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Chaijale N, Bona J, Barkay H, et al. Deutetrabenazine Reduces Severe Tardive Dyskinesia Movements in a 3-year Open-Label Extension Trial. CNS Spectr. 2021;26(2):156doi: 10.1017/S1092852920002497.
Chaijale, N., Bona, J., Barkay, H., Wilhelm, A., & Gordon, M. F. (2021). Deutetrabenazine Reduces Severe Tardive Dyskinesia Movements in a 3-year Open-Label Extension Trial. CNS spectrums, 26(2), 156. https://doi.org/10.1017/S1092852920002497
Chaijale, Nayla, et al. "Deutetrabenazine Reduces Severe Tardive Dyskinesia Movements in a 3-year Open-Label Extension Trial." CNS spectrums vol. 26,2 (2021): 156. doi: https://doi.org/10.1017/S1092852920002497
Chaijale N, Bona J, Barkay H, Wilhelm A, Gordon MF. Deutetrabenazine Reduces Severe Tardive Dyskinesia Movements in a 3-year Open-Label Extension Trial. CNS Spectr. 2021 Apr;26(2):156. doi: 10.1017/S1092852920002497. PMID: 34127115.
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CNS Spectr. 2021 Apr;26(2):156. doi: 10.1017/S1092852920002497.

Deutetrabenazine Reduces Severe Tardive Dyskinesia Movements in a 3-year Open-Label Extension Trial.

CNS spectrums

Nayla Chaijale, Joseph Bona, Hadas Barkay, Amanda Wilhelm, Mark Forrest Gordon

Affiliations

  1. Teva Pharmaceutical Industries Ltd., West Chester, PA, USA.
  2. Emory University, Atlanta, GA, USA.
  3. Teva Pharmaceutical Industries Ltd., Netanya, Israel.

PMID: 34127115 DOI: 10.1017/S1092852920002497

Abstract

BACKGROUND: There are no established treatment guidelines for tardive dyskinesia (TD) based on movement severity. The 12-week ARM-TD and AIM-TD studies in TD patients with baseline Abnormal Involuntary Movement Scale (AIMS) total score (items 1-7) ≥6 showed clinically significant improvements in AIMS score with deutetrabenazine versus placebo. Patients who completed these studies were eligible for the open-label extension (OLE) trial. This post-hoc analysis evaluated deutetrabenazine in TD patients with severe movements.

METHODS: Subgroups were defined by upper quartile of baseline total AIMS score (local rating). Endpoints were: change and percent change from baseline in AIMS score, and percent of patients achieving ≥50% AIMS reduction from baseline.

RESULTS: 337 patients were analyzed. The upper quartile of baseline total AIMS score was 14. Subgroups were defined as >14 and ≤14 at baseline, respectively (n=64 vs 273); data are presented at Week 145 (n=40 vs 120). Mean treatment duration was 880.5 and 760.8 days. Mean±SE daily doses were 41.1±1.6mg and 38.9±1.0mg. Mean±SE change from baseline in AIMS score was -11.0±0.8 versus -5.1±0.3; percent change from baseline was -60.1%±3.6% versus -55.9%±3.0%. More patients with AIMS score >14 had ≥50% AIMS reduction (73% vs 65%). Less patients discontinued (38% vs 51%); reasons included withdrawal by subject (16% vs 25%), adverse event (3% vs 11%), and lost to follow-up (6% vs 7%). Withdrawal due to lack of efficacy was uncommon (5% vs 2%).

CONCLUSIONS: Patients with baseline total AIMS score >14 had clinically meaningful reductions in AIMS score, suggesting deutetrabenazine has long-term benefit in these patients.

FUNDING: Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.

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