2026 American Academy of Neurology Abstract Website

Eduardo Dunayevich¹, Mercedes Perez², Ashok Parameswaran¹, Morgan Bron¹, Ericha Franey¹, Donna Sparta¹, Sara Gao¹, Hui Zhang¹, Susan Mathias³, Gustavo Alva⁴, Christoph Correll⁵
¹Neurocrine Biosciences, Inc., ²Icahn School of Medicine at Mount Sinai, ³Health Outcomes Solutions, ⁴University of California Riverside Medical School; Hoag Hospital; ATP Clinical Research, ⁵The Zucker Hillside Hospital; The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell; Charité Universitätsmedizin

Objective:

To evaluate the effects of once-daily valbenazine on quality of life (QoL) in patients with tardive dyskinesia (TD).

Background:

Valbenazine is approved for TD, which is associated with physical, social, and emotional impacts. KINECT-PRO™ (NCT05859698) is the first clinical trial to assess and report the effects of an approved TD medication (valbenazine) on QoL using multiple validated PROs.

Design/Methods:

KINECT-PRO included: 4-week treatment with valbenazine 40 mg; 12-week continuation with 40 mg or increase to 60 or 80 mg; and 8-week stable dosing with 40, 60, or 80 mg. Participants had mild-to-severe TD movement severity (per Abnormal Involuntary Movement Scale [AIMS] item 8) and awareness of TD with mild-to-severe associated distress (per AIMS item 10). Changes from baseline (CFBs) to Wk24 for 3 PROs were primary endpoints: Tardive Dyskinesia Impact Scale (TDIS, psychometrically validated to measure TD impacts); Sheehan Disability Scale (SDS, measuring functional impairment); and EuroQoL Group’s EQ Visual Analog Scale (EQ-VAS, measuring health status/health-related QoL). CFB to Wk24 in AIMS total score and percentage of participants meeting AIMS remission threshold (score ≤1 on items 1-7) were also assessed. Outcomes were analyzed overall and in subgroups defined by TD movement severity (mild, moderate/severe) and by psychiatric diagnosis (schizophrenia/schizoaffective disorder, mood disorder).

Results:

At Wk24, mean CFBs indicated improvements across all outcomes (overall [n=45], TD-Mild [n=20], TD-Mod/Sev [n=25]): TDIS (-8.0, -6.8, -8.9); SDS Social/Leisure (-2.3, -1.8, -2.8); SDS Family/Home (-1.6, -1.3, -1.8); EQ-VAS (+13.1, +12.8, +13.3); AIMS (-6.8, -5.6, -7.8). Overall, 57.8% (26/45) of participants met the AIMS remission threshold at Wk24. PRO and AIMS improvements were observed in both psychiatric diagnosis subgroups. Safety and tolerability were consistent with valbenazine’s known profile.

Conclusions:

Substantial improvements in QoL and TD severity were observed after 24 weeks of once-daily valbenazine, even in study participants with milder TD movements at baseline.