Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-15 @ 4:05 AM
Study NCT ID:
NCT01655394
Status:
UNKNOWN
Last Update Posted:
2014-12-12
First Post:
2012-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change of Nerve Conduction Properties in IVIg Dependent Neuropathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}, {'id': 'D020277', 'term': 'Polyradiculoneuropathy, Chronic Inflammatory Demyelinating'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-11', 'studyFirstSubmitDate': '2012-07-30', 'studyFirstSubmitQcDate': '2012-07-31', 'lastUpdatePostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Improvement', 'timeFrame': '6 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Guillain-Barre Syndrome', 'CIDP', 'Multifocal Motor Neuropathy']}, 'descriptionModule': {'briefSummary': 'IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored.', 'detailedDescription': 'IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with immune neuropathies', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* immune neuropathy\n* age above 18 y\n* IVIg treatment\n\nexclusion:\n\n* no IVIg treatment'}, 'identificationModule': {'nctId': 'NCT01655394', 'briefTitle': 'Change of Nerve Conduction Properties in IVIg Dependent Neuropathies', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Change of Nerve Conduction Properties in IVIg Dependent Neuropathies', 'orgStudyIdInfo': {'id': '01607831337'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cologne', 'country': 'Germany', 'facility': 'University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Helmar C. Lehmann, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. H. Lehmann', 'investigatorFullName': 'Helmar Lehmann', 'investigatorAffiliation': 'University of Cologne'}}}}