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

Background: TD is an involuntary movement disorder that is often irreversible and can affect any body region. In the ARM-TD and AIM-TD studies, DTB treatment demonstrated statistically and clinically significant reductions in Abnormal Involuntary Movement Scale (AIMS) scores at Week 12 compared with placebo (primary endpoint). The CGIC is a 7-point Likert scale ranging from “very much worse” to “very much improved” that provides an overall assessment of treatment response, providing insight into a clinician’s view on the change in the patient’s TD symptoms as well as the occurrence of side effects.

Methods: ARM-TD and AIM-TD were 12-week, randomized, double-blind, placebo-controlled studies that evaluated the safety and efficacy of DTB for the treatment of TD. Patients had baseline AIMS scores ≥6. Change in AIMS score from baseline to Week 12 was the primary endpoint of both studies. 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 (“much improved” or “very much improved”) among patients treated with DTB (n=152) was more than double that of patients treated with placebo (n=107; odds ratio: 2.12; P=0.005). In a shift analysis of all CGIC ratings, patients treated with DTB had greater improvement as assessed by clinicians than that observed with placebo (P=0.003). In addition, the mean CGIC score was significantly more improved in patients treated with DTB than in those treated with placebo at Week 12 (treatment difference: –0.4; P=0.006).

Conclusions: DTB treatment led to statistically and clinically significant improvements in TD symptoms based on CGIC results. These results suggest that a global assessment of patients’ clinical status may be useful to assess DTB therapy in clinical practice.

Presented at: APA annual meeting; May 20–24, 2017; San Diego, CA, USA

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MDS Abstracts - https://www.mdsabstracts.org/abstract/improvements-in-clinical-global-impression-of-change-with-deutetrabenazine-treatment-in-tardive-dyskinesia-from-the-arm-td-and-aim-td-studies/