Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT03607851
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2018-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Rapid Titration Protocols of Lacosamide
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-16', 'studyFirstSubmitDate': '2018-07-24', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '6 (rapid titration group) or 8 weeks (conventional titration group)', 'description': 'Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.'}], 'secondaryOutcomes': [{'measure': 'Reduction of seizure frequency', 'timeFrame': 'Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group)', 'description': '50% responder rate (percentage of patients achieving a 50% or greater reduction in seizure frequency)'}, {'measure': 'lacosamide drug level in the blood', 'timeFrame': '2 weeks (rapid titration group) or 4 weeks (conventional titration group)', 'description': 'lacosamide drug level 1 week after the day of the daily dose of lacosamide reaches 400 mg/day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Focal Epilepsy']}, 'referencesModule': {'references': [{'pmid': '23859801', 'type': 'BACKGROUND', 'citation': 'Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.'}, {'pmid': '17635557', 'type': 'BACKGROUND', 'citation': 'Ben-Menachem E, Biton V, Jatuzis D, Abou-Khalil B, Doty P, Rudd GD. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007 Jul;48(7):1308-17. doi: 10.1111/j.1528-1167.2007.01188.x.'}, {'pmid': '19183227', 'type': 'BACKGROUND', 'citation': 'Halasz P, Kalviainen R, Mazurkiewicz-Beldzinska M, Rosenow F, Doty P, Hebert D, Sullivan T; SP755 Study Group. Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009 Mar;50(3):443-53. doi: 10.1111/j.1528-1167.2008.01951.x. Epub 2009 Jan 17.'}, {'pmid': '20132285', 'type': 'BACKGROUND', 'citation': 'Chung S, Sperling MR, Biton V, Krauss G, Hebert D, Rudd GD, Doty P; SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010 Jun;51(6):958-67. doi: 10.1111/j.1528-1167.2009.02496.x. Epub 2010 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide', 'detailedDescription': 'The investigators intend to find a way to reduce the titration period of lacosamide. Dosage of lacosamide is increased from 100-200 mg/d to 400 mg/d by three different titration schedule. Safety of lacosamide administration is primary endpoint. 50% responder rate (seizure reduction) and blood level of lacosamide are investigated for secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18-85 years old\n* Patients diagnosed with focal epilepsy\n* Patients subjected to the addition of lacosamide to treat focal onset seizures according to physician's judgement\n* Subjects provided informed consent\n\nExclusion Criteria:\n\n* Subjects who changed other antiepileptic drugs at the beginning of lacosamide treatment\n* Subjects with unstable physical, mental or other disease condition that can impede with accurate evaluation or treatment\n* Subjects with terminal illness or general medical condition that can impede with the participation of the clinical trial\n* Subjects who do not agree with prior consent"}, 'identificationModule': {'nctId': 'NCT03607851', 'briefTitle': 'Efficacy and Safety of Rapid Titration Protocols of Lacosamide', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy and Safety of Rapid Titration Protocols of Lacosamide: An Exploratory Study', 'orgStudyIdInfo': {'id': '0620181410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional titration group', 'interventionNames': ['Drug: Lacosamide - conventional titration']}, {'type': 'EXPERIMENTAL', 'label': 'Rapid titration group 1', 'interventionNames': ['Drug: Lacosamide - rapid titration 1']}, {'type': 'EXPERIMENTAL', 'label': 'Rapid titration group 2', 'interventionNames': ['Drug: Lacosamide - rapid titration 2']}], 'interventions': [{'name': 'Lacosamide - conventional titration', 'type': 'DRUG', 'description': 'Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose at weekly intervals by 50 mg PO BID; up to 200 mg BID', 'armGroupLabels': ['Conventional titration group']}, {'name': 'Lacosamide - rapid titration 1', 'type': 'DRUG', 'description': 'Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week', 'armGroupLabels': ['Rapid titration group 1']}, {'name': 'Lacosamide - rapid titration 2', 'type': 'DRUG', 'description': 'Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose every two days by 50 mg PO BID; up to 200 mg BID', 'armGroupLabels': ['Rapid titration group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dongsan Medical Center', 'class': 'OTHER'}, {'name': 'Konkuk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang Kun Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}