Findings
SV95C is a promising secondary endpoint for evaluating drug efficacy in ambulant DMD patients aged 5 and above.
The wearable device provides continuous, objective measurements, overcoming the limitations of episodic tests like the 6MWT, which are influenced by patient motivation and clinic settings.
The system demonstrates strong correlation with existing endpoints (e.g., 6MWT, NSAA), but further longitudinal data are needed to establish it as a primary endpoint.
Variability in SV95C decreases significantly with longer recording durations, with 180 hours recommended as optimal.
Combining SV95C with other gait variables could enhance sensitivity to change and predictive capacity for disease progression.

Findings
SV95C is a promising secondary endpoint for evaluating drug efficacy in ambulant DMD patients aged 5 and above.
The wearable device provides continuous, objective measurements, overcoming the limitations of episodic tests like the 6MWT, which are influenced by patient motivation and clinic settings.
The system demonstrates strong correlation with existing endpoints (e.g., 6MWT, NSAA), but further longitudinal data are needed to establish it as a primary endpoint.
Variability in SV95C decreases significantly with longer recording durations, with 180 hours recommended as optimal.
Combining SV95C with other gait variables could enhance sensitivity to change and predictive capacity for disease progression.

Regulatory Considerations
SV95C requires validation in conjunction with traditional endpoints (e.g., 6MWT, NSAA) to support regulatory submissions.
Device and software updates must be accompanied by bridging data to ensure consistent measurement properties.
Patient data privacy and security must comply with regulatory standards, including encryption of recorded data and limited researcher access to identifiers.
Future applications of SV95C as a primary endpoint will require expanded normative datasets and stronger correlation with clinically meaningful outcomes.
Incorporate SV95C in early-phase exploratory trials to build a robust case for its clinical relevance in pivotal studies.