Tolerability and Efficacy of Customized IncobotulinumtoxinA Injections for Essential Tremor: A Randomized,...

Area of Science:

• Neurology
• Movement Disorders
• Pharmacology

Background:

• Essential tremor (ET) is a common neurological disorder affecting upper limb motor function.
• Current treatment options for ET have limitations in efficacy and safety.
• Objective assessment of tremor patterns is crucial for targeted therapeutic interventions.

Purpose of the Study:

• To evaluate the efficacy and safety of incobotulinumtoxinA for treating upper-limb ET.
• To assess the feasibility and reproducibility of using kinematic tremor analysis for customized muscle selection in a multicenter setting.
• To compare incobotulinumtoxinA treatment with placebo in patients with essential tremor.

Main Methods:

• A double-blind, randomized, placebo-controlled, multicenter exploratory trial (NCT02207946) involving 30 patients with upper-limb ET.
• Patients were randomized 2:1 to receive incobotulinumtoxinA or placebo.
• A tremor kinematic analytics device guided customized muscle selection and dosing (≤ 200 U) for injections. Efficacy was assessed using Fahn-Tolosa-Marin (FTM) Part B, Global Impression of Change Scale (GICS), and kinematic analysis.

Main Results:

• IncobotulinumtoxinA demonstrated statistically significant improvements in FTM motor performance scores at Weeks 4 and 8 compared to placebo.
• Physician-rated GICS scores indicated greater improvement with incobotulinumtoxinA at Week 4.
• Accelerometric hand-tremor amplitude was significantly reduced with incobotulinumtoxinA from baseline to Week 8, with sustained reduction up to 24 weeks. Transient grip strength reduction and localized finger weakness were noted in a few patients.

Conclusions:

• Customized incobotulinumtoxinA injections effectively decreased tremor severity and improved hand motor function in upper-limb ET patients after a single treatment cycle.
• The treatment exhibited a favorable tolerability profile.
• Tremor kinematic analytics technology demonstrated feasibility and scalability for multicenter clinical application in guiding ET treatment.