Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT03445832
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2018-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulmonary Function and Neuromuscular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2018-02-20', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FVC (Forced Vital Capacity)', 'timeFrame': 'Year 12', 'description': 'Percentage of decrease of FVC sitting or lying down'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromuscular Diseases']}, 'descriptionModule': {'briefSummary': 'This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases : Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in Besançon university hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children suffering from neuromuscular diseases and followed-up in Besançon University Hospital between 2006/01/01 and the beginning of this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neuromuscular disease\n* Followed-up in Besançon University Hospital\n* With at least 2 Pulmonary Function Tests previously performed\n\nExclusion Criteria:\n\n* Mental deficiency\n* Facial expressions disorders'}, 'identificationModule': {'nctId': 'NCT03445832', 'acronym': 'PREMDEN', 'briefTitle': 'Pulmonary Function and Neuromuscular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Pulmonary Function and Neuromuscular Disease', 'orgStudyIdInfo': {'id': 'P/2017/346'}}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}