Abstract Details

Title A Wearable Movement Sensor Substudy of KINECT®-HD, a Phase 3 Trial of Valbenazine for the Treatment of Chorea Associated with Huntington’s Disease

Topic Movement Disorders

Presentation(s) P8 - Poster Session 8 (5:30 PM-6:30 PM)

Poster/Presentation
Number 3-010

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.

Authors/Disclosures
Sean Hinton, PhD (Neurocrine Biosciences) PRESENTER	Dr. Hinton has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Dr. Hinton has stock in Neurocrine Biosciences, Inc..
Jamie L. Adams, MD (University of Rochester Medical Center)	Dr. Adams has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Adams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Michael J. Fox Foundation. Dr. Adams has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BioSensics. The institution of Dr. Adams has received research support from NIH/NINDS. The institution of Dr. Adams has received research support from Biogen. The institution of Dr. Adams has received research support from The Michael J. Fox Foundation. The institution of Dr. Adams has received research support from Critical Path Institute. Dr. Adams has received personal compensation in the range of $500-$4,999 for serving as a KINECT-HD Steering Committee Member with Huntington Study Group. Dr. Adams has received personal compensation in the range of $500-$4,999 for serving as a ORCHESTRA-PD Steering Committee Member with Parkinson Study Group.
Erin Furr-Stimming, MD, FAAN (University of Texas Health Science Center-Houston)	Dr. Furr-Stimming has received personal compensation for serving as an employee of Help4HD International. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedPage. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PTC Therapeutics. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Wave Life Sciences. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Latus Bio. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Atalanta Therapeutics. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SkyHawk Therapeutics. Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . Dr. Furr-Stimming has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Atalanta Therapeutics. The institution of Dr. Furr-Stimming has received research support from Roche/Genetech. The institution of Dr. Furr-Stimming has received research support from Uniqure. The institution of Dr. Furr-Stimming has received research support from CHDI. The institution of Dr. Furr-Stimming has received research support from Huntington Study Group/Neurocrine Bioscienes. The institution of Dr. Furr-Stimming has received research support from NIH/University of Iowa. The institution of Dr. Furr-Stimming has received research support from Sage Therapeutics. The institution of Dr. Furr-Stimming has received research support from HDSA. The institution of Dr. Furr-Stimming has received research support from Prilennia. Dr. Furr-Stimming has received publishing royalties from a publication relating to health care. Dr. Furr-Stimming has received publishing royalties from a publication relating to health care. Dr. Furr-Stimming has a non-compensated relationship as a Committee member with AAN UES Committee that is relevant to AAN interests or activities.
Daniel O. Claassen, MD, FAAN (Vanderbilt University Medical Center)	Dr. Claassen has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Alterity. Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Claassen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AskBio. Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for University of Michigan. Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cognition Therapeutics . Dr. Claassen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amylyx. The institution of Dr. Claassen has received research support from NIH. The institution of Dr. Claassen has received research support from CHDI. The institution of Dr. Claassen has received research support from HDSA. The institution of Dr. Claassen has received research support from Department of Defense. The institution of Dr. Claassen has received research support from CHDI.
Elise P. Kayson, RN	Elise Paulin Kayson, RN has nothing to disclose.
Jody Goldstein (Huntington Study Group)	No disclosure on file
Olga Klepitskaya, MD, FAAN (Neurocrine Biosciences, Inc)	Dr. Klepitskaya has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Dr. Klepitskaya has or had stock in Neurocrine Biosciences.
Hui Zhang (Neurocrine Bioscience)	Hui Zhang has received personal compensation for serving as an employee of Neurocrine Bioscience Inc..
Grace L. Liang, MD	Dr. Liang has received personal compensation for serving as an employee of Neurocrine Biosciences. Dr. Liang has stock in Neurocrine Biosciences.
Kelly Lin (Neurocrine Biosciences, Inc.)	No disclosure on file
Sean Mitchell (Neurocrine Biosciences Inc.)	No disclosure on file
Dietrich Haubenberger, MD, FAAN (Neurocrine Biosciences)	Dr. Haubenberger has received personal compensation for serving as an employee of Neurocrine Biosciences, Inc. Dr. Haubenberger has stock in Neurocrine Biosciences. Dr. Haubenberger has a non-compensated relationship as a Member of the Board with American Society for Experimental Neurotherapeutics that is relevant to AAN interests or activities.

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