Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT04015934
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2019-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors of Long Term Outcome in MMN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-10', 'studyFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of deteriorating or strongly dependant IVIg NMM', 'timeFrame': 'inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['predictive factors'], 'conditions': ['MMN']}, 'descriptionModule': {'briefSummary': 'The cornerstone treatment for multifocal motor neuropathy (MMN), a rare and disabling dysimmune neuropathy, is intravenous immunoglobulin (IVIg). The aim of this study is to identify prognostic factors of poor outcome.\n\nData were retrospectively collected from MNN patients in three French centers. Patients were divided into two groups: a good outcome group and a poor outcome group. Demographic, clinical, biological and nerve conduction study features of MMN patients were analyzed. Identification of prognostic factors in MMN could help develop personalized treatment.', 'detailedDescription': 'The cornerstone treatment for multifocal motor neuropathy (MMN), a rare and disabling dysimmune neuropathy, is intravenous immunoglobulin (IVIg). However, 10% of patients progress despite treatment. The aim of this study is to identify prognostic factors of poor outcome.\n\nData were retrospectively collected from MNN patients in three French centers. Patients were divided into two groups: a good outcome group (patients in remission without IVIg or with spaced IVIg courses), and a poor outcome group (patients dependent on continuous IVIg treatment or deteriorating despite IVIg). Investigators searched predictive factors of long-term outcome in MMN. They studied demographic, clinical, biological and nerve conduction study features of MMN patients.Identification of prognostic factors in MMN could help develop personalized treatment by selecting patients eligible for immunosuppressive drugs before IVIg dependence or progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MMN patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of MNN following the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Guideline criteria 2010\n\nExclusion Criteria:\n\n* missing data\n* clinical progression features suggested another inflammatory neuropathy,\n* immunosuppressive agents for another pathology.'}, 'identificationModule': {'nctId': 'NCT04015934', 'briefTitle': 'Predictive Factors of Long Term Outcome in MMN', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Predictive Factors Identification of Long-term Outcome in Multifocal Motor Neuropathy (MMN) Treated With Intravenous Immunoglobulin (IVIG)', 'orgStudyIdInfo': {'id': 'NMMBC'}}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'Central Hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}