Actively Recruiting

Age: 10Years +
MALE
ID06925269

Duchenne Muscular Dystrophy Quality of Life: Qualitative Interviews With Patients and Caregivers

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

68

Participants Needed

1

Research Sites

52 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

Researchers are conducting a study to better understand the functional losses or abilities experienced by individuals with Duchenne Muscular Dystrophy (DMD) and how these relate to their independence and quality of life. This study gathers insights from both individuals with DMD and their caregivers through detailed interviews to capture their perspectives. The study is observational and does not involve treatment, though some participants may currently be on a drug called givinostat. The study involves semi-structured interviews lasting about 60 minutes, focusing on functional abilities and independence. Participants include boys with DMD and caregivers, some of whom have been treated with givinostat for at least two years, and others who have not been treated with this drug. Interviews are conducted via video or audio recording, and participants must be willing and able to participate in this format. Participants will be asked to share their experiences during interviews conducted remotely. Researchers will evaluate the qualitative information gathered from these interviews to understand the impact of DMD on daily life and independence. The primary outcome is the content and insights from these 60-minute interviews. The study is expected to continue until December 2026, with participation involving a single interview session.

CONDITIONS

Brief Title

DMD Voice: Qualitative Interviews With Patients and Caregivers

Who Can Participate

Age: 10Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Boys with Duchenne Muscular Dystrophy treated with givinostat for at least 2 years
  • Participants must be at least 10 years old with signed consent from a parent or guardian
  • Currently taking givinostat
  • Willing and able to participate in a video or audio recorded interview
  • Caregivers who are parents or legal guardians of individuals with DMD treated with givinostat for at least 2 years
  • Caregivers who provide care to individuals with DMD unable to 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 have access to a stable internet connection
  • Caregivers willing and able to participate in a video or audio recorded interview
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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Qualitative Interview

Duration - Single session

Participants take part in a 60-minute video or audio recorded interview to share their experiences and perspectives.

1 visit (remote video or audio)

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

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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