Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00299793
Status:
COMPLETED
Last Update Posted:
2007-03-23
First Post:
2006-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of Lamotrigine
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'lastUpdateSubmitDate': '2007-03-22', 'studyFirstSubmitDate': '2006-03-03', 'studyFirstSubmitQcDate': '2006-03-03', 'lastUpdatePostDateStruct': {'date': '2007-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-07', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Epilepsy', 'Quality of life'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess efficacy, safety and tolerability of lamotrigine as used in a natural clinical setting, to examine the positive effects of lamotrigine, and the reasons why some patients choose to continue or discontinue lamotrigine.', 'detailedDescription': "There have been numerous randomized, double-blind controlled trials demonstrating the value of lamotrigine in the treatment of seizures. However, randomized trials take place in artificial experimental conditions with many restrictions imposed. There hasn't been much focus on positive effects on the patient, such as improvement in mood and level of alertness related to the drug. Other factors related to quality of life that affect the decision to continue or discontinue the drug are also important. Anecdotal experience suggests that lamotrigine is associated with increased alertness, enhanced energy levels and improved general sense of well-being. Observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing anti-epileptic drugs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are about to be prescribed lamotrigine as an appropriate treatment for their epileptic disorder\n\nExclusion Criteria:\n\n* Patients with mental retardation'}, 'identificationModule': {'nctId': 'NCT00299793', 'briefTitle': 'Observational Study of Lamotrigine', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Observational Study of Lamotrigine', 'orgStudyIdInfo': {'id': '01.08.110'}}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'overallOfficials': [{'name': 'Alan Ettinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}]}}}