Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-04-17 @ 1:53 AM
Study NCT ID:
NCT01825395
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2021-10-06
First Post:
2013-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2013-03-22', 'studyFirstSubmitQcDate': '2013-04-04', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Lambert Eaton Myasthenic Syndrome']}, 'descriptionModule': {'briefSummary': 'To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older,\n* Diagnosed with LEMS,\n* If female, have a negative pregnancy test, and\n* If premenopausal, be willing to practice an effective form of birth control during the study,\n* Tested and found by ECG not to have a prolonged QT syndrome,\n* Agree to have a second ECG at the time of peak drug effect,\n* Has understood and signed the Informed Consent.\n\nExclusion Criteria:\n\n* Is known to have a sensitivity to 3, 4-DAP,\n* Has a history of:\n\n 1. past or current seizures,\n 2. cardiac arrhythmia,\n 3. hepatic, renal or hematologic disease, or\n 4. severe asthma,\n* Is believed by the investigator to be unable to comply with the protocol.'}, 'identificationModule': {'nctId': 'NCT01825395', 'acronym': '3 4-DAP', 'briefTitle': 'Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)', 'orgStudyIdInfo': {'id': '04-0567'}}, 'armsInterventionsModule': {'interventions': [{'name': '3, 4-Diaminopyridine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Steven P Ringel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}