Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-01-02 @ 6:44 AM
Study NCT ID:
NCT00350103
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2006-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine 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': {'email': 'UCBCares@ucb.com', 'phone': '001 844 599 2273', 'title': 'UCB', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline until the end of the trial (up to Week 18)', 'description': 'Adverse Events refer to the Safety Set, consisting of all randomized subjects who took at least one dose of study medication. It was pre-specified in the Statistical Analysis Plan that AEs will be summarized and disclosed for placebo and LCM 400 mg/day (pooled) for all participants, who took at least one dose of medication (Safety Set). AEs were planned to be collected and summarized irrespective of dosing strategy.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.', 'otherNumAtRisk': 179, 'deathsNumAtRisk': 179, 'otherNumAffected': 21, 'seriousNumAtRisk': 179, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Lacosamide Pooled FT and ST', 'description': 'Subjects received LCM as Fast Titration (FT) or Standard Titration (ST).', 'otherNumAtRisk': 370, 'deathsNumAtRisk': 370, 'otherNumAffected': 82, 'seriousNumAtRisk': 370, 'deathsNumAffected': 0, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 21}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Jejunitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Electrocardiogram PR prolongation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Toe deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastrinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebellar syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 370, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0410', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '-0.02', 'estimateComment': 'Estimated value is the difference of Least Square Means.', 'groupDescription': 'Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '=0.2902', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.20', 'estimateComment': 'Estimated value is the difference of Least Square Means.', 'groupDescription': 'Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Last 4 weeks of Maintenance Phase, compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Time to Sustainable Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'comment': 'Upper confidence limits are not provided for the 95% CI of the median time to sustainable pain relief when there is no observed sustainable pain relief time for which the upper bound of the confidence interval for the Kaplan-Meier estimate is less than 0.5.', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': 'NA'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '35.0'}, {'value': '10.0', 'comment': 'Upper confidence limits are not provided for the 95% CI of the median time to sustainable pain relief when there is no observed sustainable pain relief time for which the upper bound of the confidence interval for the Kaplan-Meier estimate is less than 0.5.', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of trial medication intake (Week 0) up to the last 4 weeks of the Maintenance Phase', 'description': 'Time to sustainable pain relief was defined as the time from Baseline to the first day on which there was a ≥1-point improvement over Baseline in the Likert pain score for those subjects for whom there was also ≥30% reduction in average daily pain score over the last 28 days of the Maintenance Phase as compared to Baseline.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With >= 30% or >= 2-point Reduction of with-in Subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of the Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000'}, {'value': '56.4', 'groupId': 'OG001'}, {'value': '55.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline week, last 4 weeks of the Maintenance Phase', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '1.06', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline week, Visit 3', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline week, Visit 4', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.87', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '1.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline week, Visit 5', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '1.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline week, Visit 6', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '1.98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline week, Visit 7', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.07', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '2.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline week, Visit 8', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to the Titration Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Titration Phase (4 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to the Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '1.98', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '1.92', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maintenance Phase (12 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to the Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '1.72', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Phase (16 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.08', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last 4 weeks of Maintenance Phase, compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's average daily pain scores at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 3', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.69', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 4', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.04', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '2.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 5', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '2.28', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '2.26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 6', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.22', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '2.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 7', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '2.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 8', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.62', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.67', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Titration Phase (4 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.22', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maintenance Phase (12 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '2.04', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Phase (16 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms. A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to the Last 4 Weeks of Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.24', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '2.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last 4 weeks of Maintenance Phase, compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's sleep at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '1.40', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 3', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 4', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '2.11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 5', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '2.12', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '2.28', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 6', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '2.