Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 6:26 PM
Study NCT ID:
NCT06925269
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DMD Voice: Qualitative Interviews With Patients and Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative Interview', 'timeFrame': '60 minutes', 'description': 'Participants will participate in a semi-structured interview'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Duchenne', 'givinostat'], 'conditions': ['Duchenne Muscular Dystrophy (DMD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand DMD functional losses or abilities and their association with independence and quality of life from the perspective of individuals with DMD and/or and their caregivers.\n\nThis is a qualitative interview study in which individuals with DMD and/or their caregivers will be asked to participate in a semi-structured, approximately 60- minute interview. Interviews will focus on functional abilities and independence. Caregivers and boys with DMD will be interviewed. This study includes no treatment nor intervention; however, some participants are being treated by a drug that is approved in the U.S. and the U.K. and under investigation in other geographies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caregivers of individuals with Duchenne Muscular Dystrophy (DMD) and patients with DMD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubsample A - Patients\n\nEligible participants for Subsample A must:\n\n* Have been treated with Givinostat for at least 2 years\n* Be at least 10 years of age with signed consent of a parent or legal guardian\n* Be currently taking givinostat\n* Willing and able to participate in a video and/or audio recorded interview\n\nSubsample A - Caregivers\n\nEligible caregivers for Subsample A must:\n\n* Be a parent or legal guardian of an individual with DMD that has been taking givinostat for at least two years\n* Willing and able to participate in a video and/or audio recorded interview\n\nSubsample B - Caregivers\n\nEligible caregivers for Subsample B must:\n\n* Provide care to an individual with DMD who is unable to raise their hands above their head as confirmed by the caregiver\n* Reside in the United States or Canada\n* Able to read, speak, and understand English\n* Willing and able to participate in a video and/or audio recorded interview Have access to a stable internet connection\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06925269', 'briefTitle': 'DMD Voice: Qualitative Interviews With Patients and Caregivers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Red Nucleus Enterprise Solutions, LLC'}, 'officialTitle': 'Duchenne Muscular Dystrophy Quality of Life: Qualitative Interviews With Patients and Caregivers', 'orgStudyIdInfo': {'id': 'CAS-ITF001-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subsample A - Caregivers', 'description': 'Caregivers of individuals with DMD treated with givinostat for at least 2 years'}, {'label': 'Subsample A - Patients', 'description': 'Patients with DMD treated with givinostat for at least 2 years'}, {'label': 'Subsample B - Caregivers', 'description': 'Caregivers of individuals with DMD never treated with givinostat'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19067', 'city': 'Yardley', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Hubbard', 'role': 'CONTACT', 'email': 'mhubbard@rednucleus.com', 'phone': '904-541-9326'}, {'name': 'Mindy Leffler', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Red Nucleus', 'geoPoint': {'lat': 40.24566, 'lon': -74.846}}], 'centralContacts': [{'name': 'Mary Hubbard', 'role': 'CONTACT', 'email': 'mhubbard@rednucleus.com', 'phone': '904-541-9326'}], 'overallOfficials': [{'name': 'Mindy Leffler, M.Ed.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Red Nucleus Solutions'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Red Nucleus Enterprise Solutions, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Italfarmaco S.A', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}