NCT06925269 DMD Voice: Qualitative Interviews With Patients and Caregivers
| NCT ID | NCT06925269 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Red Nucleus Enterprise Solutions, LLC |
| Condition | Duchenne Muscular Dystrophy (DMD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 68 participants in total. It began in 2025-03-31 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: Subsample A - Patients Eligible participants for Subsample A must: * 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 Subsample A - Caregivers Eligible caregivers for Subsample A must: * Be a parent or legal guardian of an individual with DMD that has been taking givinostat for at least two years * Willing and able to participate in a video and/or audio recorded interview Subsample B - Caregivers Eligible caregivers for Subsample B must: * Provide care to an individual with DMD who is unable to raise their hands above their head as confirmed by the caregiver * Reside in the United States or Canada * Able to read, speak, and understand English * Willing and able to participate in a video and/or audio recorded interview Have access to a stable internet connection Exclusion Criteria: \-
Contact & Investigator
Mindy Leffler, M.Ed.
PRINCIPAL INVESTIGATOR
Red Nucleus Solutions
Frequently Asked Questions
Who can join the NCT06925269 clinical trial?
This trial is open to male participants only, aged 10 Years or older, studying Duchenne Muscular Dystrophy (DMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06925269 currently recruiting?
Yes, NCT06925269 is actively recruiting participants. Contact the research team at mhubbard@rednucleus.com for enrollment information.
Where is the NCT06925269 trial being conducted?
This trial is being conducted at Yardley, United States.
Who is sponsoring the NCT06925269 clinical trial?
NCT06925269 is sponsored by Red Nucleus Enterprise Solutions, LLC. The principal investigator is Mindy Leffler, M.Ed. at Red Nucleus Solutions. The trial plans to enroll 68 participants.