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Open AccessArticle

Tolerability and Efficacy of Customized IncobotulinumtoxinA Injections for Essential Tremor: A Randomized, Double-Blind, Placebo-Controlled Study

by 1,*, 1,2, 3, 4, 5, 5, 6, 7, 3, 3,†, 3, 8 and 9 on behalf of the Essential Tremor Study Team
1
Lawson Health Research Institute, London, ON N6C2R5, Canada
2
MDDT Inc., London, ON N6G0J3, Canada
3
Merz Pharmaceuticals GmbH, 60318 Frankfurt am Main, Germany
4
Krembil Brain Institute, University Health Network, University of Toronto, Toronto, ON M5T1M8, Canada
5
West Park Healthcare Center, University of Toronto, Toronto, ON M6M2J5, Canada
6
Department of Neurology, University of Manitoba, Winnipeg, MB R3T2N2, Canada
7
Division of Neurology, Dalhousie University, Halifax, NS B3H4R2, Canada
8
Division of Movement Disorders, New York University Langone Medical Center, New York, NY 10016, USA
9
Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA
*
Author to whom correspondence should be addressed.
O.S. was an employee of Merz Pharmaceuticals GmbH at the time the study was conducted.
Toxins 2020, 12(12), 807; https://doi.org/10.3390/toxins12120807
Received: 4 December 2020 / Accepted: 14 December 2020 / Published: 20 December 2020
In this first, double-blind, randomized, placebo-controlled exploratory trial, we evaluate the efficacy and safety of incobotulinumtoxinA and feasibility of using kinematic tremor assessment to aid in the planning of muscle selection in a multicenter setting. Reproducibility of the planning technology to other clinical sites was explored. In this trial (NCT02207946), patients with upper-limb essential tremor (ET) were randomized 2:1 to a single treatment cycle of incobotulinumtoxinA or placebo. A tremor kinematic analytics investigational device was used to define a customized muscle set for injection, related to the pattern of the wrist, forearm, elbow, and shoulder tremor for each patient, and the incobotulinumtoxinA dose per muscle (total ≤ 200 U). Fahn–Tolosa–Marin (FTM) Part B motor performance score, Global Impression of Change Scale (GICS), and kinematic analysis-based efficacy evaluations were assessed. Thirty patients were randomized (incobotulinumtoxinA, n = 19; placebo, n = 11). FTM motor performance scores showed greater improvement with incobotulinumtoxinA versus placebo at Week 4 (p= 0.003) and Week 8 (p= 0.031). The physician-rated GICS score indicated improvement with incobotulinumtoxinA versus placebo at Week 4 (p < 0.05). IncobotulinumtoxinA also decreased accelerometric hand-tremor amplitude versus placebo from baseline to Week 4 (p= 0.004) and Week 8 (p < 0.001), with persistent tremor reduction up to 24 weeks post-injection. IncobotulinumtoxinA produced a slight and transient reduction of maximal grip strength versus placebo; two patients reported localized finger muscle weakness. Customized incobotulinumtoxinA injections decreased tremor severity and improved hand motor function in patients with upper-limb ET after a single injection cycle, with a favorable tolerability profile. The study showed that tremor kinematic analytics technology could be successfully scaled for use in other clinical sites. View Full-Text
Keywords: botulinum toxin; tremor; upper-limb essential tremor; incobotulinumtoxinA; Xeomin; kinematics; clinical-decision support; treatment planning; TremorTek® botulinum toxin; tremor; upper-limb essential tremor; incobotulinumtoxinA; Xeomin; kinematics; clinical-decision support; treatment planning; TremorTek®
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MDPI and ACS Style

Jog, M.; Lee, J.; Scheschonka, A.; Chen, R.; Ismail, F.; Boulias, C.; Hobson, D.; King, D.; Althaus, M.; Simon, O.; Dersch, H.; Frucht, S.; Simpson, D.M., on behalf of the Essential Tremor Study Team; Tolerability and Efficacy of Customized IncobotulinumtoxinA Injections for Essential Tremor: A Randomized, Double-Blind, Placebo-Controlled Study. Toxins 2020, 12, 807. https://doi.org/10.3390/toxins12120807

AMA Style

Jog M, Lee J, Scheschonka A, Chen R, Ismail F, Boulias C, Hobson D, King D, Althaus M, Simon O, Dersch H, Frucht S, Simpson DM on behalf of the Essential Tremor Study Team. Tolerability and Efficacy of Customized IncobotulinumtoxinA Injections for Essential Tremor: A Randomized, Double-Blind, Placebo-Controlled Study. Toxins. 2020; 12(12):807. https://doi.org/10.3390/toxins12120807

Chicago/Turabian Style

Jog, Mandar; Lee, Jack; Scheschonka, Astrid; Chen, Robert; Ismail, Farooq; Boulias, Chris; Hobson, Douglas; King, David; Althaus, Michael; Simon, Olivier; Dersch, Hanna; Frucht, Steven; Simpson, David M. on behalf of the Essential Tremor Study Team 2020. "Tolerability and Efficacy of Customized IncobotulinumtoxinA Injections for Essential Tremor: A Randomized, Double-Blind, Placebo-Controlled Study" Toxins 12, no. 12: 807. https://doi.org/10.3390/toxins12120807

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