamide 400 mg/day']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching oral Placebo tablets twice daily for 16 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': '86026', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': '86027', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': '86015', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Chengdu', 'country': 'China', 'facility': '86005', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'country': 'China', 'facility': '86032', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqing', 'country': 'China', 'facility': '86006', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Dalian', 'country': 'China', 'facility': '86031', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Guanghzou', 'country': 'China', 'facility': '86009'}, {'city': 'Guangzhou', 'country': 'China', 'facility': '86007', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'country': 'China', 'facility': '86008', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'country': 'China', 'facility': '86013', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'country': 'China', 'facility': '86016', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'country': 'China', 'facility': '86014', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Harbin', 'country': 'China', 'facility': '86010', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Jinan', 'country': 'China', 'facility': '86019', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Kunming', 'country': 'China', 'facility': '86004', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Nanchang', 'country': 'China', 'facility': '86011', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanchang', 'country': 'China', 'facility': '86012', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanjing', 'country': 'China', 'facility': '86028', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Qingdao', 'country': 'China', 'facility': '86003', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shanghai', 'country': 'China', 'facility': '86001', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': '86023', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': '86025', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'country': 'China', 'facility': '86021', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shijiazhuang', 'country': 'China', 'facility': '86020', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Suzhou', 'country': 'China', 'facility': '86022', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Taiyuan', 'country': 'China', 'facility': '86002', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Wuhan', 'country': 'China', 'facility': '86018', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'country': 'China', 'facility': '86024', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': "Xi'an", 'country': 'China', 'facility': '86017', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Xiamen', 'country': 'China', 'facility': '86029', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Asaka', 'country': 'Japan', 'facility': '81056', 'geoPoint': {'lat': 35.80472, 'lon': 139.60194}}, {'city': 'Fujisawa', 'country': 'Japan', 'facility': '81030', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': '81013', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': '81054', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hachinohe', 'country': 'Japan', 'facility': '81057', 'geoPoint': {'lat': 40.5, 'lon': 141.5}}, {'city': 'Hakodate', 'country': 'Japan', 'facility': '81008', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'city': 'Hamamatsu', 'country': 'Japan', 'facility': '81027', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'city': 'Himeji', 'country': 'Japan', 'facility': '81004', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': '81018', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Iwanuma', 'country': 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'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UCB Japan Co. 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