Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-01 @ 3:22 PM
Study NCT ID:
NCT01863602
Status:
COMPLETED
Last Update Posted:
2016-11-09
First Post:
2012-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Special Drug Use Investigation for LAMICTAL® (Long Term)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000077213', 'term': 'Lamotrigine'}], 'ancestors': [{'id': 'D014227', 'term': 'Triazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 850}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-08', 'studyFirstSubmitDate': '2012-10-04', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of adverse drug reactions', 'timeFrame': '1 year'}, {'measure': 'Occurrence of skin disorder after the start of treatment', 'timeFrame': '1 year', 'description': 'Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item'}], 'secondaryOutcomes': [{'measure': "Overall improvement of subjects' symptoms", 'timeFrame': '1 year', 'description': 'Investigators will assess the overall improvement as "remarkably improved". "improved", "slightly improved", "unchanged" or "worsened" on the basis of the degree of change in frequency of seizures, strength, span and other related symptoms.'}]}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED), and to confirm its efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (\\>=15 to \\<65 years) and pediatric (\\>=2 to \\<15 years) subjects with epilepsy with the following seizure type who use lamotrigine tablets\n\n* Partial seizures\n* Tonic-clonic seizures\n* Generalized seizures of Lennox-Gastaut syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome\n* Subjects who are treated with lamotrigine tablets\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01863602', 'briefTitle': 'Special Drug Use Investigation for LAMICTAL® (Long Term)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Special Drug Use Investigation for LAMICTAL (Long Term)', 'orgStudyIdInfo': {'id': '112728'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects prescribed lamotrigine tablets', 'description': 'Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered.', 'interventionNames': ['Drug: Lamotrigine tablets']}], 'interventions': [{'name': 'Lamotrigine tablets', 'type': 'DRUG', 'description': 'Administered for long-term according to the prescribing information in the locally approved label by the authorities.', 'armGroupLabels': ['Subjects prescribed lamotrigine tablets']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}