Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-01 @ 11:38 PM
Study NCT ID:
NCT01724918
Status:
TERMINATED
Last Update Posted:
2016-09-26
First Post:
2012-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lacosamide IV and EEG/EKG (LIVE) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'whyStopped': 'Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-23', 'studyFirstSubmitDate': '2012-10-31', 'studyFirstSubmitQcDate': '2012-11-07', 'lastUpdatePostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Up to 4 hours after start of infusion'}], 'primaryOutcomes': [{'measure': 'Change in the number of interictal spikes', 'timeFrame': 'One hour before and after drug'}], 'secondaryOutcomes': [{'measure': 'Change in frequency and quantity of background EEG rhythms', 'timeFrame': 'One hour before and after drug'}, {'measure': 'Change in EKG (QT, PR interval and heart rhythm)', 'timeFrame': 'One hour before and after drug'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IV lacosamide', 'focal epilepsy', 'EEG', 'EKG'], 'conditions': ['Focal Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG (electrocardiogram), a test which checks for problems with the electrical activity of the heart.', 'detailedDescription': 'The impact of antiepileptic drugs on the EEG can vary from marked to none. A small number of AEDs also affect the EKG. Lacosamide is a new AED that selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. Information is lacking about the effect of lacosamide on brain and heart rhythms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.\n2. Adult patients 18-65 years\n3. Diagnosis of focal epilepsy\n4. Continuous EEG and video monitoring\n5. Continuous EKG\n6. Active EEG showing frequent spikes, electrographic or clinical seizures\n\nExclusion Criteria:\n\n1. Subject has no IV access.\n2. Subject is hemodynamically unstable.\n3. Previous use of Lacosamide\n4. Primary generalized epilepsy\n5. Non-epileptic seizures\n6. No significant cardiac, renal or hepatic disease\n7. No cardiac arrhythmias including heart block\n8. Subject is a pregnant or lactating woman.'}, 'identificationModule': {'nctId': 'NCT01724918', 'acronym': 'LIVE', 'briefTitle': 'Lacosamide IV and EEG/EKG (LIVE) Study', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Lacosamide IV and EEG/EKG (LIVE) Study', 'orgStudyIdInfo': {'id': 'LIVE 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '100 mg IV', 'description': '100 mg IV lacosamide infused over 30 minutes', 'interventionNames': ['Drug: Lacosamide']}, {'type': 'OTHER', 'label': '200 mg IV', 'description': '200 mg IV lacosamide infused over 30 minutes', 'interventionNames': ['Drug: Lacosamide']}, {'type': 'OTHER', 'label': '400 mg IV', 'description': '400 mg IV lacosamide infused over 30 minutes', 'interventionNames': ['Drug: Lacosamide']}], 'interventions': [{'name': 'Lacosamide', 'type': 'DRUG', 'otherNames': ['Vimpat'], 'armGroupLabels': ['100 mg IV', '200 mg IV', '400 mg IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Richard McLachlan, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Centre, University Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Pharma GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rick McLachlan', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}