Objective: To determine the efficacy of deutetrabenazine in patients with TD as measured by CGIC.

Background: TD is often irreversible and can affect any body region. Deutetrabenazine has been studied in two randomized, double-blind, placebo-controlled trials, ARM-TD and AIM-TD, for treatment of TD.

Methods: AIM-TD, a 12-week Phase III, randomized, double-blind, placebo-controlled study, evaluated the safety and efficacy of fixed-dose regimens (12 mg/day, 24 mg/day, and 36 mg/day) of deutetrabenazine for treatment of TD. Change from baseline to Week 12 in Abnormal Involuntary Movement Scale (AIMS) scores was the primary endpoint. The key secondary endpoint was the proportion of patients “much improved” or “very much improved” (treatment success) at Week 12 on CGIC, the investigator’s overall assessment of treatment response. Spearman correlation was used to analyze the relationship between change from baseline in site-rated AIMS and CGIC.

Results: At Week 12, deutetrabenazine 24 and 36 mg/day led to clinically significant least-squares mean treatment differences in centrally read AIMS (–1.8, P=0.003; –1.9, P=0.001, respectively) and CGIC (–0.6, P=0.002; –0.5, P=0.011) compared with placebo. Odds of treatment success on CGIC with deutetrabenazine 24 mg/day (odds ratio [OR]: 2.71) and 36 mg/day (OR: 2.11) were higher compared with placebo. At Week 12, distribution of CGIC ratings was significantly improved at 24 and 36 mg/day compared with placebo (P=0.003, P=0.017, respectively). There was high correlation between site-rated AIMS scores and CGIC ratings (correlation coefficient: 0.718; 95% CI: 0.643–0.777). Deutetrabenazine showed a favorable safety/tolerability profile, with adverse events and discontinuations similar to those with placebo.

Conclusions: Deutetrabenazine 24 and 36 mg/day led to clinically significant reductions in abnormal involuntary movements in patients with TD based on AIMS and CGIC results. The high correlation between site-rated AIMS ratings and CGIC demonstrates that treating clinicians could recognize reduced severity of movements, making results applicable to clinical practice.

Presented at: AAN annual meeting; April 22–28, 2017; Boston, MA, USA

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MDS Abstracts - https://www.mdsabstracts.org/abstract/addressing-involuntary-movements-in-tardive-dyskinesia-aim-td-improvements-in-clinical-global-impression-of-change-cgic-with-deutetrabenazine-treatment-in-tardive-dyskinesia-td/