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 7', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.15', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.42', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Week, Visit 8', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.72', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Titration Phase (4 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '2.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maintenance Phase (12 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '2.06', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Phase (16 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': "Within-subject Change From the Baseline Week to the Last 4 Weeks of the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '2.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last 4 weeks of Maintenance Phase, compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for subject's pain interference with subject's general activity at the respective are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Percentage of Days of Rescue Medication Use During the Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '20.27', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '20.28', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '23.67', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the Treatment Phase (up to 16 weeks)', 'description': 'Percentage of days of rescue medication use was the number of days in the visit/trial phase with rescue medication use divided by the total number of days in the visit/trial phase times 100.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with available data for rescue medication use are included in the analysis.'}, {'type': 'SECONDARY', 'title': "Within-subject Change From Baseline to Visit 8 in Subject's Quality of Life", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide Pooled FT and ST', 'description': 'Subjects received LCM as Fast Titration (FT) or Standard Titration (ST).'}], 'classes': [{'title': 'Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '16.30', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '18.85', 'groupId': 'OG001'}]}]}, {'title': 'Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.3', 'spread': '37.80', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '39.33', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.4', 'spread': '20.51', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '19.99', 'groupId': 'OG001'}]}]}, {'title': 'General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '15.09', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '15.39', 'groupId': 'OG001'}]}]}, {'title': 'Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '16.12', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '17.94', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '23.05', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '22.37', 'groupId': 'OG001'}]}]}, {'title': 'Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '44.42', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '47.28', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '16.97', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '18.60', 'groupId': 'OG001'}]}]}, {'title': 'PCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '6.61', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '6.99', 'groupId': 'OG001'}]}]}, {'title': 'MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '10.06', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '10.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Visit 8', 'description': 'Quality of life was analyzed using the Short Form-36 (SF-36) Health Survey. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 contribute to the physical component Summary (PCS) score. Items 5-8 contribute to the mental component summary (MCS) score. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive change value indicates improvement from baseline. As pre-specified in SAP, values were planned to be summarized and disclosed by placebo and LCM 400 mg/day (pooled) groups.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "A total of 177 subjects treated with Placebo and 365 subjects treated with lacosamide were initially included in the Full Analysis Set. Only subjects with available data for change from Baseline to Visit 8 in the sub-scores of subject's quality of life are included in the analysis. Number of subjects analyzed is given separately per sub-score."}, {'type': 'SECONDARY', 'title': "Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 8", 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide Pooled FT and ST', 'description': 'Subjects received LCM as Fast Titration (FT) or Standard Titration (ST).'}], 'classes': [{'title': 'Much worse', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Moderately worse', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Mildly worse', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Mildly better', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Moderately better', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}]}]}, {'title': 'Much better', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '21.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 8', 'description': 'The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better. As pre-specified in SAP, values were planned to be summarized and disclosed by placebo and LCM 400 mg/day (pooled) reporting groups.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Only subjects with available data for Patient's Global Impression of Change in Pain are included in the analysis."}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Categorized Satisfaction With Medications at Visit 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'title': 'Very Satisfied', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '14.0', 'groupId': 'OG001'}, {'value': '15.5', 'groupId': 'OG002'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}]}]}, {'title': 'Neither Satisfied/Dissatisfied', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}, {'value': '23.8', 'groupId': 'OG002'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}]}]}, {'title': 'Very Dissatisfied', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Not Done', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 8', 'description': 'Categories of satisfaction are as following: very satisfied, satisfied, neither satisfied/dissatisfied, dissatisfied, very dissatisfied, not applicable, not done (no data available).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with available data for satisfaction with medications are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores at Visit 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'OG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'classes': [{'title': 'Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.4', 'spread': '19.30', 'groupId': 'OG000'}, {'value': '-15.2', 'spread': '22.65', 'groupId': 'OG001'}, {'value': '-17.1', 'spread': '23.97', 'groupId': 'OG002'}]}]}, {'title': 'Sleep Somnolence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '16.25', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '19.69', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '20.41', 'groupId': 'OG002'}]}]}, {'title': 'Snoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '27.33', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '25.13', 'groupId': 'OG001'}, {'value': '-6.7', 'spread': '27.25', 'groupId': 'OG002'}]}]}, {'title': 'SoB/ Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': '23.32', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '26.75', 'groupId': 'OG001'}, {'value': '-7.5', 'spread': '24.76', 'groupId': 'OG002'}]}]}, {'title': 'Sleep Adequacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '26.11', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '26.37', 'groupId': 'OG001'}, {'value': '15.1', 'spread': '30.28', 'groupId': 'OG002'}]}]}, {'title': 'SPI I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'spread': '15.15', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '17.39', 'groupId': 'OG001'}, {'value': '-12.2', 'spread': '19.58', 'groupId': 'OG002'}]}]}, {'title': 'SPI II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.6', 'spread': '14.18', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '16.66', 'groupId': 'OG001'}, {'value': '-13.1', 'spread': '19.