Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-24 @ 3:51 AM
Study NCT ID:
NCT03220256
Status:
UNKNOWN
Last Update Posted:
2017-07-18
First Post:
2017-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077213', 'term': 'Lamotrigine'}], 'ancestors': [{'id': 'D014227', 'term': 'Triazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-14', 'studyFirstSubmitDate': '2017-07-12', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin rash incidence rate', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in Treg cell ratio in peripheral blood', 'timeFrame': '2 weeks'}, {'measure': 'Severity of skin rash (CTCAE version 4.0)', 'timeFrame': '2 weeks'}, {'measure': 'Lamotrigine drug level in blood (mcg/ml)', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lamotrigine Allergy']}, 'referencesModule': {'references': [{'pmid': '25645637', 'type': 'BACKGROUND', 'citation': 'Wang XQ, Xiong J, Xu WH, Yu SY, Huang XS, Zhang JT, Tian CL, Huang DH, Jia WQ, Lang SY. Risk of a lamotrigine-related skin rash: current meta-analysis and postmarketing cohort analysis. Seizure. 2015 Feb;25:52-61. doi: 10.1016/j.seizure.2014.12.001. Epub 2014 Dec 23.'}, {'pmid': '26783356', 'type': 'BACKGROUND', 'citation': 'Murray TS, Rice TW, Wheeler AP, Phillips EJ, Dworski RT, Stollings JL. Medication Desensitization: Characterization of Outcomes and Risk Factors for Reactions. Ann Pharmacother. 2016 Mar;50(3):203-8. doi: 10.1177/1060028015625660. Epub 2016 Jan 18.'}, {'pmid': '17088655', 'type': 'BACKGROUND', 'citation': 'Castells M. Desensitization for drug allergy. Curr Opin Allergy Clin Immunol. 2006 Dec;6(6):476-81. doi: 10.1097/ACI.0b013e3280108716.'}, {'pmid': '22561837', 'type': 'BACKGROUND', 'citation': 'Akdis CA. Therapies for allergic inflammation: refining strategies to induce tolerance. Nat Med. 2012 May 4;18(5):736-49. doi: 10.1038/nm.2754.'}]}, 'descriptionModule': {'briefSummary': 'The investigators intend to find a way to lower drug rash occurrence by applying drug tolerance induction protocol at the beginning of lamotrigine administration.\n\nGenotyping of participants with rash and those without rash after taking lamotrigine and genetic testing to find common gene mutations in these participants.'}, '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* Epilepsy patients\n* Patients who started Lamotrigine first time\n\nExclusion Criteria:\n\n* Those who do not agree with prior consent\n* Women taking oral contraceptives.\n* history of drug rash\n* Taking enzyme-inducing antiepileptic drugs (EIAED) or valproate (VPA)'}, 'identificationModule': {'nctId': 'NCT03220256', 'briefTitle': 'Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Protocol Establishment for the Prevention of Lamotrigine-induced Skin Rash in Epilepsy Patients: A Pilot Study', 'orgStudyIdInfo': {'id': '1605-121-764'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lamotrigine tolerance', 'description': 'The dose of lamotrigine (0.1mg) started to increase and gradually increased according to the drug tolerance induction protocol, and the efficacy was evaluated by dosing to the commercial capacity (100mg bid) within 2 weeks.', 'interventionNames': ['Drug: Lamotrigine']}], 'interventions': [{'name': 'Lamotrigine', 'type': 'DRUG', 'description': 'The dose of lamotrigine (0.1mg) started to increase and gradually increased according to the drug tolerance induction protocol, and the efficacy was evaluated by dosing to the commercial capacity (100mg bid) within 2 weeks. In addition, the ratio of regulatory T cells was measured before lamotrigine administration, and the proportion of regulatory T cells was measured by two-week administration of lamotrigine after tolerance induction protocol. Add 6 ml of EDTA tube to each cryovial, and dispense 1 ml each in cryovial. After the appropriate number of patients of the same phenotype were collected, the analysis was performed.', 'armGroupLabels': ['Lamotrigine tolerance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Kun Lee, MD, PhD', 'role': 'CONTACT', 'email': 'sangkun2923@gmail.com'}, {'name': 'Sang Kun Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang Kun Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}