Addressing Involuntary Movements in Tardive Dyskinesia (AIM-TD): A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of Deutetrabenazine for the Treatment of Moderate to Severe Tardive Dyskinesia (TD)

This poster was presented at the29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Introduction: TD, a movement disorder with no approved treatments, is characterized by abnormal, involuntary movements that can affect any part of the body. In the ARM-TD trial, deutetrabenazine, a selective VMAT2 inhibitor, significantly reduced Abnormal Involuntary Movement Scale (AIMS) score in patients with moderate/severe TD compared with placebo (-3.0 vs -1.6, P=0.019) and was generally well tolerated.
Objective: To discuss the study design of the Phase III, AIM-TD trial that is evaluating the efficacy, safety, and tolerability of fixed-dose deutetrabenazine in patients with TD (NCT02291861).
Methods: A total of 288 patients with moderate/severe TD have been randomized at baseline in a 1:1:1:1 ratio to receive one of three fixed-dose regimens of deutetrabenazine (12 mg/day, 24 mg/day, 36 mg/day) or placebo. Patients underwent dose escalation during the initial 4 weeks, followed by an 8-week maintenance period and a 1-week washout. Primary endpoint is change in AIMS score from Day 0 to Week 12, assessed by blinded central video rating. Secondary endpoints include treatment success on the Clinical Global Impression of Change and the Patient Global Impression of Change, change in the modified Craniocervical Dystonia Questionnaire, percent change in AIMS, and a display of the cumulative responder rate by percent improvement. Safety and tolerability are being assessed throughout.
Results: AIM-TD recruitment began in October 2014. The study will be completed in 2016.
Conclusions: This trial will evaluate the efficacy, safety and tolerability of fixed-dose regimens of deutetrabenazine for the treatment of TD, which may facilitate dose titration and decrease treatment burden.