DMD Voice: Qualitative Interviews With Patients and Caregivers
ConditionDuchenne Muscular Dystrophy (DMD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age10+
SponsorRed Nucleus Enterprise Solutions, LLC
About this trial
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.
This 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have been treated with Givinostat for at least 2 years
Be at least 10 years of age with signed consent of a parent or legal guardian
Be currently taking givinostat
Willing and able to participate in a video and/or audio recorded interview
Disqualifiers
None
Trial population
Caregivers of individuals with Duchenne Muscular Dystrophy (DMD) and patients with DMD
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
68 Participants
are grouped into 3 trial groupsGroup A: Subsample A - Caregivers
Group B: Subsample A - Patients
Group C: Subsample B - Caregivers
Trial outcomes
Primary outcomes
1
Qualitative Interview
Participants will participate in a semi-structured interview
Time frame
60 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Red Nucleus Enterprise Solutions, LLC
Lead sponsor
Italfarmaco S.A
Collaborator
Source ClinicalTrials.gov