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Visit 8', 'description': "The MOS Sleep scale is used to assess the subject's quality of sleep. The scale consists of 12 individual items categorized into two sleep problems indices (SPI I/II) and 5 subscales: sleep disturbance, sleep somnolence, snoring, short of breath (SoB) or headache, sleep adequacy. Scores range from 0 to 100. Sleep adequacy scale: High values indicate a high quality of sleep. A positive change indicates improvement in quality of sleep. All other Sleep Scales: Low values indicate a high quality of sleep. A negative change indicates improvement in quality of sleep.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '177 subjects treated with Placebo, 188 subjects treated with Lacosamide FT and 177 subjects treated with Lacosamide ST were initially included in the FAS. Only subjects with available data for change from Baseline to Visit 8 in MOS sleep scale scores are included in the analysis. Number of subjects analyzed is given separately per sub-score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'FG001', 'title': 'Lacosamide Fast Titration (FT)', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'FG002', 'title': 'Lacosamide Standard Titration (ST)', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '190'}, {'groupId': 'FG002', 'numSubjects': '182'}]}, {'type': 'Entered Titration Phase', 'comment': 'Received at least 1 dose of study medication (Safety Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '189'}, {'groupId': 'FG002', 'numSubjects': '181'}]}, {'type': 'Completed Titration Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '164'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'Entered Maintenance Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '164'}]}, {'type': 'Completed Maintenance Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Unsatisfactory Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Investigator´s decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Exclusion criteria met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Patient relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Need for prohibited medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Patient stopped feeling pain', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'PR greater than 250ms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Wrong calculation of QT interval', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Sponsor mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Randomization mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Sponsor´s decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost, Reason unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study started to enroll patients in June 2006 and concluded in June 2007.', 'preAssignmentDetails': 'Participant Flow refers to the Randomized Set. The 16-week Treatment Phase consisted of 4-week Titration Phase and 12-week Maintenance Phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}, {'value': '551', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'BG001', 'title': 'Lacosamide FT', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'BG002', 'title': 'Lacosamide ST', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.'}, {'id': 'BG003', 'title': 'Total Title'}], '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': '142', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '423', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '9.45', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '9.46', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '10.14', 'groupId': 'BG002'}, {'value': '57.3', 'spread': '9.68', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to the Randomized Set which included all enrolled participants who were randomized to a specific treatment arm.'}}, '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': 551}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2007-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2006-07-06', 'resultsFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2006-07-06', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-20', 'studyFirstPostDateStruct': {'date': '2006-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase', 'timeFrame': 'Last 4 weeks of Maintenance Phase, compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week."}], 'secondaryOutcomes': [{'measure': 'Time to Sustainable Pain Relief', 'timeFrame': 'From start of trial medication intake (Week 0) up to the last 4 weeks of the Maintenance Phase', 'description': 'Time to sustainable pain relief was defined as the time from Baseline to the first day on which there was a ≥1-point improvement over Baseline in the Likert pain score for those subjects for whom there was also ≥30% reduction in average daily pain score over the last 28 days of the Maintenance Phase as compared to Baseline.'}, {'measure': 'Percentage of Subjects With >= 30% or >= 2-point Reduction of with-in Subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of the Maintenance Phase', 'timeFrame': 'Baseline week, last 4 weeks of the Maintenance Phase', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3', 'timeFrame': 'Baseline week, Visit 3', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 4', 'timeFrame': 'Baseline week, Visit 4', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 5', 'timeFrame': 'Baseline week, Visit 5', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 6', 'timeFrame': 'Baseline week, Visit 6', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 7', 'timeFrame': 'Baseline week, Visit 7', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 8', 'timeFrame': 'Baseline week, Visit 8', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to the Titration Phase', 'timeFrame': 'Titration Phase (4 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to the Maintenance Phase', 'timeFrame': 'Maintenance Phase (12 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to the Treatment Phase', 'timeFrame': 'Treatment Phase (16 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week."}, {'measure': 'Within-subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of Maintenance Phase', 'timeFrame': 'Last 4 weeks of Maintenance Phase, compared to the Baseline Week', 'description': "An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week."}, {'measure': "Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Baseline Week, Visit 3', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2."}, {'measure': "Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Baseline Week, Visit 4', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2."}, {'measure': "Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Baseline Week, Visit 5', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2."