Objective: To evaluate the efficacy, safety, and tolerability of deutetrabenazine in patients with tardive dyskinesia (TD).

Background: AIM-TD is the second large 12-week, Phase III, randomized, double-blind, placebo-controlled, parallel-group study of deutetrabenazine in TD. In the previous 12-week, Phase II/III, randomized, placebo-controlled trial, ARM-TD, deutetrabenazine significantly improved TD compared with placebo on the Abnormal Involuntary Movement Scale (AIMS) (–3.0 vs –1.6, P=0.019) and was generally well tolerated.

Methods: Patients with TD and baseline AIMS rating ≥6 (items 1–7) as assessed by blinded central video rating were randomized 1:1:1:1 to receive one of three fixed-dose regimens of deutetrabenazine (12 mg/day, 24 mg/day, 36 mg/day) or placebo. The primary efficacy endpoint was change in AIMS from baseline to Week 12. The key secondary endpoint was treatment success (proportion of patients who were “much improved” or “very much improved”) on the Clinical Global Impression of Change (CGIC) at Week 12. Adverse events (AEs), clinical labs, and 12-lead ECGs were monitored.

Results: The least-squares (LS) mean AIMS score from baseline to Week 12 improved by –3.3 points for deutetrabenazine 36 mg/day (treatment difference –1.9, P=0.001), –3.2 points for 24 mg/day (–1.8, P=0.003), and –2.1 points for 12 mg/day (–0.7, P=0.217) compared with –1.4 points in placebo. On the CGIC, treatment success was achieved in 44% of patients taking 36 mg/day (P=0.059) and 49% taking 24 mg/day (P=0.014) versus 26% taking placebo. The AE incidence in all deutetrabenazine-treated patients (47.1%) was similar to that of the placebo group (47.2%); most AEs were mild or moderate. Discontinuations for AEs and serious AEs occurred at similar rates between groups.

Conclusions: Deutetrabenazine at 24 mg/day and 36 mg/day provided clinically significant benefits, including reduction in abnormal involuntary movements as shown by change in AIMS scores. Improvements were appreciated by clinicians, shown by improvements on the CGIC. Fixed-dose deutetrabenazine was generally well tolerated.

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-efficacy-safety-and-tolerability-of-fixed-dose-deutetrabenazine-for-the-treatment-of-tardive-dyskinesia/