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Psych Congress  

Improvements in Clinical Global Impression of Change With Deutetrabenazine Treatment in Tardive Dyskinesia From the ARM-TD and AIM-TD Studies

Hubert Fernandez, MD; Mat Davis, PhD; Stewart Factor, DO; Robert Hauser, MD, MBA; Lars Jarskog, MD; Joohi Jimenez-Shahed, MD; Rajeev Kumar, MD, FRCPC; Stanislaw Ochudlo, MD, PhD; William Ondo, MD; Karen Anderson, MD
Teva Pharmaceutical Industries

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Introduction: Tardive dyskinesia (TD) is an involuntary movement disorder that is often irreversible, can affect any body region, and can be debilitating. In the ARM-TD and AIM-TD studies, deutetrabenazine treatment demonstrated statistically and clinically significant reductions in Abnormal Involuntary Movement Scale (AIMS) scores at Week 12 compared with placebo (primary endpoint).

Objective: To evaluate the efficacy of deutetrabenazine, as measured by the Clinical Global Impression of Change (CGIC) scale, in patients with TD from the pooled ARM-TD and AIM-TD (24 and 36 mg/day doses) data sets, as compared with the pooled placebo cohort.

Methods: ARM-TD and AIM-TD were 12-week, randomized, double-blind, placebo-controlled studies that evaluated the safety and efficacy of deutetrabenazine for the treatment of TD. The key secondary endpoint of each study was the proportion of patients "much improved" or "very much improved" (treatment success) at Week 12 on the CGIC.

Results: At Week 12, the odds of treatment success among patients treated with deutetrabenazine (n=152) was more than double that of patients given placebo (n=107; odds ratio: 2.12; P=0.005). In a categorical analysis of CGIC ratings, patients treated with deutetrabenazine showed greater improvement than patients given placebo (P=0.003). Patients treated with deutetrabenazine also had a significantly better treatment response than those given placebo (least-squares mean CGIC score treatment difference: -0.4; P=0.006)

Conclusions: Deutetrabenazine treatment led to statistically and clinically significant improvements in TD symptoms based on the CGIC result, suggesting that clinicians were able to recognize the benefit in patients treated with deutetrabenazine.

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