}, {'measure': "Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Baseline Week, Visit 6', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2."}, {'measure': "Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Baseline Week, Visit 7', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2."}, {'measure': "Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Baseline Week, Visit 8', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2."}, {'measure': "Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Titration Phase (4 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week."}, {'measure': "Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Maintenance Phase (12 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week."}, {'measure': "Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Treatment Phase (16 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms. A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week."}, {'measure': "Within-subject Change From the Baseline Week to the Last 4 Weeks of Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep", 'timeFrame': 'Last 4 weeks of Maintenance Phase, compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week."}, {'measure': "Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Baseline Week, Visit 3', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline."}, {'measure': "Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Baseline Week, Visit 4', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline."}, {'measure': "Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Baseline Week, Visit 5', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline."}, {'measure': "Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Baseline Week, Visit 6', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline."}, {'measure': "Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Baseline Week, Visit 7', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline."}, {'measure': "Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Baseline Week, Visit 8', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline."}, {'measure': "Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Titration Phase (4 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week."}, {'measure': "Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Maintenance Phase (12 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week."}, {'measure': "Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Treatment Phase (16 weeks), compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week."}, {'measure': "Within-subject Change From the Baseline Week to the Last 4 Weeks of the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity", 'timeFrame': 'Last 4 weeks of Maintenance Phase, compared to the Baseline Week', 'description': "An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week."}, {'measure': 'Percentage of Days of Rescue Medication Use During the Treatment Phase', 'timeFrame': 'During the Treatment Phase (up to 16 weeks)', 'description': 'Percentage of days of rescue medication use was the number of days in the visit/trial phase with rescue medication use divided by the total number of days in the visit/trial phase times 100.'}, {'measure': "Within-subject Change From Baseline to Visit 8 in Subject's Quality of Life", 'timeFrame': 'Baseline, Visit 8', 'description': 'Quality of life was analyzed using the Short Form-36 (SF-36) Health Survey. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 contribute to the physical component Summary (PCS) score. Items 5-8 contribute to the mental component summary (MCS) score. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive change value indicates improvement from baseline. As pre-specified in SAP, values were planned to be summarized and disclosed by placebo and LCM 400 mg/day (pooled) groups.'}, {'measure': "Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 8", 'timeFrame': 'Visit 8', 'description': 'The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better. As pre-specified in SAP, values were planned to be summarized and disclosed by placebo and LCM 400 mg/day (pooled) reporting groups.'}, {'measure': 'Percentage of Patients With Categorized Satisfaction With Medications at Visit 8', 'timeFrame': 'Visit 8', 'description': 'Categories of satisfaction are as following: very satisfied, satisfied, neither satisfied/dissatisfied, dissatisfied, very dissatisfied, not applicable, not done (no data available).'}, {'measure': 'Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores at Visit 8', 'timeFrame': 'Baseline, Visit 8', 'description': "The MOS Sleep scale is used to assess the subject's quality of sleep. The scale consists of 12 individual items categorized into two sleep problems indices (SPI I/II) and 5 subscales: sleep disturbance, sleep somnolence, snoring, short of breath (SoB) or headache, sleep adequacy. Scores range from 0 to 100. Sleep adequacy scale: High values indicate a high quality of sleep. A positive change indicates improvement in quality of sleep. All other Sleep Scales: Low values indicate a high quality of sleep. A negative change indicates improvement in quality of sleep."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Painful Diabetic Neuropathy', 'Lacosamide'], 'conditions': ['Painful Diabetic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '29588972', 'type': 'RESULT', 'citation': 'Bainbridge J, De Backer M, Eckhardt K, Tennigkeit F, Bongardt S, Sen D, Werhahn KJ, Shaibani A, Faught E. Safety and tolerability of lacosamide monotherapy in the elderly: A subgroup analysis from lacosamide trials in diabetic neuropathic pain. Epilepsia Open. 2017 Sep 11;2(4):415-423. doi: 10.1002/epi4.12079. eCollection 2017 Dec.'}], 'seeAlsoLinks': [{'url': 'https://www.ucb.com/website/_up/ucb_com_patients/documents/SP874_CSS_20080610.pdf', 'label': 'Clinical Study Summary on UCB.com'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide.\n\nThe maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II).\n\nExclusion Criteria:\n\n* Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial'}, 'identificationModule': {'nctId': 'NCT00350103', 'briefTitle': 'A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Using Two Different Titration Schemes', 'orgStudyIdInfo': {'id': 'SP0874'}, 'secondaryIdInfos': [{'id': '2005-005788-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lacosamide Standard Titration (ST)', 'description': 'Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100 mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.', 'interventionNames': ['Drug: SPM 929']}, {'type': 'EXPERIMENTAL', 'label': 'Lacosamide Fast Titration (FT)', 'description': 'Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.', 'interventionNames': ['Drug: SPM 929']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SPM 929', 'type': 'DRUG', 'otherNames': ['Lacosamide'], 'description': '* Pharmaceutical form: Immediate release film-coated tablets\n* Concentration: 50mg/ 100mg\n* Route of administration: Oral use', 'armGroupLabels': ['Lacosamide Fast Titration (FT)', 'Lacosamide Standard Titration (ST)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '* Pharmaceutical form: Immediate release film-coated tablets\n* Route of administration: Oral use', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Monheim', 'country': 'Germany', 'geoPoint': {'lat': 48.84389, 'lon': 10.85834}}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': '001 844 599 2273 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'SCHWARZ BIOSCIENCES GmbH - Part of UCB Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}