Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT00994916
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-07-09
First Post:
2009-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015624', 'term': 'Lambert-Eaton Myasthenic Syndrome'}], 'ancestors': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077770', 'term': 'Amifampridine'}], 'ancestors': [{'id': 'D015761', 'term': '4-Aminopyridine'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2019-07', 'lastUpdateSubmitDate': '2019-07-05', 'studyFirstSubmitDate': '2009-10-08', 'studyFirstSubmitQcDate': '2009-10-09', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Lambert-Eaton myasthenic syndrome', '3,4 diaminopyridine'], 'conditions': ['Lambert-Eaton Myasthenic Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).', 'detailedDescription': 'Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained.\n\nThe study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.\n\nThe investigator has a hold on enrolling new subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of LEMS\n2. Over 18 years old\n3. Medically stable\n4. If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study\n\nExclusion Criteria:\n\n1. Known sensitivity to 3,4 DAP\n2. History of past or current seizures\n3. History of severe asthma\n4. Believed by the investigator to be unable to comply with the protocol\n5. Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT00994916', 'briefTitle': 'Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine', 'orgStudyIdInfo': {'id': 'IRB0410047'}}, 'armsInterventionsModule': {'interventions': [{'name': '3,4 diaminopyridine', 'type': 'DRUG', 'description': '3,4 diaminopyridine up to 80 mg daily in divided doses'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Lacomis, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jacobus Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology and Pathology', 'investigatorFullName': 'David Lacomis, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}