Status:
COMPLETED
NSAA NON-Interventional Study Protocol
Lead Sponsor:
Red Nucleus Enterprise Solutions, LLC
Collaborating Sponsors:
Pfizer
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
All Genders
4-12 years
Brief Summary
The purpose of this non-interventional study is to evaluate the feasibility of remotely administering the North Star Ambulatory Assessment (NSAA) to participants with Duchenne muscular dystrophy (DMD)...
Eligibility Criteria
Inclusion
- Evidence of a signed and dated informed consent document indicating that the participant's legally authorized representative (LAR) has been informed of all pertinent aspects of the study, along with evidence of age-appropriate child assent.
- Confirmed diagnosis of DMD
- Participant with DMD aged 4 to12 (inclusive) at t Enrollment date
- Participant with DMD is ambulatory without assistive devices, braces, or aids throughout the study
- Caregiver has access to and/or willingness to learn use of a smart phone and the iTC study mobile application
- Participant and caregiver are based in the US throughout study
- Participant and caregiver are fluent in the English language (verbally and in writing)
Exclusion
- Non-ambulatory DMD participant at any study timepoint
- Caregiver/participant unwilling or unable to administer/perform the NSAA
- Anticipated deterioration of participant's ambulatory status during the study
Key Trial Info
Start Date :
October 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 13 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06054971
Start Date
October 2 2023
End Date
March 13 2025
Last Update
March 21 2025
Active Locations (1)
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1
Red Nucleus Solutions
Malvern, Pennsylvania, United States, 19355