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.

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).

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.

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.