Actively Recruiting

Age: 10Years +
MALE
NCT06925269

DMD Voice: Qualitative Interviews With Patients and Caregivers

Led by Red Nucleus Enterprise Solutions, LLC · Updated on 2025-04-30

68

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

Sponsors

R

Red Nucleus Enterprise Solutions, LLC

Lead Sponsor

I

Italfarmaco S.A

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

DMD Voice: Qualitative Interviews With Patients and Caregivers

Who Can Participate

Age: 10Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have been treated with givinostat for at least 2 years
  • Patients must be at least 10 years old with signed consent from a parent or legal guardian
  • Patients must be currently taking givinostat
  • Patients must be willing and able to participate in a video or audio recorded interview
  • Caregivers must be a parent or legal guardian of an individual with DMD treated with givinostat for at least 2 years
  • Caregivers must be willing and able to participate in a video or audio recorded interview
  • Caregivers must provide care to an individual with DMD who cannot raise their hands above their head
  • Caregivers must reside in the United States or Canada
  • Caregivers must be able to read, speak, and understand English
  • Caregivers must be willing and able to participate in a video or audio recorded interview
  • Caregivers must have access to a stable internet connection
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Red Nucleus

Yardley, Pennsylvania, United States, 19067

Actively Recruiting

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Research Team

M

Mary Hubbard

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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