Clinical trials in acute and chronic neurologic conditions traditionally rely on functional assessments using clinical scales that can be insensitive to treatment response and capture a patient’s function at a single timepoint in a clinical setting. In order to assess the relative sensitivity of real-world activity levels for detection of disease progression and/or treatment response compared with in-clinic assessments, we are using wearable digital biosensors to passively collect activity data in 2 multiple sclerosis (MS) clinical trials.
To assess patient biosensor compliance and the potential of real-world digital biosensor data to assess MS disease progression and/or treatment response
Two randomized, double-blind, placebo-controlled, 52-week Phase 2 clinical trials are currently evaluating the efficacy and safety of elezanumab in subjects with relapsing (RADIUS-R, NCT03737851) or progressive (RADIUS-P, NCT03737812) forms of MS. The primary efficacy assessment is performed in-clinic every 12 weeks. To generate real-world activity data, subjects wore MC10’s BioStamp nPoint® biosensors over 7-day intervals at Baseline and Weeks 24, 36, and 52. The sensors (chest, thigh and calf locations) monitor gait speed, step count and overall activity, including vital signs. Study sites were trained to apply, charge and reapply biosensors by MC10, and site staff trained subjects. Compliance was measured by the percentage of sensor wear days out of the instructed wear days.
As of April 9, 2020, RADIUS-R had enrolled 208 subjects, RADIUS-P had enrolled 123 and 119,00 hours of actigraphy data were collected. Interim compliance rates for subjects completing each interval in RADIUS-R and RADIUS-P respectively were: Baseline (n=188, 101%; n=88, 94%), Week 24 (n=84, 99%; n=21, 86%), Week 36 (n=28, 104%; n=5, 103%), Week 52 (n=4, 79%; n=1, 114%). The average compliance rate across the studies and timepoints was 98%. All treatment-blinded actigraphy data were uploaded to the MC10 cloud for review. The objective at the completion of the studies is to determine differences between treatment groups in relation to clinical endpoints.
To our knowledge, these are the first randomized MS clinical trials to incorporate BioStamp biosensors to capture real-world activity. There was a high level of compliance to-date across study sites for the subjects that have completed one or more 7-day intervals, suggesting use is not overly burdensome.