A Wearable Movement Sensor Substudy of KINECT®-HD, a Phase 3 Trial of Valbenazine for the Treatment of Chorea Associated with Huntington’s Disease
Jamie Adams1, Erin Furr Stimming2, Daniel Claassen3, Elise Kayson4, Jody Goldstein4, Sean Hinton5, Olga Klepitskaya5, Hui Zhang5, Grace Liang5, Kelly Lin5, Sean Mitchell5, Dietrich Haubenberger5
1University of Rochester Medical Center, 2The University of Texas Health Science Center at Houston, McGovern Medical School, 3Vanderbilt University Medical Center, 4Huntington Study Group®, 5Neurocrine Biosciences, Inc.
Objective:
To assess wearable sensor-derived changes in gait, posture, and chorea among KINECT®-HD trial participants.
Background:
In KINECT-HD, greater chorea improvement was found with once-daily valbenazine versus placebo in adults with Huntington’s disease (HD). This was also the first Phase 3 trial in HD to include a wearable sensors substudy.
Design/Methods:
Substudy sites were selected prior to randomization based on experience. Collection of movement data between study visits was performed using the BioStamp nPoint® system. Participants wore three sensors (one on their chest and one on each anterior thigh) during two periods: Screening Period, 7±2 days after screening visit; and Maintenance Period, 7±2 days after Week 10 visit). Changes from Screening Period to Maintenance Period in truncal chorea and gait asymmetry were analyzed using paired t-tests within each treatment group. Sensor-related adverse events (AEs) were analyzed descriptively.
Results:
Among the 38 KINECT-HD participants who entered the substudy, 27 were included for analysis (valbenazine=12, placebo=15) based on available data and adherence (wore sensors for ≥5 hours/day for ≥5 days during both the Screening Period and Maintenance Period). Significant improvements between the periods were found for truncal chorea and all gait asymmetry measures derived from the wearable sensors in the valbenazine group (all p<0.05) but not the placebo group. Six participants reported any sensor-related AE; all sensor-related AEs were mild. One AE (skin irritation) resulted in sensor removal.
Conclusions:
Consistent with KINECT-HD results, truncal chorea improved with valbenazine in this substudy; all gait asymmetry measures also improved. These results support further exploration of how digital measures can be used to detect meaningful symptom changes in individuals with HD to improve clinical research and care.