Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT01345058
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2011-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Add on Lacosamide Versus High Dose Monotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078334', 'term': 'Lacosamide'}, {'id': 'D000077287', 'term': 'Levetiracetam'}], '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'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JLEE38@BWH.HARVARD.EDU', 'title': 'Jong Woo Lee, MD, PhD', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 Months', 'description': 'All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Lacosamide + Low-Dose Levetiracetam', 'description': 'Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.', 'otherNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group (High-Dose Levetiracetam)', 'description': 'Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \\>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.', 'otherNumAtRisk': 36, 'otherNumAffected': 26, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hair Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability/depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Memory/cognitive difficulties/confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Six Month Seizure Freedom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide + Low-Dose Levetiracetam', 'description': 'Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.'}, {'id': 'OG001', 'title': 'Control Group (High-Dose Levetiracetam)', 'description': 'Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \\>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.65', 'estimateComment': 'Hazard ratio for seizure occurrence for polytherapy relative to monotherapy.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Seizure-Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide + Low-Dose Levetiracetam', 'description': 'Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.'}, {'id': 'OG001', 'title': 'Control Group (High-Dose Levetiracetam)', 'description': 'Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \\>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '118.11', 'spread': '68.59', 'groupId': 'OG000'}, {'value': '114.0', 'spread': '65.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to First Seizure After Therapeutic Dose is Reached', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide + Low-Dose Levetiracetam', 'description': 'Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.'}, {'id': 'OG001', 'title': 'Control Group (High-Dose Levetiracetam)', 'description': 'Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \\>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '162.0', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '180.0'}, {'value': '116.5', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '180.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 Months', 'description': 'Time in days until the first seizure after the therapeutic dose is reached occurs.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Retention Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide + Low-Dose Levetiracetam', 'description': 'Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.'}, {'id': 'OG001', 'title': 'Control Group (High-Dose Levetiracetam)', 'description': 'Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \\>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Retention rate is defined as the percentage of participants who remained on the study drug after study completion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide + Low-Dose Levetiracetam', 'description': 'Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.'}, {'id': 'OG001', 'title': 'Control Group (High-Dose Levetiracetam)', 'description': 'Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \\>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lacosamide + Low-Dose Levetiracetam', 'description': 'Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.'}, {'id': 'FG001', 'title': 'Control Group (High-Dose Levetiracetam)', 'description': 'Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \\>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Received Lacosamide', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant Reported Increase in Events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Side Effects of Hair Loss and Itchiness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant Stopped Taking Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant No-Show at Multiple Visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lacosamide + Low-Dose Levetiracetam', 'description': 'Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.'}, {'id': 'BG001', 'title': 'Control Group (High-Dose Levetiracetam)', 'description': 'Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \\>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '17.5', 'groupId': 'BG000'}, {'value': '43.7', 'spread': '19.8', 'groupId': 'BG001'}, {'value': '43.4', 'spread': '18.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2011-04-28', 'resultsFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-15', 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Six Month Seizure Freedom', 'timeFrame': '6 Months', 'description': 'Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.'}], 'secondaryOutcomes': [{'measure': 'Number of Seizure-Free Days', 'timeFrame': '6 Months'}, {'measure': 'Time to First Seizure After Therapeutic Dose is Reached', 'timeFrame': '6 Months', 'description': 'Time in days until the first seizure after the therapeutic dose is reached occurs.'}, {'measure': 'Retention Rate', 'timeFrame': '6 Months', 'description': 'Retention rate is defined as the percentage of participants who remained on the study drug after study completion.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAE)', 'timeFrame': '6 Months', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epilepsy', 'antiepileptic drug', 'polytherapy'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '26992155', 'type': 'RESULT', 'citation': 'Lee JW, Alam J, Llewellyn N, Hurwitz S, Bubrick EB, Sarkis RA, Weisholtz D, Yu H, Putta S, Dworetzky BA, Pennell PB. Open Label Trial of Add on Lacosamide Versus High Dose Levetiracetam Monotherapy in Patients With Breakthrough Seizures. Clin Neuropharmacol. 2016 May-Jun;39(3):128-31. doi: 10.1097/WNF.0000000000000144.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults age 18 or older\n2. Determined to have had at least two partial seizures by an epilepsy specialist, or to have had a single partial seizure with clinical and/or laboratory evidence of a high seizure recurrence risk\n3. Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks\n4. Breakthrough seizure while on stable dose (\\>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications)\n\nExclusion Criteria:\n\n1. Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy\n2. Pregnant, child-bearing age not using contraception, or breast feeding\n3. Medical contraindication to adding lacosamide\n4. History of antiepileptic drug (AED) polytherapy\n5. Presence of a vagus nerve stimulator\n6. Creatinine clearance of less than 50 mL/min\n7. Blood pressure instability: pulse \\<50 or \\>100, systolic blood pressure (SBP) \\<50 or \\>180, clinically significant electrocardiogram (EKG) abnormality\n8. History of significant drug rash or anaphylactic reaction with antiepileptic drug\n9. Patients with progressive lesions (e.g. brain tumors)'}, 'identificationModule': {'nctId': 'NCT01345058', 'briefTitle': 'Add on Lacosamide Versus High Dose Monotherapy', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder', 'orgStudyIdInfo': {'id': '2010-P-001630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lacosamide + Low-Dose Levetiracetam', 'description': 'Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.', 'interventionNames': ['Drug: lacosamide', 'Drug: levetiracetam']}, {'type': 'OTHER', 'label': 'Control Group (High-Dose Levetiracetam)', 'description': 'Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \\>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.', 'interventionNames': ['Drug: levetiracetam']}], 'interventions': [{'name': 'lacosamide', 'type': 'DRUG', 'otherNames': ['Vimpat'], 'description': 'Lacosamide maximum of 200 mg/day, to be titrated as follows:\n\n* Week 1: 50 mg twice a day\n* Beginning Week 2: 100 mg twice a day.', 'armGroupLabels': ['Lacosamide + Low-Dose Levetiracetam']}, {'name': 'levetiracetam', 'type': 'DRUG', 'description': 'Low dose ≤1500 mg/day, High dose \\>1500 mg/day', 'armGroupLabels': ['Control Group (High-Dose Levetiracetam)', 'Lacosamide + Low-Dose Levetiracetam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jong Woo Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Neurologist', 'investigatorFullName': 'Jong Woo Lee', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}