Session Time: 1:45pm-3:15pm
Location: Exhibit Hall C
Objective: To determine the impact of dopamine-receptor antagonist (DRA) use at baseline on the efficacy, safety, and tolerability of deutetrabenazine in patients with tardive dyskinesia (TD).
Background: TD results from DRA exposure. Continued administration of DRAs may mask and eventually worsen symptoms. Treating TD without disrupting treatment for any underlying psychiatric condition is optimal. Clinically significant reductions in involuntary movements with deutetrabenazine treatment were seen the AIM-TD study.
Methods: In AIM-TD, patients meeting study criteria were randomized (1:1:1:1) to receive fixed-dose deutetrabenazine (12 mg/day, 24 mg/day, 36 mg/day) or placebo. Randomization was stratified on baseline DRA use (currently taking or not). The primary endpoint of mean change in Abnormal Involuntary Movement Scale (AIMS) score from baseline to Week 12 was analyzed, taking into consideration patients’ use of DRAs at baseline.
Results: Least-squares (LS) mean change in AIMS score at Week 12 in patients taking DRA at baseline was –3.4 points for 36 mg/day (n=35; treatment difference –1.7, P=0.017), –3.2 points for 24 mg/day (n=37; –1.5, P=0.036), and –2.0 points for 12 mg/day (n=45; –0.2, P=0.745), compared with –1.7 points in placebo (n=45). LS mean change in AIMS at Week 12 in patients not taking DRAs at baseline was –3.1 points for 36 mg/day (n=20; –3.0, P=0.006), –3.1 points for 24 mg/day (n=12; –3.0, P=0.013), and –2.4 points for 12 mg/day (n=15; –2.4, P=0.048), compared with 0 points in placebo (n=13). The overall incidence of adverse events was similar to that of placebo in all groups, regardless of baseline DRA use.
Conclusions: Regardless of DRA use, fixed-dose regimens of deutetrabenazine provided clinically significant reductions in abnormal involuntary movements of TD, and showed a favorable safety/tolerability profile. Greater reductions were observed in patients not taking DRAs, possibly due to masking of TD symptoms by DRAs.
Presented at: AAN annual meeting; April 22–28, 2017; Boston, MA, USA
To cite this abstract in AMA style:J. Jimenez-Shahed, H. Fernandez, D. Stamler, M. Davis, S. Factor, R. Hauser, J. Isojärvi, W. Ondo, K. Anderson. Deutetrabenazine Treatment Response by Concomitant Dopamine-Receptor Antagonists in the Phase III, Randomized, Double-Blind, Placebo-Controlled AIM-TD Trial in Tardive Dyskinesia [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/deutetrabenazine-treatment-response-by-concomitant-dopamine-receptor-antagonists-in-the-phase-iii-randomized-double-blind-placebo-controlled-aim-td-trial-in-tardive-dyskinesia/. Accessed December 11, 2023.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/deutetrabenazine-treatment-response-by-concomitant-dopamine-receptor-antagonists-in-the-phase-iii-randomized-double-blind-placebo-controlled-aim-td-trial-in-tardive-dyskinesia/