Recruiting

Observational Study

Sponsor:

Red Nucleus Enterprise Solutions, LLC

Code:

NCT06925269

Conditions

Duchenne Muscular Dystrophy (DMD)

Eligibility Criteria

Sex: Male

Age: 10+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Duchenne Muscular Dystrophy (DMD)

Study ID

NCT06925269

Start date

Mar 31, 2025

Status verified date

Apr, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 10+

Healthy Volunteers: Not accepted

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:

-

Study Design

Enrollment

68 participants

Anticipated

Interventions and Outcome Measures

Arms

Subsample A - Caregivers

Caregivers of individuals with DMD treated with givinostat for at least 2 years

Subsample A - Patients

Patients with DMD treated with givinostat for at least 2 years

Subsample B - Caregivers

Caregivers of individuals with DMD never treated with givinostat

Primary outcome measure

  • Qualitative Interview [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Mary Hubbard

904-541-9326mhubbard@rednucleus.com

Locations

Red Nucleus

Recruiting

Yardley, Pennsylvania, United States, 19067

Contacts

Mary Hubbard

904-541-9326mhubbard@rednucleus.com

Principal Investigator:

Mindy Leffler

More Information

Sponsor

Red Nucleus Enterprise Solutions, LLC

Last update posted

Apr 30, 2025

Last verified

Apr, 2025

Keywords

  • Duchenne
  • givinostat

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Red Nucleus Enterprise Solutions, LLC on 2025-04-30.