Session Information
Date: Tuesday, June 6, 2017
Session Title: Drug-Induced Movement Disorders
Session Time: 1:45pm-3:15pm
Location: Exhibit Hall C
Objective: To examine response rates between patients receiving deutetrabenazine and placebo. Response levels were pre-specified from 10–90% improvement from baseline in Abnormal Involuntary Movement Scale (AIMS) scores, in 10% increments.
Background: Tardive dyskinesia (TD) is an involuntary movement disorder with a high unmet need. In the AIM-TD study, clinically significant reductions in AIMS scores were observed with deutetrabenazine 24 mg/day and 36 mg/day at Week 12 versus placebo.
Methods: AIM-TD was a 12-week, Phase III, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of deutetrabenazine 12 mg/day, 24 mg/day, and 36 mg/day for the treatment of TD. AlMS score was assessed by blinded central video rating. The cumulative proportion (10–90% improvement) of AIMS responders and proportion of patients achieving a ≥50% improvement from baseline to Week 12 were secondary endpoints.
Results: For response levels of 10–80%, patients receiving deutetrabenazine 24 mg/day (n=49) and 36 mg/day (n=55) had higher odds of being a responder compared with placebo (n=58) (odds ratio [OR] >1). Patients receiving 36 mg/day also had higher odds of being a responder versus placebo at 90%. More patients receiving 24 mg/day and 36 mg/day were responders versus placebo at ≥10% (OR: 24 mg/day, 2.09; 36 mg/day, 2.40), ≥20% (OR: 2.28; 2.41), ≥30% (OR: 2.15; 2.43), ≥40% (OR: 4.41; 3.96), ≥60% (OR: 4.84; 4.08), ≥70% (OR: 7.92; 10.76), ≥80% (OR: 1.22; 8.06); and more patients taking 36 mg/day were responders at ≥90% (OR: 3.15) response level. Clinically significant improvements (≥50%) were observed in patients taking deutetrabenazine 24 mg/day (OR: 3.96, P=0.005) and 36 mg/day (OR: 3.80, P=0.007) compared with placebo. Treatment was generally well tolerated.
Conclusions: In AIM-TD, the odds of response to deutetrabenazine treatment were higher than the odds of response to placebo at all response levels, including those ≥50%, indicating clinically meaningful benefit of treatment.
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 is Associated with an Improvement in Involuntary Movements in Patients With Tardive Dyskinesia as Seen by the High Proportion of Responders to Deutetrabenazine Treatment in the AIM-TD Study [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/deutetrabenazine-is-associated-with-an-improvement-in-involuntary-movements-in-patients-with-tardive-dyskinesia-as-seen-by-the-high-proportion-of-responders-to-deutetrabenazine-treatment-in-the-aim-td/. Accessed May 17, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/deutetrabenazine-is-associated-with-an-improvement-in-involuntary-movements-in-patients-with-tardive-dyskinesia-as-seen-by-the-high-proportion-of-responders-to-deutetrabenazine-treatment-in-the-aim-td/