Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00440518
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2007-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078334', 'term': 'Lacosamide'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'Study Director', 'organization': 'UCB Clinical Trial Call Center'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 days but \\<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart', 'otherNumAtRisk': 72, 'otherNumAffected': 30, 'seriousNumAtRisk': 72, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Lacosamide 100mg', 'description': 'Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart', 'otherNumAtRisk': 72, 'otherNumAffected': 36, 'seriousNumAtRisk': 72, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Lacosamide 300mg', 'description': 'Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart', 'otherNumAtRisk': 74, 'otherNumAffected': 33, 'seriousNumAtRisk': 74, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Coronary artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Knee operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG001', 'title': 'Lacosamide 100mg', 'description': 'Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG002', 'title': 'Lacosamide 300mg', 'description': 'Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '2.68', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '2.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Entire 14-week Maintenance Period', 'unitOfMeasure': 'Number of migraine headaches', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG001', 'title': 'Lacosamide 100mg', 'description': 'Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG002', 'title': 'Lacosamide 300mg', 'description': 'Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.82', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '2.44', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, last 4 weeks of the 14-week Maintenance Period', 'unitOfMeasure': 'Number of migraine headaches', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG001', 'title': 'Lacosamide 100mg', 'description': 'Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG002', 'title': 'Lacosamide 300mg', 'description': 'Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Entire 14-week Maintenance Period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG001', 'title': 'Lacosamide 100mg', 'description': 'Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG002', 'title': 'Lacosamide 300mg', 'description': 'Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, last 4 weeks of the 14-week Maintenance Period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG001', 'title': 'Lacosamide 100mg', 'description': 'Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'OG002', 'title': 'Lacosamide 300mg', 'description': 'Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.8', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '8.67', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '8.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, last visit in the 17-week Trial Period', 'description': "Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person's ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject's quality of life.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 71 (Placebo), 70 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects in the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value), 64, 66, and 66 subjects respectively are included in this summary.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'FG001', 'title': 'Lacosamide 100mg', 'description': 'Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'FG002', 'title': 'Lacosamide 300mg', 'description': 'Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}], 'periods': [{'title': 'Randomized /Titration Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Maintenance and Safety Follow-up Periods', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Unsatisfactory Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A multicenter trial with 24 sites with enrolled subjects and 23 sites with randomized subjects from 15 Feb 2007 to 17 Jul 2008.', 'preAssignmentDetails': 'Subjects on stable dose of prophylactic medication entered a 2-week Wash-Out Period followed by a 4-week Baseline Period without any prophylactic medication. Subjects not taking prophylactic medication entered the Baseline Period directly for 6 weeks. Subjects entered a 3-week Titration Period and if completed entered a 14-week Maintenance Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'BG001', 'title': 'Lacosamide 100mg', 'description': 'Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'BG002', 'title': 'Lacosamide 300mg', 'description': 'Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '12.23', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '11.86', 'groupId': 'BG001'}, {'value': '40.2', 'spread': '11.40', 'groupId': 'BG002'}, {'value': '39.9', 'spread': '11.78', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'nctId': 'NCT03559673', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2007-02-23', 'resultsFirstSubmitDate': '2009-08-03', 'studyFirstSubmitQcDate': '2007-02-26', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-08-03', 'studyFirstPostDateStruct': {'date': '2007-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period', 'timeFrame': 'Baseline, Entire 14-week Maintenance Period'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period', 'timeFrame': 'Baseline, last 4 weeks of the 14-week Maintenance Period'}, {'measure': 'Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.', 'timeFrame': 'Baseline, Entire 14-week Maintenance Period'}, {'measure': 'Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.', 'timeFrame': 'Baseline, last 4 weeks of the 14-week Maintenance Period'}, {'measure': 'Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)', 'timeFrame': 'Baseline, last visit in the 17-week Trial Period', 'description': "Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person's ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject's quality of life."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lacosamide', 'migraine prophylaxis', 'Vimpat'], 'conditions': ['Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by mouth, twice a day for up to 18 weeks to prevent migraines.', 'detailedDescription': 'This study is for subjects who have been diagnosed with migraine for at least one year and who are currently taking an effective abortive medication(s).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of migraines headaches for 1 year and well documented 3 month retrospective history of migraines.\n* Experience 2-8 migraines per month but not more than 15 headache days per month. There should be at least 48 hours of freedom between headaches.\n* On effective stable abortive medication(s) for the acute treatment of migraine.\n\nExclusion Criteria:\n\n* Subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial.\n* Use of triptans or ergots for migraine abortive treatment \\> 2-3 days per calendar week 2 months prior to screening.\n* Experience 15 or more headache days per month of any kind 2 months prior to screening.\n* Has another consistent or chronic form of headache.\n* Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring.\n* Pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial.\n* Significant laboratory or electrocardiograms (ECG) abnormalities\n* Significant medical history including cardiovascular abnormalities.'}, 'identificationModule': {'nctId': 'NCT00440518', 'acronym': 'SP906', 'briefTitle': 'A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 100mg/Day and 300mg/Day Lacosamide for Migraine Prophylaxis.', 'orgStudyIdInfo': {'id': 'SP0906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Lacosamide 100mg', 'description': '100mg lacosamide', 'interventionNames': ['Drug: Lacosamide']}, {'type': 'EXPERIMENTAL', 'label': 'Lacosamide 300mg', 'description': '300mg lacosamide', 'interventionNames': ['Drug: Lacosamide']}], 'interventions': [{'name': 'Lacosamide', 'type': 'DRUG', 'otherNames': ['LCM', 'Vimpat'], 'description': 'Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart', 'armGroupLabels': ['Lacosamide 100mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart', 'armGroupLabels': ['Placebo']}, {'name': 'Lacosamide', 'type': 'DRUG', 'otherNames': ['LCM', 'Vimpat'], 'description': 'Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.', 'armGroupLabels': ['Lacosamide 300mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33351', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '30094', 'city': 'Conyers', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.66761, 'lon': -84.01769}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '02481', 'city': 'Wellesley Hills', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.30843, 'lon': -71.27867}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28105', 'city': 'Matthews', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.11681, 'lon': -80.72368}}, {'zip': '44121', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}