Session Information
Date: Wednesday, June 22, 2016
Session Title: Huntington's disease
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: To assess the effect of deutetrabenazine treatment on balance using the BBT in patients with HD in First-HD.
Background: Patients with HD have disrupted balance that may be in part due to chorea. Balance disturbance can increase the risk of falls, leading to injury.¹ The BBT is a 14-item survey that measures balance and risk of falling (higher score indicates better balance). Based on their mechanism of action, worsened balance is a potential side-effect of lower dopamine effect induced by neuroleptics or vesicular monoamine transporter inhibitors. In First-HD, deutetrabenazine significantly reduced total maximal chorea (TMC) score (primary endpoint; P<.0001) and total motor score (P=.0023) of the Unified Huntington Disease Rating Scale vs placebo and was generally well tolerated.²
Methods: First-HD was a 12-week, double-blind, placebo-controlled, parallel-group study. HD patients (N=90) were randomized 1:1 to receive deutetrabenazine or placebo. The change in TMC from baseline (BL) was the primary endpoint. A prespecified secondary endpoint was change in BBT score from BL to Week 12. Endpoints were assessed at BL and Weeks 2, 4, 6, 9 and 12. Adverse events (AEs) were monitored throughout the study.
Results: Deutetrabenazine treatment showed a trend toward improvement in mean [SD] BBT score compared with placebo at Week 12 (2.2 [3.5] vs 1.3 [4.0]; P=.1415). For patients with more-severe chorea at BL (TMC score ≥12; n=21 deutetrabenazine, n=28 placebo), there was a trend toward greater improvement in BBT with deutetrabenazine versus placebo at Week 12 (treatment difference 1.9; P=.0789). Two (4.4%) deutetrabenazine patients reported a fall vs four (8.9%) in the placebo group. One (2.2%) deutetrabenazine patient reported a mild gait disturbance compared with none in placebo group.
Conclusions: BBT score did not worsen in the deutetrabenazine group. Deutetrabenazine BBT results were mildly better over time, and there were fewer falls reported compared with placebo. These data suggest that deutetrabenazine does not worsen balance in patients with HD with chorea. References: 1. Grimbergen YAM et al. Mov Disord 2008;23:970–976. 2. Huntington Study Group. A Phase 3 Trial of Deutetrabenazine for the Treatment of Chorea Associated with Huntington Disease. Presented at: American Academy of Neurology; April 22, 2015; Washington, DC.
To cite this abstract in AMA style:
D.O. Claassen, D. Oakes, D. Stamler, V. Sung, C.M. Testa, S. Frank, On behalf of the First-HD HSG Investigators. Maintenance of balance function in patients with HD treated with deutetrabenazine, as measured by Berg balance test (BBT) in First-HD [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/maintenance-of-balance-function-in-patients-with-hd-treated-with-deutetrabenazine-as-measured-by-berg-balance-test-bbt-in-first-hd/. Accessed November 22, 2024.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/maintenance-of-balance-function-in-patients-with-hd-treated-with-deutetrabenazine-as-measured-by-berg-balance-test-bbt-in-first-hd/